[Senate Report 110-521]
[From the U.S. Government Publishing Office]
110th Congress Report
SENATE
2d Session 110-521
======================================================================
RYAN HAIGHT ONLINE PHARMACY CONSUMER PROTECTION ACT OF 2007
_______
November 17 (legislative day, September 17, 2008).--Ordered to be
printed
_______
Mr. Leahy, from the Committee on the Judiciary, submitted the following
R E P O R T
[To accompany S. 980]
[Including cost estimate of the Congressional Budget Office]
The Committee on the Judiciary, to which was referred the
bill (S. 980) to amend the Controlled Substances Act to address
online pharmacies, reports favorably thereon, with an
amendment, and recommends that the bill, as amended, do pass.
CONTENTS
Page
I. Background and Purpose of the Ryan Haight Online Pharmacy Consumer
Protection Act of 2007...........................................1
II. History of the Bill and Committee Consideration..................8
III. Section-by-Section Summary of the Bill..........................12
IV. Congressional Budget Office Cost Estimate.......................17
V. Regulatory Impact Evaluation....................................19
VI. Conclusion......................................................19
VII. Changes to Existing Law Made by the Bill, as Reported...........19
I. Background and Purpose of the Ryan Haight Online Pharmacy Consumer
Protection Act of 2007
Senators Feinstein and Sessions introduced the Online
Pharmacy Consumer Protection Act of 2007 on March 23, 2007.
Senators Biden, Coleman, Leahy, and Cornyn cosponsored the
legislation (renamed the Ryan Haight Online Pharmacy Consumer
Protection Act of 2007).
This legislation responds to the increasing use of
prescription controlled substances by adolescents and others
for non-medical purposes, which has been exacerbated by drug
trafficking on the Internet. The Department of Justice (DOJ)
has acknowledged that this ``is a very significant problem and
is a major concern of DOJ and the DEA.''\1\
---------------------------------------------------------------------------
\1\Oversight of the U.S. Department of Justice: Hearing Before the
S. Comm. on the Judiciary, 110th Cong. (Jan. 18, 2007) [hereinafter
Jan. 2007 DOJ Hearing], Responses to Questions for the Record Posed to
Alberto Gonzales, Att'y Gen. of the United States at 11.
---------------------------------------------------------------------------
A. BACKGROUND
The Ryan Haight Online Pharmacy Consumer Protection Act of
2007 is the latest in a series of bills introduced to address
the problem of rogue Internet pharmacies. The current
legislation has origins in, but has also been modified
substantially from, previous bills: S. 3834, the Online
Pharmacy Consumer Protection Act of 2006, introduced by
Senators Sessions and Feinstein in the 109th Congress; S. 399,
the Internet Pharmacy Consumer Protection Act, introduced by
Senators Coleman and Feinstein in the 109th Congress; and S.
2464, the Internet Pharmacy Consumer Protection Act, introduced
by Senators Coleman and Feinstein in the 108th Congress.
B. NEED FOR LEGISLATION
1. The alarming rise in abuse of prescription controlled substances
Over the past decade, the United States has experienced a
growing epidemic of prescription controlled substance abuse
involving opiates like OxyContin and Vicodin, depressants like
Valium and Xanax, and stimulants like Ritalin and Adderall. As
Joseph A. Califano, Jr., former U.S. Secretary of Health,
Education and Welfare and now President and Chief Executive
Officer of the National Center on Addiction and Substance Abuse
(CASA) at Columbia University, testified before this Committee,
``Over the past 12 years, the fastest growing drug abuse among
our Nation's children involves prescription drugs.''\2\
---------------------------------------------------------------------------
\2\Rogue Online Pharmacies: the Growing Problem of Internet Drug
Trafficking: Hearing Before the S. Comm. on the Judiciary, 110th Cong.
(2007) [hereinafter Rogue Online Pharmacies Hearing] (testimony of
Joseph A. Califano, President and Chief Executive Officer, Nat'l Ctr.
on Addiction and Substance Abuse).
---------------------------------------------------------------------------
In its 2005 report, Under the Counter: The Diversion and
Abuse of Controlled Prescription Drugs in the U.S., the
National Center on Addiction & Substance Abuse (CASA) reported
that, from 1992 to 2002, prescriptions written for such
controlled drugs increased more than 150 percent, 12 times the
rate of increase in population and almost three times the rate
of increase in prescriptions written for all other drugs.\3\
The number of 12- to 17-year-olds who abused controlled
prescription drugs jumped 212 percent and the number of adults
18 and older abusing such drugs climbed 81 percent. Abuse of
prescription controlled substances has grown at a rate twice
that of marijuana abuse; five times that of cocaine abuse; and
60 times that of heroin abuse.\4\
---------------------------------------------------------------------------
\3\Under the Counter: The Diversion and Abuse of Controlled
Prescription Drugs in the U.S., Nat'l Ctr on Addiction & Substance
Abuse (CASA) at Columbia Univ., July 2005, at 3, available at http://
www.casacolumbia.org/absolutenm/articlefiles/380-
Under%20the%20Counter%20-%20Diversion.pdf.
\4\Id. at 16.
---------------------------------------------------------------------------
Mr. Califano told the Committee about the troubling
implications that prescription drug abuse posed to children.
From 1992 to 2002, new abuse of prescription opiates among 12-
to 17-year-olds was up an astounding 542 percent, more than
four times the rate of increase among adults. In 2003, 2.3
million 12- to 17-year-olds (nearly one in 10) abused at least
one prescription controlled substance; for 83 percent of them,
the drug was an opiate. According to Califano, ``Teens who
abuse controlled prescription drugs are twice as likely to use
alcohol, five times likelier to use marijuana, 12 times
likelier to use heroin, 15 times likelier to use ecstasy and 21
times likelier to use cocaine, compared to teens who do not
abuse such drugs.''\5\
---------------------------------------------------------------------------
\5\Rogue Online Pharmacies Hearing, supra note 2.
---------------------------------------------------------------------------
Joseph T. Rannazzisi, Deputy Assistant Administrator of the
Office of Diversion Control at the U.S. Drug Enforcement
Administration (DEA), confirmed in testimony before the
Committee that there has been an ``alarming'' increase in non-
medical use of addictive prescription drugs. Nationally, misuse
of prescription drugs was second only to marijuana in 2005, in
part due to a false sense of security associated with the abuse
of prescription substances. Mr. Rannazzisi testified that
``many feel as though if a doctor can prescribe it, the drug
can't be as harmful to your health [as illegal drugs sold on
the street].''\6\ In reality, however, prescription controlled
substances are not just highly dangerous, but also potentially
lethal. The consequences for people who seek prescription
controlled drugs illegally over the Internet can be severe.
According to the DEA, abuse of prescription drugs can be just
as dangerous and deadly as the consequences of abusing cocaine
and heroin.
---------------------------------------------------------------------------
\6\Rogue Online Pharmacies Hearing, supra note 2 (testimony of
Joseph T. Rannazzisi, Deputy Assistant Adm'r, Office of Diversion
Control, U.S. Drug Enforcement Admin.).
---------------------------------------------------------------------------
In testimony before the Committee at a Department of
Justice Oversight hearing in January 2007, Attorney General
Alberto Gonzales confirmed that the Department was concerned
about the non-medical use of prescription controlled
substances, and he verified that such drugs were ``the fastest
rising category of drug abuse in recent years.''\7\
---------------------------------------------------------------------------
\7\Jan. 2007 DOJ Hearing, supra note 1, (statement of Alberto
Gonzales, former Att'y Gen. of the United States); see also, Department
of Justice Oversight: Hearing Before the S. Comm. on the Judiciary,
110th Cong. (April 19, 2007) [hereinafter Apr. 2007 DOJ Hearing]
(statement of Alberto Gonzales, former Att'y Gen. of the United
States).
---------------------------------------------------------------------------
President George W. Bush has also acknowledged the growing
problem of prescription drug abuse. On March 1, 2008, in his
national radio address, President Bush noted that abuse of
prescription drugs among the Nation's youth was a growing
problem, and that the total number of Americans who have died
from prescription drug overdoses was also increasing.\8\
---------------------------------------------------------------------------
\8\President George W. Bush, Radio Address: 2008 National Drug
Control Policy (Mar. 1, 2008) [hereinafter Bush Radio Address],
available at http://www.whitehouse.gov/news/releases/2008/03/
20080301.html.
---------------------------------------------------------------------------
2. Lack of effective controls over prescribed controlled substances
distributed by rogue Internet pharmacies
Although many online pharmacies are legitimate businesses
that offer safe and convenient services similar to those
provided by traditional neighborhood pharmacies and large chain
drugstores, other online pharmacies, often referred to as
``rogue sites,'' engage in the illegal practices of
distributing controlled substances without prescriptions or
using a truncated prescription process so flawed that medical
authorities reject it.\9\
---------------------------------------------------------------------------
\9\``You've Got Drugs!'' IV: Prescription Drug Pushers on the
Internet, Nat'l Ctr on Addiction & Substance Abuse (CASA) at Columbia
Univ., May 2007, at 7 [hereinafter You've Got Drugs IV] (``The
Federation of State Medical Boards of the United States, Inc., the
American Medical Association, the National Association of Boards of
Pharmacy, and the Drug Enforcement Administration (DEA) all agree that
online consultations cannot take the place of a face-to-face physical
examination with a legitimate physician.''), available at http://
www.casacolumbia.org/absolutenm/articlefiles/380-
2007%20You've%20Got%20Drugs%20IV.pdf.
---------------------------------------------------------------------------
Mr. Rannazzisi testified that the Internet has created a
new marketplace and delivery system for drug traffickers. Mr.
Rannazzisi called the Internet a ``perfect medium'' for the
sale of illicit drugs, connecting people from anywhere around
the world at any time and cloaking them in anonymity, and said
that the Internet allows for a more rapid means of diverting
large quantities of controlled substances.\10\
---------------------------------------------------------------------------
\10\Rogue Online Pharmacies Hearing, supra note 2 (testimony of
Joseph T. Rannazzisi).
---------------------------------------------------------------------------
Indeed, many rogue Internet pharmacies appear to have been
set up for the very purpose of promoting large sales of
controlled substances. According to Mr. Rannazzisi, in 2006, 34
known or suspected rogue Internet pharmacies dispensed
98,566,711 dosages of hydrocodone combination products.\11\
These 34 pharmacies alone dispensed enough hydrocodone
combination products to supply 410,000 actual patients with a
one-month supply at the maximum amount recommended per
prescription. Mr. Rannazzisi said that a typical, traditional,
independent brick and mortar pharmacy sells about 180
prescriptions per day. Of these sales, only 11 percent involved
controlled substances. However, the typical online pharmacy
sells around 450 prescriptions each day--425 of these sales, or
95 percent, involve controlled substances.\12\
---------------------------------------------------------------------------
\11\Id.
\12\Id.
---------------------------------------------------------------------------
Unfortunately, the number of rogue Internet sites only has
grown. In CASA's fourth annual report on this topic, entitled
You've Got Drugs! IV: Prescription Drug Pushers on the
Internet, it found that from 2006 to 2007 there had been:
A 70 percent increase in the number of
websites advertising or selling controlled prescription
drugs, from 342 to 581;\13\
---------------------------------------------------------------------------
\13\You've Got Drugs IV, supra note 9, at 4.
---------------------------------------------------------------------------
A 135 percent increase in the number of
websites advertising prescription controlled
substances, from 168 to 394;\14\
---------------------------------------------------------------------------
\14\Id. at 5.
---------------------------------------------------------------------------
A seven percent increase in the number of
websites selling prescription controlled substances,
from 174 to 187 (between 2004 and 2007, the number
websites selling prescription controlled substances
rose steadily from 154 in 2004 to 187 in 2007);\15\
---------------------------------------------------------------------------
\15\Id.
---------------------------------------------------------------------------
Eighty-four percent of the websites selling
prescription controlled substances do not require a
prescription from the patient's physician;\16\ and
---------------------------------------------------------------------------
\16\Id.
---------------------------------------------------------------------------
No controls to stop the sale of these drugs
to children.\17\
---------------------------------------------------------------------------
\17\Id. at 7.
---------------------------------------------------------------------------
The current mechanism for certifying Internet pharmacy
practice is purely voluntary.\18\ Of the 187 selling sites
identified by CASA in 2007, only two were certified by Verified
Internet Pharmacy Practice SitesTM (VIPPS).\19\
Most often, according to Mr. Califano, ``Online purchase of
controlled prescription drugs happens beneath the radar screens
of Internet providers, financial institutions, shippers and
parents.''\20\
---------------------------------------------------------------------------
\18\Verified Internet Pharmacy Practice SitesTM
(VIPPS), Nat'l Ass'n. of Bds. of Pharmacy, available at http://
www.nabp.net/index.html?target=/vipps/intro.asp&.
\19\Verified Internet Pharmacy Practice SitesTM
(VIPPS), http://www.nabp.net/ (last visited Oct. 16, 2007) (the
National Association of Boards of Pharmacy reported that 13 pharmacies
had received VIPPS certification as of Oct. 16, 2007).
\20\Rogue Online Pharmacies Hearing, supra note 2 (testimony of
Joseph A. Califano).
---------------------------------------------------------------------------
A recent study by the British Broadcasting Corporation
(BBC) revealed the wide scope of rogue Internet pharmacies
operating worldwide.\21\ The BBC sought to identify all of the
websites selling six popular prescription drugs online. In
total, the BBC identified 3,160 online pharmacies. The number
of the websites offering prescription controlled substances was
not identified, but controls were clearly lacking--many
websites advertised the fact that no prescription was required
to buy medicines, and only four had VIPPS accreditation.
According to the BBC, many of the websites falsely claimed
VIPPS accreditation, and half of the websites did not
safeguard customer details. The websites were also heavily
trafficked--the websites averaged 32,000 visitors daily, which
could equate to 2 billion in annual sales for the
six drugs examined by the BBC study.\22\
---------------------------------------------------------------------------
\21\Drug Website Safety Fears Raised, BBC News, Aug. 19, 2007,
http://news.bbc.co.uk/2/hi/health/6951254.stm.
\22\Id.
---------------------------------------------------------------------------
In short, at a minimum, ``[t]ens of thousands of
`prescriptions' are written each year for controlled and non-
controlled prescription drugs through such Internet pharmacies,
which do not require medical records, examinations, lab tests
or follow-ups.''\23\
---------------------------------------------------------------------------
\23\You've Got Drugs IV, supra note 9, at 7.
---------------------------------------------------------------------------
Mr. Rannazzisi testified that the problem extends beyond
Internet sales.\24\ The sheer volume of prescription controlled
substances being dispensed anonymously over the Internet also
contributes significantly to other downstream methods of
diversion, like children and young adults who obtain
prescription controlled substances from the family medicine
cabinet or other family and friends. Mr. Rannazzisi said that
when these downstream individuals obtain these substances, they
generally acquire only a few pills at a time. In contrast,
individuals ordering over the Internet frequently receive 100-
120 pills at a time, making the Internet purchaser a
potentially much higher-volume source for friends and family
than the family medicine cabinet.\25\
---------------------------------------------------------------------------
\24\Rogue Online Pharmacies Hearing, supra note 2 (testimony of
Joseph T. Rannazzisi).
\25\Id.
---------------------------------------------------------------------------
3. Disastrous consequences
Ease of access to the Internet, combined with lack of
medical supervision, has led to tragic consequences in the
online purchase of prescription controlled substances. News
reports continue to document the growing list of examples:
In 1999, an autopsy of 43-year-old Juris Abolins
identified traces of OxyContin and diazepam (generic Valium).
Relatives also found a bottle of Tussionex, a cough suppressant
containing hydrocodone, which Abolins had purchased from a
website based in Texas. Abolins had told friends he was
suffering from kidney stones, but an autopsy found no evidence
of this condition.\26\
---------------------------------------------------------------------------
\26\The Victims, Washington Post, Oct. 21, 2003, at A15, available
at http://www.washingtonpost.com/wp-dyn/content/article/2007/06/28/
AR2007062801388.html.
---------------------------------------------------------------------------
In September 2001, Douglas Townsend of South
Carolina died after driving his car into a fence. His family
said he took a generic form of the tranquilizer Xanax, which he
purchased from myprivatedoc.com, a now-defunct website based in
Mesa, Arizona.\27\
---------------------------------------------------------------------------
\27\Id.
---------------------------------------------------------------------------
In April 2003, Elizabeth Carr found her 47-year-
old husband and former triathlete, James Lewis, dead on their
living room couch. An autopsy found excessive amounts of the
painkiller Darvon, purchased through Internet pharmacies based
in South Africa, Thailand, and Vietnam.\28\
---------------------------------------------------------------------------
\28\Id.
---------------------------------------------------------------------------
In July 2003, 33-year-old mother Sandra M. Waltz
died of an overdose of Soma and generic Darvon. Her family
discovered that she had ordered drugs from a computer at her
workplace.\29\
---------------------------------------------------------------------------
\29\Id.
---------------------------------------------------------------------------
In December 2003, 19-year-old Jason Surks died of
an accidental overdose of Xanax, which he had been buying along
with OxyContin over the Internet.\30\
---------------------------------------------------------------------------
\30\Vincent Todaro, Center to memorialize local overdose victim
Jason Surks, 19, died last year due to his abuse of prescription drugs,
The Sentinel, Aug. 19, 2004; see also Linda Surks, A Lethal
Prescription, Partnership for a Drug-Free America (May 18, 2006),
http://www.drugfree.org/Portal/Memorials/A_Lethal_Prescription.
---------------------------------------------------------------------------
In December 2003, Robin Bartlett of Florida died
from complications of drug overuse after receiving 4,000 doses
of prescription drugs, including Schedule II narcotics like
hydrocodone, that were purchased over the Internet over a
period of just 3\1/2\ months. After she died, her husband
continued to get messages from Internet-based distributors,
asking why his wife had not reordered more controlled
substances.\31\
---------------------------------------------------------------------------
\31\Thomas Tryon, Wife's death leads husband to sue Internet
prescription purveyors, Sarasota Herald-Tribune, Oct. 16, 2005, at F1.
---------------------------------------------------------------------------
In April 2004, 30-year-old plastics salesman Craig
Schmidt suffered brain damage and nearly died after taking the
anxiety drug Xanax and the painkiller Ultram, both of which he
had purchased over the Internet. Schmidt reasoned that
``spending $400 for brand-name drugs like Xanax and Ultram
simply seemed easier and more discreet than visiting a
doctor.'' But three weeks after taking tablets containing 2mg
of Xanax (quadruple the typical initial dosage a physician
would normally prescribe) he awoke in a Chicago hospital room
with hypoxic encephalopathy--widespread brain damage.\32\
---------------------------------------------------------------------------
\32\Keith Epstein, The Deadly Side Effects of Net Pharmacies,
Business Week, Dec. 18, 2006, available at http://www.businessweek.com/
magazine/content/06_51/b4014070.htm; see also Abdon M. Pallasch, Man
Sues Over Online Prescription, Chicago Sun-Times, Jan. 10, 2006, at 8.
---------------------------------------------------------------------------
In 2006, Justin Pearson of St. Cloud, Minnesota
died on Christmas Day of an overdose after receiving at least
12 shipments of drugs purchased over the Internet. The man who
sold Pearson and others controlled substances made $24 million
before he was stopped, even though at least two other people
had also died within 18 months of buying such drugs.\33\
---------------------------------------------------------------------------
\33\David Unze, Internet Operation Puts Man in Prison, St. Cloud
Times, Aug. 3, 2007, at 1B.
---------------------------------------------------------------------------
4. Demonstrated need for a federal legislative solution
The DOJ recognizes the need for legislation to address the
Internet-based pharmacy problem. During a July 2006 Department
of Justice oversight hearing before this Committee, Attorney
General Gonzales testified that the sale of pharmaceuticals
over the Internet was a great concern and that rogue Internet
pharmacies gave drug abusers the ability to obtain controlled
substances and circumvent the law, as well as sound medical
practice. The Attorney General testimony noted that because the
websites associated with these online pharmacies either posted
no identifying information or simply gave false information, it
was difficult for law enforcement to track any of the
individuals behind the websites. The Attorney General also
noted that the DOJ was using all available tools to investigate
and shut down rogue Internet pharmacies, but left no doubt of
the difficulties law enforcement was facing in these
investigations.\34\
---------------------------------------------------------------------------
\34\Department of Justice Oversight: Hearing Before the S. Comm. on
the Judiciary, 110th Cong. (July 18, 2006) (statement of Alberto
Gonzales, former Att'y Gen. of the United States).
---------------------------------------------------------------------------
In January 2007, Attorney General Gonzales testified that
problems with the illegal sale of prescription drugs over the
Internet remained and that increased enforcement efforts were
simply not enough. Mr. Gonzales indicated that the DOJ looked
forward to working with Congress to enact additional
enforcement tools to address the problem.\35\
---------------------------------------------------------------------------
\35\Jan. 2007 DOJ Hearing, supra note 1; see also, Apr. 2007 DOJ
Oversight, supra note 7.
---------------------------------------------------------------------------
In responses to written follow-up questions, Mr. Gonzales
explained that Internet technology had outpaced the enforcement
scheme set forth in the 1970 Controlled Substances Act, which
was enacted many years before the development and widespread
use of the Internet.\36\ Mr. Gonzales stated that the evolution
of Internet technology had created a haven for individuals to
operate rogue Internet pharmacies anonymously. Noting that
currently no statutory definition of a valid doctor/patient
relationship existed, Mr. Gonzales's testimony indicated that
additional statutory clarification relating to the sale of
controlled substances over the Internet would allow law
enforcement to more readily distinguish between legitimate and
rogue online pharmacies, and would also help in gathering
information pointing to drug abuse patterns.\37\
---------------------------------------------------------------------------
\36\Jan. 2007 DOJ Hearing, supra note 1, at 12.
\37\Id.
---------------------------------------------------------------------------
Mr. Gonzales also testified that the statutory penalties
associated with the sale of Schedule III-V controlled
substances, the most common controlled substances sold over the
Internet, were too lenient.\38\ In later testimony before the
Committee, Mr. Rannazzisi also singled out Schedule III and IV
controlled substances, including hydrocodone combination
products and anabolic steroids, as ``increasingly accessible
and often illegally purchased through the Internet.''\39\
---------------------------------------------------------------------------
\38\Id.
\39\Rogue Online Pharmacies Hearing, supra note 2 (testimony of
Joseph T. Rannazzisi).
---------------------------------------------------------------------------
On March 1, 2008, in his national radio address, President
George W. Bush called on Congress to enact legislation to
address rogue Internet pharmacies.\40\ While noting that
legitimate Internet pharmacies provide substantial benefits,
the President said that the Internet has created the
opportunity for unscrupulous doctors and pharmacists to profit
from addiction. The President specifically mentioned Ryan
Haight, for whom the bill is named, who died of an overdose of
pain killers that were illegally prescribed over the Internet,
and called on Congress to pass legislation to end the illegal
sale of prescription drugs over the Internet.\41\
---------------------------------------------------------------------------
\40\Bush Radio Address, supra note 8.
\41\Id.
---------------------------------------------------------------------------
Other groups have also called on Congress to enact
legislation to address this problem. For example, CASA has
noted that the lack of clarity in Federal and State law over
what constitutes a legitimate prescription and has stated that
enforcement efforts on the part of law enforcement to address
rogue Internet websites have been hampered by the lack of clear
legislation on the issue.\42\ CASA further concluded that
because the Internet transcends State lines, Federal action is
essential to address rogue Internet pharmacies.\43\
---------------------------------------------------------------------------
\42\You've Got Drugs IV, supra note 9, at 3.
\43\Id. at 8.
---------------------------------------------------------------------------
The bill has received endorsements from law enforcement
organizations such as the Fraternal Order of Police and the
National Narcotics Officers' Associations Coalition, from
industry representatives such as the Healthcare Distribution
Management Association, AmerisourceBergen Corporation, eBay
Inc., and GoDaddy.com, and from the Federation of State Medical
Boards.
II. History of the Bill and Committee Consideration
A. INTRODUCTION OF THE BILL
Senators Feinstein and Sessions introduced S. 980, the
Online Pharmacy Consumer Protection Act of 2007, on March 23,
2007. The bill was referred to the Senate Committee on the
Judiciary. Following the introduction of S. 980, Senators
Biden, Coleman, Leahy and Cornyn joined as cosponsors of this
legislation.
B. COMMITTEE CONSIDERATION
On May 16, 2007, the Judiciary Committee held a hearing
entitled, ``Rogue Online Pharmacies: The Growing Problem of
Internet Drug Trafficking.''\44\ Witnesses at the hearing
included: (1) Francine Haight of Laguna Niguel, California,
Founder of Ryan's Cause; (2) Joseph T. Rannazzisi, Deputy
Assistant Administrator of the Office of Diversion Control at
the U.S. Drug Enforcement Administration; (3) Joseph A.
Califano, Jr., Chairman and President of the National Center on
Addiction and Substance Abuse at Columbia University (and
former U.S. Secretary of Health, Education and Welfare); (4) A.
Thomas McLellan, Ph.D., Executive Director of the Treatment
Research Institute at the University of Pennsylvania; and (5)
Philip Heymann, the James Barr Ames Professor of Law at Harvard
Law School (and former U.S. Deputy Attorney General).
---------------------------------------------------------------------------
\44\Rogue Online Pharmacies Hearing, supra note 2 (testimony of
Joseph A. Califano).
---------------------------------------------------------------------------
During the hearing, Ms. Haight testified about her son
Ryan, who died from an overdose of controlled substances that
he ordered over the Internet at age 17.\45\ Ryan, described as
``the boy next door,'' was an honor student who maintained an
academic average of at least 4.0 throughout high school, and a
varsity athlete. Ryan also was computer savvy and was
considering a possible career in computers after college. On
February 12, 2001, Ryan's mother found him in bed, lifeless.
Later analysis established an overdose of Vicodin, with traces
of Valium and Morphine. His family did not know how Ryan had
obtained such drugs until a friend of Ryan said he had bought
them over the Internet. After examining Ryan's computer, the
Haights learned that a doctor Ryan had never seen prescribed
the medications, and an online pharmacy had delivered them to
him at home. Ms. Haight testified, ``We did not know that drug
dealers were in our own family room.'' Six years after the
tragedy, Ms. Haight said that little has changed: ``I am still
shocked at the ease and availability of buying controlled
substances on the Internet. I still receive emails to purchase
drugs daily.'' She concluded: ``Tighter controls on the sale of
controlled substances on the Internet will not totally solve
the drug problem, but I guarantee it will help and it's a good
place to start.''\46\
---------------------------------------------------------------------------
\45\Rogue Online Pharmacies Hearing, supra note 2 (testimony of
Francine Haight, Founder, Ryan's Cause).
\46\Id.
---------------------------------------------------------------------------
Mr. Rannazzisi testified about the methods historically
used by many rogue Internet pharmacies, and named three primary
facilitators of illegal pharmaceutical sales--the doctor, the
pharmacy, and the Internet facilitator.\47\ His testimony noted
that these sales are promoted by Internet facilitators who lack
medical training and are not DEA registrants and that these
facilitators target doctors with significant debt and convince
them to approve prescriptions because prospective Internet
clients submit minimum ``medical history'' forms through the
website.\48\ Mr. Rannazzisi testified that such doctors approve
prescriptions for Schedule III or IV controlled substances with
the mistaken belief or justification that these substances are
not as dangerous as those listed in Schedule II.\49\ According
to Mr. Rannazzisi, for every online prescription that doctors
authorize, the Internet facilitator pays the doctor $10 to $25,
and law enforcement has discovered website-affiliated
physicians who authorized hundreds of online prescriptions a
day.\50\
---------------------------------------------------------------------------
\47\Rogue Online Pharmacies Hearing, supra note 2 (testimony of
Joseph T. Rannazzisi).
\48\Id.
\49\Id.
\50\Id. See also You've Got Drugs IV, supra note 9, at 7 (The
National Center on Addiction and Substance Abuse calls such physicians
``script doctors,'' who ``are willing to write prescriptions for a
fee.'' It has identified some fees for certain prescriptions as high as
$180); and Epstein, supra note 32 (noting that an ``accomplished''
doctor of this type, as the hired hand of an online pharmacy,
``typically approves Internet prescriptions at a rate of more than
1,000 a day--without communicating with the purchaser, or in many
cases, reading the questionnaire.'' It estimates that ``[a]n ambitious
doctor [of this type] can earn over $1 million a year.''). See also
http://sid.senate.gov/dana/home/
launch.cgi?url=http%3A%2F%2Fwww.congress.gov%2F (Unfortunately, as the
Congressional Research Service notes, ``laws governing medical practice
vary widely in strength and effectiveness from State to State. While
some states have strong laws that explicitly prohibit activities such
as prescribing drugs without conducting an in-person examination, other
states have weak laws, lax enforcement, or both.'')
---------------------------------------------------------------------------
Mr. Rannazzisi testified that Internet facilitators also
recruit brick and mortar pharmacies into their online schemes,
often targeting small, independent pharmacies struggling to
make ends meet.\51\ According to the DEA, the Internet
facilitator tells these pharmacies that all they have to do is
fill and ship these prescriptions to customers. In addition to
paying the pharmacy for the cost of the prescription, the
Internet facilitator also pays the pharmacy a negotiated fee,
sometimes amounting to millions of dollars.
---------------------------------------------------------------------------
\51\Rogue Online Pharmacies Hearing, supra note 2 (testimony of
Joseph T. Rannazzisi).
---------------------------------------------------------------------------
Mr. Rannazzisi also testified that Internet facilitators
host the websites that draw online customers into the rogue
Internet pharmacy scheme. According to Mr. Rannazzisi, these
websites often mislead customers by advertising the website as
an actual pharmacy. In reality, the rogue Internet websites
offer only a few pharmaceutical products for sale, typically
limited to prescription controlled substances and lifestyle
drugs. Mr. Rannazzisi testified that website advertising
typically emphasizes the ability of online customers to acquire
controlled substances without prescription or an appropriate
medical examination, and none of the rogue Internet pharmacies
require an in-person medical examination from a licensed
physician. He also testified that rogue Internet pharmacy
websites rarely contain any identifying information on the
website about where the pharmacy is physically located or who
owns and operates it.\52\
---------------------------------------------------------------------------
\52\Id.
---------------------------------------------------------------------------
In addition, Mr. Rannazzisi's testimony highlighted how
customers of rogue Internet pharmacies obtain prescription
controlled substances online. Typically, customers simply
filled out a medical questionnaire, without any meaningful
interaction between a doctor and the customer. In many cases,
the questionnaire simply is a ruse created to identify exactly
what type of prescription controlled substance the customer
wants to purchase. In some cases, such website questionnaires
will not permit the customer to continue until specific
information justifying the purchase of a particular
prescription controlled substance is entered.\53\
---------------------------------------------------------------------------
\53\Id.
---------------------------------------------------------------------------
Mr. Rannazzisi also noted that prescription controlled
substances in the United States are legitimately prescribed and
dispensed within a closed system of distribution. With rogue
Internet pharmacies, however, complicity exist among all of the
participants, effectively eliminating all of the normal checks
and balances. While acknowledging that rogue sites outside of
the United States may prove more difficult to regulate, Mr.
Rannazzisi testified that the ``DEA believes a majority of the
rogue sites operating today are based in the United States and
work in concert with unscrupulous doctors and pharmacies.''
Other evidence indicated that offshore and foreign rogue sites
are also a very significant problem.\54\
---------------------------------------------------------------------------
\54\Id.
---------------------------------------------------------------------------
Mr. Califano testified that Federal enforcement efforts
aimed at illegal Internet drug trafficking was complicated by
outdated Federal law enacted before the advent of the
Internet.\55\ Given the widespread public health threat that
rogue Internet pharmacies posed, Mr. Califano called on
Congress to take action legislatively to clarify Federal law to
prohibit the sale or purchase of prescription controlled
substances on the Internet without a valid prescription, and to
require certification of online pharmacies to assure that they
meet rigorous standards of professional practice. Mr. Califano
specifically described S. 980 as an important ``step in the
right direction.''\56\
---------------------------------------------------------------------------
\55\Rogue Online Pharmacies Hearing, supra note 2 (testimony of
Joseph A. Califano).
\56\Id.
---------------------------------------------------------------------------
Dr. McLellan, whose Treatment Research Institute first
completed a study of this issue in 2004, testified that
``anyone--regardless of age or medical need can purchase
pharmaceutical grade opiates, barbiturates, benzodiazepines and
stimulants over the Internet without a prescription.''\57\
Despite intensive publicity in the past,\58\ Dr. McLellan
testified that nothing has changed and that it remains as easy
to buy prescription controlled substances online as it is to
buy a book or compact disc. He noted that while illicit drug
use by teens had dropped 23% over the past five years, new
users of prescription drugs have caught up with new users of
marijuana. Dr. McLellan blamed the increase in prescription
drug abusers on the rise of rogue Internet pharmacies. He
testified that ``Internet savvy teenagers with their own credit
cards or access to their parents' cards are increasingly
disposed to prescription drugs to get high.'' In particular,
Dr. McLellan singled out OxyContin and Vicodin--both in the
same family of drugs as heroin--as two drugs teenagers are
increasingly abusing. However, unlike heroin, OxyContin and
Vicodin are appropriate for pain management when prescribed and
taken under a physician's care, but are frequently available in
large quantities through unscrupulous doctors and rogue
Internet pharmacies.\59\
---------------------------------------------------------------------------
\57\Rogue Online Pharmacies Hearing, supra note 2 (statement of A.
Thomas McLellan, Ph.D., Executive Dir., Treatment Research Inst., Univ.
of Penn.).
\58\See, e.g., Gilbert M. Gaul and Mary Pat Flaherty, Doctors
Medicate Strangers on Web, Washington Post, Oct. 23, 2003, at A1.
\59\Rogue Online Pharmacies Hearing, supra note 2 (statement of A.
Thomas McLellan).
---------------------------------------------------------------------------
Dr. McClellan also discussed some of the more troubling
marketing principles of Internet pharmacies' websites--
including free or discounted first orders, shipments with no
identifying information, and even credit card billings for drug
orders made to look like charged ``ring tones'' for a student's
cellular phone. While deferring to others on the proper policy
response, Dr. McLellan testified:
[We] should do all in our power to put it out of the
reach of children. . . . for the majority of people in
this country suffering from addiction, the roots of the
disease can be traced to adolescence. More than 95% of
people who are dependent on alcohol or other drugs
started before they were 20 years old.\60\
---------------------------------------------------------------------------
\60\Id.
Mr. Heymann testified that despite the public outcry
against rogue Internet pharmacies, nothing was being done
legislatively to stop the problem.\61\ In Mr. Heymann's view,
however, many rogue websites selling such narcotic painkillers
as OxyContin and Vicodin are located abroad and will not be
deterred by U.S. threats of increased penalties. Accordingly,
Mr. Heymann suggested broader legislative approaches, such as
Government funding of a private monitoring group, with immunity
granted to companies taking actions recommended by that group.
Other suggestions included legislation forcing Internet search
engines to place warning banners on all online pharmacy
websites, and efforts by Congress to enlist credit card
companies and banks in enforcement efforts.\62\ Mr. Heymann
noted that his suggestions arose after six plenary meetings at
Harvard Law School, which were attended by a collaboration of
affected parties, including leaders of companies that play key
roles in Internet commerce, banks, credit card companies and
private carriers.\63\ However, Mr. Heymann acknowledged that
``not all agreed with each of our recommendations'' that were
being suggested by the plenary group's 5-6 leaders. While
leading credit card companies and Internet service providers
did express general support for many of the plenary group's
ideas, their preference was for encouraging voluntary
compliance rather than legislative or regulatory mandates.
Several plenary participants, as well as several panelists at a
Judiciary Committee roundtable briefing held by the Internet
Drug Caucus Advisory Committee on June 22, expressed opposition
to adding these proposals to S. 980.
---------------------------------------------------------------------------
\61\Rogue Online Pharmacies Hearing, supra note 2 (statement of
Philip Heymann, James Barr Ames Professor of Law, Harvard Law School,
former U.S. Deputy Att'y Gen. of the United States).
\62\Id. (``[O]n receipt of information about illicit transactions
from independent monitoring groups or from their own internal monitors,
the financial institutions would and should be expected to identify the
accounts that are being abused, presumably by putting through a `test'
order of their own. The drug merchant's bank would be contractually
obligated to know its customer and to take steps to penetrate any
pseudonyms used by the drug dealer. The dealer's merchant bank would
also cut off credit to the offending account and to those behind the
account if it is really a front--furnishing the information it learns
about the illegal transaction to other credit card companies and to law
enforcement.'').
\63\``KeepInternetNeighborhoodsSafe'':AProposalforPreventingthe
1AIllegal Internet Sales of Controlled Substances to Minors, Harvard
Law School Internat'l Ctr. for Criminal Justice, July 13th, 2006,
available at http://www.law.harvard.edu/programs/criminal-justice/kins-
draft.pdf.
---------------------------------------------------------------------------
In addition to the hearing before the Senate Judiciary
Committee in the 110th Congress, other congressional hearings
have also examined problems of rogue Internet pharmacies,
providing background for this legislation. For example, the
Permanent Subcommittee on Investigations of the Senate's
Committee on Homeland Security and Governmental Affairs held a
hearing on June 17, 2004, following the issuance of a
Government Accountability Office report that documented the
ease with which prescription drugs, including addictive
narcotic pain killers, could be purchased over the Internet
without a prescription.\64\ On March 27, 2003 and March 18,
2004, the House of Representatives' Committee on Government
Reform also held hearings at which the FDA's Associate
Commissioner for Policy and Planning discussed illegal Internet
sales of controlled substances.\65\
---------------------------------------------------------------------------
\64\Buyer Beware: The Danger of Purchasing Pharmaceuticals over the
Internet--Day 2 Federal and Private Sector Responses: Hearing Before
the Permanent Subcommittee on Investigations, S. Comm. on Homeland
Security and Governmental Affairs 108th Cong., (2004); U.S. Gen.
Accounting Office, Internet Pharmacies: Some Pose Safety Risks for
Consumers and Are Unreliable in Their Business Practices (2004),
available at http://www.gao.gov/new.items/d04888t.pdf.
\65\Hearings Before the H. Comm. on Gov't Reform on Internet Drug
Sales, 108th Cong. (2003, 2004) (testimony of William K. Hubbard,
Assoc. Comm'r for Policy and Planning, Food and Drug Admin., Dep't of
Health and Human Servs.).
---------------------------------------------------------------------------
Chairman Leahy placed S. 980 on the Committee's executive
business meeting agenda for consideration on September 20,
2007, and the bill was considered by the Committee on that same
day. Senator Feinstein introduced an amendment in the nature of
a substitute to the original bill which was adopted by the
Committee. In addition to making various substantive changes,
the substitute named the bill in honor of Ryan Haight. The
Committee, by voice vote, reported the Ryan Haight Online
Pharmacy Consumer Protection Act of 2007, with an amendment in
the nature of a substitute, favorably to the full Senate.
III. Section-by-Section Summary of the Bill
Section 1. Short title
This section provides that the legislation may be cited as
the ``Ryan Haight Online Pharmacy Consumer Protection Act of
2007,'' in honor of Ryan Haight, a California high school
honors student and athlete who died in 2001 from an overdose of
controlled substances that he had purchased from a rogue online
pharmacy.
Section 2. Requirement of a valid prescription for controlled
substances dispensed by means of the Internet
This section adds a new subsection to section 309 of the
Controlled Substances Act that requires a ``valid
prescription'' for dispensing a controlled substance over the
Internet. A ``valid prescription'' is defined as one issued for
a legitimate medical purpose in the usual course of
professional practice, by a practitioner who has conducted at
least one in-person medical evaluation of the patient, or a
covering practitioner (as requested by a practitioner who had
conducted an in-person medical evaluation of the patient within
the past 24 months). Certain telemedicine practices are
exempted from the in-person medical evaluation requirement.
The Committee recognizes that telemedicine is a practice
tool that can improve health outcomes and reduce costs. It is
not the intent of the Committee to restrict the legitimate
practice of telemedicine or the emerging practices of
telemedicine which are consistent with medical practice
guidelines of the State in which the practitioner is licensed,
provided such practices do not contravene the goal of
effectively controlling the diversion of controlled substances.
The Committee recognizes that telemedicine offers options
for specialty and primary care not available in many remote
areas, and that practitioners with prescriptive authority are
often not available on-site at the time of tele-consultations.
It is not the intent of the Committee to place unnecessary
restrictions on the operations or growth of telemedicine
organizations that both conduct telemedicine consultations and
provide Internet prescription services to its patients.
Accordingly, the statute provides that the Attorney General
and the Secretary of Health and Human Services may promulgate
regulations that allow for the full practice of telemedicine
consistent with medical practice guidelines, so long as those
regulations continue to effectively control diversion. The
Committee anticipates that the Attorney General and the
Secretary may update these regulations on an ongoing basis to
reflect changes in telemedicine.
The legislation is intended to regulate practices related
to the delivery, distribution, or dispensing of schedule II,
III, IV, and V controlled substances by means of the Internet.
The bill does not address the delivery, distribution, or
dispensing of any non-controlled substance by means of the
Internet or any other means. The bill is not intended to
infringe upon the powers of the Department of Health and Human
Services and its Secretary with respect to non-controlled
substances. Nor is it intended to infringe upon the traditional
power of the States to regulate the practices of medicine and
pharmacy with respect to the prescription of non-controlled
substances. It is not the intent of the Committee to affect the
delivery, distribution, or dispensing of non-controlled
substances, approved by the Secretary of Health and Human
Services or the regulatory bodies of the States, by means of
the legislation.
Section 3. Amendments to the Controlled Substances Act
This section makes a number of changes to the Controlled
Substances Act:
Section 3(a)--Definitions
This subsection defines ``Internet'', ``deliver,
distribute, or dispense by means of the Internet'', ``online
pharmacy,'' and ``practice of telemedicine.'' It also exempts
from the definition of an ``online pharmacy'' non-pharmacy
practitioners and mere advertisements that do not attempt to
facilitate an actual transaction.
It is not the intent of the Committee, in paragraph
(55)(B), to prohibit a licensed pharmacist, acting pursuant to
a patient's request via the Internet, and in the usual course
of professional practice, from contacting the patient's
prescriber and receiving an order for a new prescription for a
previously prescribed controlled substance that has expired or
has no remaining valid refills. Similarly, as a general rule,
it is not the intent of the Committee, in paragraphs (56)(A),
(B), and (C) to prohibit a pharmacist from contacting a
practitioner under all the circumstances described in either
paragraph (55) or (56). The lone exception is that a
practitioner, acting in the usual course of professional
practice and for a legitimate medical purpose, can direct the
pharmacist that the patient should be prescribed a different
controlled substance and specify the new prescription, provided
that the pharmacist subsequently contacts the patient by
telephone or in person to notify the patient of the
practitioner's change in prescription and provides appropriate
information and instructions to the patient regarding the
change in medication.
Therefore, it is the intent of the Committee that the
modified registration, reporting, and website posting
requirements applicable to online pharmacies would not apply to
DEA-registered pharmacies whose Internet business consists
solely of permitting consumers to use the pharmacy's Internet
site to order refills in the scenarios described above.
Section 3(b)--Registration requirements
This subsection establishes that a pharmacy that seeks to
dispense controlled substances via the Internet must register
in accordance with regulations to be promulgated by the
Attorney General.
Section 3(c)--Reporting requirements
This subsection requires that online pharmacies must report
on substances dispensed in accordance with regulations to be
promulgated by the Attorney General.
Section 3(d)--Online pharmacy licensing and disclosure
requirement
This subsection requires that online pharmacies must
clearly display notification that they comply with certain
requirements set forth in the bill: Pharmacies must post
information regarding: name of the owner, owner's contact
information, list of states in which the pharmacy is licensed
to distribute prescription drugs or controlled substances, name
of the pharmacy, street address of the pharmacy, name and
degree of pharmacist in charge, contact information for
pharmacist in charge, and the name and contact information of
affiliated practitioners. Their websites must also post a
statement of compliance. Online pharmacies must also notify the
Attorney General and State boards of pharmacy 30 days before
they begin delivering, distributing, or dispensing a controlled
substance.
Section 3(e)--Increased penalties for illegal distribution
of schedules III-V controlled substances
This subsection increases the penalties for all illegal
distributions of Schedule III, IV and V controlled substances
(not just Internet sales). For Schedule III controlled
substances, the maximum penalties are increased to 10 years for
first offenders and 20 years for repeat offenders, and to 20
and 30 years, respectively, if death or serious bodily injury
results. For Schedule IV substances, the new penalties are 5
years for first offenders and 10 years for repeat offenders.
For Schedule V repeat offenders, the maximum penalty increases
to 6 years. Supervised release terms after imprisonment for a
Schedule V offense are also authorized for the first time.
Section 3(f)--Internet sales of controlled substances
This subsection clarifies that knowingly causing or
facilitating the delivery or dispensing of controlled
substances over the Internet in violation of this Act can be
prosecuted and penalized in the same manner as illegal hand-to-
hand drug sales. The subsection clarifies, however, that this
provision does not apply to persons who register and follow the
requirements of this Act, to those who merely advocate usage or
list pricing information but do not promote or facilitate an
actual transaction involving a controlled substance, or to
anyone providing telecommunications, Internet services, or
links to other websites unless they are acting in concert with
persons violating this Act.
Section 3(g)--Advertising controlled substances
This subsection clarifies that Internet sales of controlled
substances must follow the terms of this Act.
Section 3(h)--Injunctive relief
This subsection authorizes State attorneys general to file
civil lawsuits in Federal court against online pharmacies and
obtain nationwide relief if the residents of a State are
threatened or adversely affected by noncompliance, and the U.S.
Attorney General is notified in advance and also given a chance
to intervene in the case within 120 days.
Section 3(i)--Forfeiture
This subsection expands the scope of property subject to
civil forfeiture under Federal drug laws, to encompass ``any
property used, in any manner or part, to commit or to
facilitate the commission of a violation'' under titles II or
III of the Comprehensive Drug Abuse Prevention and Control Act.
Concerns have been expressed about the potential impact of
this provision upon responsible companies engaged in providing
Internet marketplaces, electronic payment services, or similar
e-commerce services whose property may be used without the
companies' knowledge and consent to commit the new criminal
offenses created by the bill to address illicit online
pharmacies. Since such offenses will necessarily involve use of
the Internet and likely will involve electronic payments, the
Committee thinks it prudent to spell out its intent as to how
this new authority should be used in this context.
The intent of section 3(i), as applied to online
pharmacies, is to authorize Federal civil forfeiture of non-
innocent owners' property that facilitates violations of the
new statutes created by the bill. In this manner, this
provision of the bill is intended to provide Federal law
enforcement with an additional tool to combat the proliferation
of Internet-based criminal operations that employ ever-changing
methods and technologies to deliberately distribute
pharmaceutical controlled substances without a sound medical
basis. This expanded civil forfeiture authority is necessary to
provide law enforcement with a more effective and rapid means
to bring to a halt the operation of such rogue Web sites, which
the bill is designed to prohibit.
However, section 3(i) is not intended to authorize
forfeiture of the property, including the computer equipment,
facilities or networks of legitimate Internet marketplace
companies or payment card systems that take reasonable
precautions against the illegal use of their property, do not
consent to such use, and, upon learning of any such use, do all
that reasonably can be expected under the circumstances to
terminate it. The Committee notes that responsible companies in
this sector have adopted strong policies against use of their
networks, websites, or services for illegal purposes, and have
cooperated with law enforcement when they learned that their
services were being abused for criminal purposes. The Committee
commends those companies and encourages them to maintain and
strengthen their anti-crime policies and their efforts to
prevent criminal use of their property.
The Committee is aware that many existing civil forfeiture
statutes authorize forfeiture of property that is involved in
or facilitates other violations of Federal law that may be
facilitated through the abuse of the Internet. This existing
authority has not had disruptive impact on legitimate Internet
marketplaces, payment card systems, or their legitimate
customers because it has been exercised carefully and prudently
to date, in accordance with internal controls intended to
prevent misuse. The Committee urges that such careful
enforcement continue in service of the dual goals of detecting
and preventing criminal use of the Internet and fostering the
healthy growth of legitimate e-commerce.
Section 3(j)--Import and Export Act
This subsection makes the same penalty changes to the
Import and Export Act that are being made to the Controlled
Substances Act, so that illegal imports and exports of
controlled substances will continue to receive the same
penalties as illegal domestic sales.
Section 3(k)--Effective date
This subsection clarifies that the Act will become
effective 60 days after enactment.
Section 3(l)--Regulations and guidelines
This subsection specifies that the Attorney General shall
promulgate regulations as necessary to effect the Act, and the
U.S. Sentencing Commission shall add or modify the Sentencing
Guidelines as warranted.
Section 3(m)--Report to Congress
This subsection establishes that the DEA, after consulting
with the State Department, must provide a report to Congress
within 180 days of the Act's enactment, and annually thereafter
for 2 years, describing the foreign supply chains and sources
of controlled substances illegally offered over the Internet,
and the efforts and strategies being used to confront these
challenges globally.\66\
---------------------------------------------------------------------------
\66\As CASA recommends, ``[T]he State Department should encourage
and assist foreign Governments to crack down on Internet sites
illegally selling controlled prescription drugs to U.S. citizens.''
---------------------------------------------------------------------------
IV. Congressional Budget Office Cost Estimate
The Committee sets forth, with respect to the bill, S. 980,
the following estimate and comparison prepared by the Director
of the Congressional Budget Office under section 402 of the
Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, October 25, 2007.
Hon. Patrick J. Leahy,
Chairman, Committee on the Judiciary,
U.S. Senate, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for S. 980, the Ryan Haight
Online Pharmacy Consumer Protection Act of 2007.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Mark
Grabowicz.
Sincerely,
Peter R. Orszag.
Enclosure.
S. 980--The Ryan Haight Online Pharmacy Consumer Protection Act
Summary: S. 980 would require businesses that distribute
controlled substances using the Internet to register with the
Drug Enforcement Administration (DEA). CBO estimates that
implementing S. 980 would have no significant net cost to the
Federal Government. Enacting the bill could affect direct
spending and revenues, but CBO estimates that any net effects
would not be significant.
S. 980 contains an intergovernmental mandate as defined in
the Unfunded Mandates Reform Act (UMRA) because it would
preempt certain State regulations governing controlled
substances that are manufactured, distributed, or dispensed via
the Internet. CBO estimates, however, that states would incur
few, if any, costs as a result of that preemption, and
therefore the costs to comply with the mandate would be well
below the threshold established in UMRA ($66 million in 2007,
adjusted annually for inflation).
The registration and reporting requirements and the
requirement of a valid prescription for Internet distribution
of controlled substances constitute private-sector mandates as
defined in UMRA. CBO estimates that the direct costs of those
mandates would not exceed the threshold established in UMRA
($131 million in 2007, adjusted annually for inflation).
Estimated cost to the Federal Government:
Spending subject to appropriation
S. 980 would establish new crimes and increase penalties
for activities relating to illegal use of controlled
substances. Because the bill would establish new offenses, the
government would be able to pursue cases that it otherwise
would not be able to prosecute. We expect that S. 980 would
apply to a relatively small number of offenders, however, so
any increase in costs for law enforcement, court proceedings,
or prison operations would not be significant. Any such costs
would be subject to the availability of appropriated funds.
Direct spending and revenues
S. 980 would require businesses that distribute controlled
substances using the Internet to register with the DEA. The DEA
would charge a registration fee of $551 for a three-year
period. Based on information from the DEA about the likely
number of new registrants, CBO estimates that the agency would
collect no more than a few million dollars each year. The DEA
would spend those fees without further appropriation, mostly in
the same year, to conduct inspections and carry out
administrative activities related to the new registrants. Thus,
CBO estimates that S. 980 would have no significant net effect
on DEA spending.
Because those prosecuted and convicted under S. 980 could
be subject to criminal fines, the Federal government might
collect additional fines if the legislation is enacted.
Criminal fines are recorded as revenues, then deposited in the
Crime Victims Fund, and later spent. CBO expects that any
additional revenues and direct spending would not be
significant because of the small number of cases likely to be
affected.
Estimated impact on State, local, and Tribal Governments:
S. 980 contains an intergovernmental mandate as defined in UMRA
because it would preempt certain State regulations of
controlled substances that are manufactured, distributed, or
dispensed via the Internet. Under current law, states license
pharmacies and doctors to dispense controlled substances within
each state. This bill would prohibit the sale of controlled
substances that are sold over the Internet without a
prescription and would require doctors to have at least one in-
person consultation with patients for whom they prescribe
controlled medications. Currently, all states allow medications
to be purchased via the Internet, but some states do not
specifically require in-person consultations for prescriptions.
Enacting this provision would preempt State authority. CBO
estimates, however, that states would incur few, if any, costs
as a result of that preemption, and therefore the costs to
comply with the mandate would be well below the threshold
established in UMRA ($66 million in 2007, adjusted annually for
inflation).
Estimated impact on the private sector: The registration
and reporting requirements and the requirement to have a valid
prescription for distributing controlled substances via the
Internet constitute private-sector mandates as defined in UMRA.
CBO estimates that the direct costs of those mandates would not
exceed the threshold established in UMRA ($131 million in 2007,
adjusted annually for inflation).
Estimate prepared by: Federal costs: Mark Grabowicz; Impact
on State, local, and Tribal Governments: Melissa Merrell;
Impact on the private sector: Colin Baker.
Estimate approved by: Theresa Gullo, Deputy Assistant
Director for Budget Analysis.
V. Regulatory Impact Evaluation
In compliance with paragraph 11(b)(1), rule XXVI of the
Standing Rules of the Senate, the Committee finds that the
passage of S. 980 will require the Department of Justice to
promulgate regulations governing the registration of, and
reporting requirements imposed on, online pharmacies that
dispense controlled substances by means of the Internet, and
may require the Department of Health and Human Services and the
Department of Justice to promulgate regulations governing
certain practices relating to the practice of telemedicine.
VI. Conclusion
The Congressional Research Service has stated:
The current legal framework for regulating online
pharmacies and doctors is a patchwork of Federal and
State laws regarding controlled substances,
prescription drugs, pharmacies, and the practice of
medicine. Although many doctors and pharmacies who use
the Internet prescribe and dispense drugs in a safe and
legal fashion, others have exploited gaps in the
current system to prescribe and dispense potentially
dangerous quantities of highly addictive prescription
drugs.\67\
---------------------------------------------------------------------------
\67\See Legal Issues Related to Prescription Drug Sales on the
Internet (RS21711, updated September 19, 2007) https://sid.senate.gov/
dana/home/launch.cgi?url=http%3A%2Fst%2F www.congress.gov%2F.
Passage and enactment of the bipartisan Ryan Haight Online
Pharmacy Consumer Protection Act of 2007, S. 980, will address
the intolerable ``wide-open channel of distribution'' that
currently exists for prescription controlled substances sold
over the Internet, which represents an ``easy availability
[that] has enormous implications for public health,
particularly the health of our children.''\68\ The Committee
believes that the time has come for Congress to act, and that
S. 980 is an appropriate response that should be adopted by
Congress.
---------------------------------------------------------------------------
\68\You've Got Drugs IV: Prescription Drug Pushers on the Internet,
at 8 (White Paper issued by the National Center on Addiction and
Substance Abuse at Columbia University, May 2007).
---------------------------------------------------------------------------
VII. Changes to Existing Law Made by the Bill, as Reported
In compliance with paragraph 12 of rule XXVI of the
Standing Rules of the Senate, changes in existing law made by
S. 980, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, and existing law in which no
change is proposed is shown in roman):
TITLE 21, UNITED STATES CODE
* * * * * * *
CHAPTER 13--DRUG ABUSE PREVENTION AND CONTROL
* * * * * * *
Subchapter I--Control and Enforcement
* * * * * * *
Part A--Introductory Provisions
* * * * * * *
Sec. 802. Definitions
As used in this subchapter:
(1) * * *
* * * * * * *
(50) The term ``Internet'' means collectively the
myriad of computer and telecommunications facilities,
including equipment and operating software, which
comprise the interconnected worldwide network of
networks that employ the Transmission Control Protocol/
Internet Protocol, or any predecessor or successor
protocol to such protocol, to communicate information
to all kinds by wire or radio.
(51) The term ``deliver, distribute, or dispense by
means of the Internet'' refers, respectively, to any
deliver, distribution, or dispensing of a controlled
substance that is caused or facilitated by means of the
Internet.
(52) The term ``online pharmacy''--
(A) means a person, entity, or Internet site,
whether in the United States or abroad, that
knowingly or intentionally delivers,
distributes, or dispenses, or offers or
attempts to deliver, distribute, or dispense, a
controlled substance by means of the Internet:
and
(B) does not include--
(i) manufacturers or distributors
registered under subsection (a), (b),
(c), or (d) of section 303 who do not
dispense controlled substances to an
unregistered individual or entity;
(ii) nonpharmacy practitioners who
are registered under section 303(f) and
whose activities are authorized by that
registration;
(iii) mere advertisements that do not
attempt to facilitate an actual
transaction involving a controlled
substance; or
(iv) a person, entity, or Internet
site which is not in the United States
and does not facilitate the delivery,
distribution, or dispensing of a
controlled substance by means of the
Internet to any person in the United
States.
(53) The term ``homepage'' means the opening or main
page or screen of the website of an online pharmacy
that is viewable on the Internet.
(54) The term ``practice of telemedicine'' means the
practice of medicine in accordance with applicable
Federal and State laws by a practitioner (other than a
pharmacist) who is at a location remote from the
patient and is communicating with the patient, or
health care professional who is treating the patient,
using a telecommunications system referred to in
section 1834(m) of the Social Security Act (42 U.S.C.
1395m(m)).
* * * * * * *
Part C--Registration of Manufacturers, Distributors, and Dispensers of
Controlled Substances
Sec. 823. Registration requirements
(a) * * *
* * * * * * *
(i) Dispenser of Controlled Substances by Means of the
Internet.--
(1) An online pharmacy shall obtain a registration
specifically authorizing such activity, in accordance
with regulations promulgated by the Attorney General.
In determining whether to grant an application for such
registration, the Attorney General shall apply the
factors set forth in subsection (f).
(2) Registration under this subsection shall be in
addition to, and not in lieu of, registration under
subsection (f).
(3) This subsection does not apply to pharmacies that
merely advertise by means of the Internet but do not
attempt to facilitate an actual transaction involving a
controlled substance by means of the Internet.
* * * * * * *
Sec. 827. Records and reports of registrants
(a) Inventory.--
* * * * * * *
(d) Periodic Reports to Attorney General.--
(1) Every manufacturer registered under section 823
of this title shall, at such time or times and in such
form as the Attorney General may require, make periodic
reports to the Attorney General of every sale, delivery
or other disposal by him of any controlled substance,
and each distributor shall make such reports with
respect to narcotic controlled substances, identifying
by the registration number assigned under this
subchapter the person or establishment (unless exempt
from registration under section 822(d) of this title)
to whom such sale, delivery, or other disposal was
made.
(2) A pharmacy registered under section 303(i) shall
report to the Attorney General the controlled
substances dispensed under such registration, in such
manner and accompanied by such information as the
Attorney General by regulation shall require.
* * * * * * *
Sec. 829. Prescriptions
(a) * * *
* * * * * * *
(e) Controlled Substances Dispensed by Means of the
Internet.--
(1) No controlled substance may be delivered,
distributed, or dispensed by means of the Internet
without a valid prescription.
(2) As used in this subsection:
(A) The term ``valid prescription'' means a
prescription that is issued for a legitimate
medical purpose in the usual course of
professional practice by--
(i) a practitioner who has conducted
at least one in-person medical
evaluation of the patient; or
(ii) a covering practitioner.
(B)(i) The term ``in-person medical
evaluation'' means a medical evaluation that is
conducted with the patient in the physical
presence of the practitioner, without regard to
whether portions of the evaluation are
conducted by other health professionals.
(ii) Nothing in the clause (i) shall be
construed to imply that one in-person medical
evaluation demonstrates that a prescription has
been issued for a legitimate medical purpose
within the usual course of professional
practice.
(C) The term ``covering practitioner'' means,
with respect to a patient, a practitioner who
conducts a medical evaluation (other than an
in-person medical evaluation) at the request of
a practitioner who--
(i) has conducted at least one in-
person medical evaluation of the
patient during the 24-month period
ending on the date of that medical
evaluation; and
(ii) is temporarily unavailable to
conduct the evaluation of the patient.
(3) Nothing in this subsection shall apply to--
(A) the delivery, distribution, or dispensing
of a controlled substance by a practitioner
engaged in the practice of telemedicine if--
(i) the telemedicine is being
conducted while the patient is being
treated by, and physically located in,
a hospital or clinic registered under
section 303(f), and the practitioner
conducting the practice of telemedicine
is registered under section 303(f) in
the State in which the patient is
located and is acting in the usual
course of professional practice and in
accordance with applicable State law;
(ii) the telemedicine is being
conducted while the patient is being
treated by, and in the physical
presence of, a practitioner registered
under section 303(f) who is acting in
the usual course of professional
practice, and the practitioner
conducting the practice of telemedicine
is registered under section 303(f) in
the State in which the patient is
located and is acting in the usual
course of professional practice and in
accordance with applicable State law;
or
(iii) the telemedicine is being
conducted under any other circumstances
that the Attorney General and the
Secretary have jointly, by regulation,
determined to be consistent with
effective controls against diversion
and otherwise consistent with the
public health and safety; or
(B) The dispensing or selling of a controlled
substance pursuant to the practices as
determined by the Attorney General by
regulation, which shall be consistent with
effective controls against diversion.
* * * * * * *
Sec. 830. Regulation of listed chemicals and certain machine
* * * * * * *
Sec. 831. Online pharmacy licensing and disclosure requirements
(a) In General.--An online pharmacy shall display in a
visible and clear manner on its homepage a statement that it
complies with the requirements of this section with respect to
the delivery or sale or offer for sale of controlled substances
and shall at all times display on the homepage of its Internet
site a declaration of compliance in accordance with this
section.
(b) Licensure.--Each online pharmacy shall comply with the
requirements of State law concerning the licensure of
pharmacies in each State from which it, and in each State to
which it, delivers, distributes, or dispenses or offers to
deliver, distribute, or dispense controlled substances by means
of the Internet.
(c) Compliance.--No online pharmacy or practitioner shall
deliver, distribute, or dispense by means of the Internet a
controlled substance without a valid prescription (as defined
in section 309(e)) and each online pharmacy shall comply with
all applicable requirements of Federal and State law.
(d) Internet Pharmacy Site Disclosure Information.--Each
online pharmacy site shall post in a visible and clear manner
on the homepage of its Internet site or on a page directly
linked from its homepage the following:
(1) The name of the owner, street address of the
online pharmacy's principal place of business,
telephone number, and email address.
(2) A list of the States in which the online
pharmacy, and any pharmacy which dispenses, delivers,
or distributes a controlled substance on behalf of the
online pharmacy, is licensed to dispense controlled
substances or prescription drugs and any applicable
license number.
(3) For each pharmacy identified on its license in
each State in which it is licensed to engage in the
practice of pharmacy and for each pharmacy which
dispenses or ships controlled substances on behalf of
the online pharmacy:
(A) The name of the pharmacy.
(B) The street address of the pharmacy.
(C) The name, professional degree, and
licensure of the pharmacist-in-charge.
(D) The telephone number at which the
pharmacist-in-charge can be contacted.
(E) A certification that each pharmacy which
dispenses or ships controlled substances on
behalf of the online pharmacy is registered
under this part to deliver, distribute, or
dispense by means of the Internet controlled
substances.
(4) The name, address, professional degree, and
licensure of practitioners who provide medical
consultations through the website for the purpose of
providing prescriptions.
(5) A telephone number or numbers at which the
practitioners described in paragraph (4) may be
contacted.
(6) The following statement, unless revised by the
Attorney General by regulation: This online pharmacy
will only dispense a controlled substance to a person
who has a valid prescription issued for a legitimate
medical purpose based upon a medical relationship with
a prescribing practitioner, which includes at least one
prior in-person medical evaluation. This online
pharmacy complies with section 309(e) of the Controlled
Substances Act (21 U.S.C. 829(e)).
(e) Notification.--(1) Thirty days prior to offering a
controlled substance for sale, delivery, distribution, or
dispensing, the online pharmacy shall notify the Attorney
General, in the form and manner as the Attorney General shall
determine, and the State boards of pharmacy in any States in
which the online pharmacy offers to sell, deliver, distribute,
or dispense controlled substances.
(2) The notification required under paragraph (1) shall
include--
(A) the information required to be posted on the
online pharmacy's Internet site under subsection (d)
and shall notify the Attorney General and the
applicable State boards of pharmacy, under penalty of
perjury, that the information disclosed on its Internet
site under to subsection (d) is true and accurate;
(B) the online pharmacy's Internet site address and a
certification that the online pharmacy shall notify the
Attorney General of any change in the address at least
30 days in advance; and
(C) the Drug Enforcement Administration registration
numbers of any pharmacies and practitioners referred to
in subsection (d), as applicable.
(3) An online pharmacy that is already operational as of
the effective date of this section, shall notify the Attorney
General and applicable State boards of pharmacy in accordance
with this subsection not later than 30 days after the effective
date of this section.
(f) Declaration of Compliance.--On and after the date on
which it makes the notification under subsection (e), each
online pharmacy shall display on the homepage of its Internet
site, in such form as the Attorney General shall by regulation
require, a declaration that it has made such notification to
the Attorney General.
(g) Reports.--Any statement, declaration, notification, or
disclosure required under this section shall be considered a
report required to be kept under this part.
* * * * * * *
Part D--Offenses and Penalties
Sec. 841. Prohibited acts A
(a) Unlawful Acts.--
* * * * * * *
(b) Penalties.--Except as otherwise provided in section
849, 859, 860, or 861 of this title, any person who violates
subsection (a) of this section shall be sentenced as follows:
(1)(A) * * *
* * * * * * *
(C) In the case of a controlled substance in schedule
I or II, gamma hydroxybutyric acid (including when
scheduled as an approved drug product for purposes of
section 3(a)(1)(B) of the Hillory J. Farias and
Samantha Reid Date-Rape Drug Prohibition Act of 2000),
or [1 gram of] flunitrazepam, except as provided in
subparagraphs (A), (B), and (D), such person shall be
sentenced to a term of imprisonment of not more than 20
years and if death or serious bodily injury results
from the use of such substance shall be sentenced to a
term of imprisonment of not less than twenty years or
more than life, a fine not to exceed the greater of
that authorized in accordance with the provisions of
title 18 or $1,000,000 if the defendant is an
individual or $5,000,000 if the defendant is other than
an individual, or both. If any person commits such a
violation after a prior conviction for a felony drug
offense has become final, such person shall be
sentenced to a term of imprisonment of not more than 30
years and if death or serious bodily injury results
from the use of such substance shall be sentenced to
life imprisonment, a fine not to exceed the greater of
twice that authorized in accordance with the provisions
of title 18 or $2,000,000 if the defendant is an
individual or $10,000,000 if the defendant is other
than an individual, or both. Notwithstanding section
3583 of title 18, any sentence imposing a term of
imprisonment under this paragraph shall, in the absence
of such a prior conviction, impose a term of supervised
release of at least 3 years in addition to such term of
imprisonment and shall, if there was such a prior
conviction, impose a term of supervised release of at
least 6 years in addition to such term of imprisonment.
Notwithstanding any other provision of law, the court
shall not place on probation or suspend the sentence of
any person sentenced under the provisions of this
subparagraph which provide for a mandatory term of
imprisonment if death or serious bodily injury results,
nor shall a person so sentenced be eligible for parole
during the term of such a sentence.
(D) In the case of less than 50 kilograms of
marihuana, except in the case of 50 or more marihuana
plants regardless of weight, 10 kilograms of hashish,
or one kilogram of hashish oil [or in the case of any
controlled substance in schedule III (other than gamma
hydroxybutyric acid), or 30 milligrams of
flunitrazepam], such person shall, except as provided
in paragraphs (4) and (5) of this subsection, be
sentenced to a term of imprisonment of not more than 5
years, a fine not to exceed the greater of that
authorized in accordance with the provisions of title
18 or $250,000 if the defendant is an individual or
$1,000,000 if the defendant is other than an
individual, or both. If any person commits such a
violation after a prior conviction for a felony drug
offense has become final, such person shall be
sentenced to a term of imprisonment of not more than 10
years, a fine not to exceed the greater of twice that
authorized in accordance with the provisions of title
18 or $500,000 if the defendant is an individual or
$2,000,000 if the defendant is other than an
individual, or both. Notwithstanding section 3583 of
title 18, any sentence imposing a term of imprisonment
under this paragraph shall, in the absence of such a
prior conviction, impose a term of supervised release
of at least 2 years in addition to such term of
imprisonment and shall, if there was such a prior
conviction, impose a term of supervised release of at
least 4 years in addition to such term of imprisonment.
(E)(i) In the case of any controlled substance in
schedule III, such person shall be sentenced to a term
of imprisonment of not more than 10 years and if death
or serious bodily injury results from the use of such
substance shall be sentenced to a term of imprisonment
of not more than 20 years, a fine not to exceed the
greater of that authorized in accordance with the
provisions of title 18, or $500,000 if the defendant is
an individual or $2,500,000 if the defendant is other
than an individual, or both.
(ii) If any person commits such a violation after a
prior conviction for a felony drug offense has become
final, such person shall be sentenced to a term of
imprisonment of not more than 20 years and if death or
serious bodily injury results from the use of such
substance shall be sentenced to a term of imprisonment
of not more than 30 years, a fine not to exceed the
greater of twice that authorized in accordance with the
provisions of title 18, or $1,000,000 if the defendant
is an individual or $5,000,000 if the defendant is
other than an individual, or both.
(iii) Any sentence imposing a term of imprisonment
under this subparagraph shall, in the absence of such a
prior conviction, impose a term of supervised release
of at least 2 years in addition to such term of
imprisonment and shall, if there was such a prior
conviction, impose a term of supervised release of at
least 4 years in addition to such term of imprisonment
(2) In the case of a controlled substance in schedule
IV, such person shall be sentenced to a term of
imprisonment of not more than [3 years] 5 years, a fine
not to exceed the greater of that authorized in
accordance with the provisions of title 18 or $250,000
if the defendant is an individual or $1,000,000 if the
defendant is other than an individual, or both. If any
person commits such a violation [after one or more
prior convictions of him for an offense punishable
under this paragraph, or for a felony under any other
provision of this subchapter or subchapter II of this
chapter or other law of a State, the United States, or
a foreign country relating to narcotic drugs,
marihuana, or depressant or stimulant substances, have
become final] after a prior conviction for a felony
drug offense has become final, such person shall be
sentenced to a term of imprisonment of not more than [6
years] 10 years, a fine not to exceed the greater of
twice that authorized in accordance with the provisions
of title 18 or $500,000 if the defendant is an
individual or $2,000,000 if the defendant is other than
an individual, or both. Any sentence imposing a term of
imprisonment under this paragraph shall, in the absence
of such a prior conviction, impose a term of supervised
release of at least one year in addition to such term
of imprisonment and shall, if there was such a prior
conviction, impose a term of supervised release of at
least 2 years in addition to such term of imprisonment.
(3) In the case of a controlled substance in schedule
V, such person shall be sentenced to a term of
imprisonment of not more than one year, a fine not to
exceed the greater of that authorized in accordance
with the provisions of title 18 or $100,000 if the
defendant is an individual or $250,000 if the defendant
is other than an individual, or both. If any person
commits such a violation [after one or more convictions
of him for an offense punishable under this paragraph,
or for a crime under any other provision of this
subchapter or subchapter II of this chapter or other
law of a State, the United States, or a foreign country
relating to narcotic drugs, marihuana, or depressant or
stimulant substances, have become final] after a prior
conviction for a felony drug offense has become final,
such person shall be sentenced to a term of
imprisonment of not more than [2 years] 6 years, a fine
not to exceed the greater of twice that authorized in
accordance with the provisions of title 18 or $200,000
if the defendant is an individual or $500,000 if the
defendant is other than an individual, or both. Any
sentence imposing a term of imprisonment under this
paragraph may, if there was a prior conviction, impose
a term of supervised release of not more than 1 year,
in addition to such term of imprisonment.
* * * * * * *
(h) Offenses Involving Dispensing of Controlled Substances
by Means of the Internet.--
(1) Except as authorized by this title, it shall be
unlawful for any person to knowingly or intentionally
cause or facilitate the delivery, distribution, or
dispensing by means of the Internet of a controlled
substance.
(2) Examples of activities that violate paragraph (1)
include, but are not limited to, knowingly or
intentionally--
(A) delivering, distributing, or dispensing a
controlled substance by means of the Internet
by a pharmacy not registered under section
303(i);
(B) writing a prescription for a controlled
substance for the purpose of delivery,
distribution, or dispensation by means of the
Internet in violation of subsection 309(e);
(C) serving as an agent, intermediary, or
other entity that causes the Internet to be
used to bring together a buyer and seller to
engage in the dispensing of a controlled
substance in a manner not authorized by
sections 303(i) or 309(e); and
(D) making a material false, fictitious, or
fraudulent statement or representation in the
submission to the Attorney General under
section 311.
(3)(A) This subsection does not apply to--
(i) the delivery, distribution, or
dispensation of controlled substances by
nonpractitioners to the extent authorized by
their registration under this title;
(ii) the placement on the Internet of
material that merely advocates the use of a
controlled substance or includes pricing
information without attempting to propose or
facilitate an actual transaction involving a
controlled substance; or
(iii) except as provided in subparagraph (B),
any activity that is limited to--
(I) the provision of a
telecommunications service, or of an
Internet access service or Internet
information location tool (as those
terms are defined in section 231 of the
Communications Act of 1934 (47 U.S.C.
231)); or
(II) the transmission, storage,
retrieval, hosting, formatting, or
translation (or any combination
thereof) of a communication, without
selection or alteration of the content
of the communication, except that
deletion of a particular communication
or material made by another person in a
manner consistent with section 230(c)
of the Communications Act of 1934 (47
U.S.C. 230(c)) shall not constitute
such selection or alteration of the
content of the communication.
(B) The exceptions under subclauses (I) and (II) of
subparagraph (A)(iii) shall not apply to a person
acting in concert with a person who violates subsection
(g)(1).
(4) Any person who knowingly or intentionally
violates this subsection shall be sentenced in
accordance with subsection (b) of this section.
* * * * * * *
Sec. 843. Prohibited acts C
(a) * * *
* * * * * * *
(c) Advertisement.--
(1) It shall be unlawful for any person to place in
any newspaper, magazine, handbill, or other
publications, any written advertisement knowing that it
has the purpose of seeking or offering illegally to
receive, buy, or distribute a Schedule\1\ I controlled
substance. As used in this section the term
``advertisement'' includes, in addition to its ordinary
meaning, such advertisements as those for a catalog of
Schedule\1\ I controlled substances and any similar
written advertisement that has the purpose of seeking
or offering illegally to receive, buy, or distribute a
Schedule\1\ I controlled substance. The term
``advertisement'' does not include material which
merely advocates the use of a similar material, which
advocates a position or practice, and does not attempt
to propose or facilitate an actual transaction in a
Schedule\1\ I controlled substance.
(2)(A) Except as authorized by this title, it shall
be unlawful for any person by means of the Internet, to
knowingly advertise the sale or distribution of, or to
offer to sell, distribute, or dispense, a controlled
substance.
(B) Examples of activities that violate subparagraph
(A) include, but are not limited to, knowingly or
intentionally causing the placement on the Internet of
an advertisement that refers to or directs prospective
buyers to Internet sellers of controlled substances who
are not registered under section 303(i).
(C) Subparagraph (A) does not apply to material that
either--
(i) merely advertises the distribution of
controlled substances by nonpractitioners to
the extent authorized by their registration
under this title; or
(ii) merely advocates the use of a controlled
substance or includes pricing information
without attempting to facilitate an actual
transaction involving a controlled substance.
* * * * * * *
Part E--Administrative and Enforcement Provisions
* * * * * * *
Sec. 881. Forfeitures
(a) Subject Property.--The following shall be subject to
forfeiture to the United States and no property right shall
exist in them:
(1) * * *
* * * * * * *
(4) [All conveyances, including aircraft, vehicles,
or vessels, which are used, or are intended for use, to
transport, or in any manner to facilitate the
transportation, sale, receipt, possession, or
concealment of property described in paragraph (1),
(2), or (9).] Any property, real or personal, tangible
or intangible, used or intended to be used to commit,
or to facilitate the commission, of a violation of this
title or title III, and any property traceable thereto.
* * * * * * *
Sec. 882. Injunctions
(a) Jurisdiction.--The district courts of the United States
and all courts exercising general jurisdiction in the
territories and possessions of the United States shall have
jurisdiction in proceedings in accordance with the Federal
Rules of Civil Procedure to enjoin violations of this
subchapter.
(b) Jury Trial.--In case of an alleged violation of an
injunction or restraining order issued under this section,
trial shall, upon demand of the accused, be by a jury in
accordance with the Federal Rules of Civil Procedure.
(c) State Cause of Action Pertaining to Online
Pharmacies.--
(1) In any case in which the State has reason to
believe that an interest of the residents of that State
has been or is being threatened or adversely affected
by the action of a person, entity, or Internet site
that violates the provisions of section 303(i), 309(e),
or 311, the State may bring a civil action on behalf of
such residents in a district court of the United States
with appropriate jurisdiction--
(A) to enjoin the conduct which violates this
section;
(B) to enforce compliance with this section;
(C) to obtain damages, restitution, or other
compensation, including civil penalties under
section 402(b); and
(D) to obtain such other legal or equitable
relief as the court may find appropriate.
(2)(A) Prior to filing a complaint under paragraph
(1), the State shall serve a copy of the complaint upon
the Attorney General and upon the United States
Attorney for the judicial district in which the
complaint is to be filed. In any case where such prior
service is not feasible, the State shall serve the
complaint on the Attorney General and the appropriate
United States Attorney on the same day that the State's
complaint is filed in Federal district court of the
United States. Such proceedings shall be independent
of, and not in lieu of, criminal prosecutions or any
other proceedings under this title or any other laws of
the United States.
(B)(i) Not later than 120 days after the later of the
date on which a State's complaint is served on the
Attorney General and the appropriate United States
Attorney, or the date on which the complaint is filed,
the United States shall have the right to intervene as
a party in any action filed by a State under paragraph
(1).
(ii) After the 120-day period described in clause (i)
has elapsed, the United States may, for good cause
shown, intervene as a party in an action filed by a
State under paragraph (1).
(iii) Notice and an opportunity to be heard with
respect to intervention shall be afforded the State
that filed the original complaint in any action in
which the United States files a complaint in
intervention under clause (i) or a motion to intervene
under clause (ii).
(iv) The United States may file a petition for appeal
of a judicial determination in any action filed by a
State under this section.
(C) Service of a State's complaint on the United
States as required in this paragraph shall be made in
accord with the requirements of Federal Rule of Civil
Procedure 4(i)(1).
(3) For purposes of bringing any civil action under
paragraph (1), nothing in this Act shall prevent an
attorney general of a State from exercising the powers
conferred on the attorney general of a State by the
laws of such State to conduct investigations or to
administer oaths or affirmations or to compel the
attendance of witnesses of or the production of
documentary or other evidence.
(4) Any civil action brought under paragraph (1) in a
district court of the United States may be brought in
the district in which the defendant is found, is an
inhabitant, or transacts business or wherever venue is
proper under section 1391 of title 28, United States
Code. Process in such action may be served in any
district in which the defendant is an inhabitant or in
which the defendant may be found.
(5) No private right of action is created under this
subsection.
* * * * * * *
Subchapter II--Import and Export
* * * * * * *
Sec. 960. Prohibited acts A
(a) Unlawful Acts.--
* * * * * * *
(b) Penalties.--
(1) * * *
* * * * * * *
(3) In the case of a violation under subsection (a)
of this section involving a controlled substance in
schedule I or II, gamma hydroxybutyric acid (including
when scheduled as an approved drug product for purposes
of section 3(a)(1)(B) of the Hillory J. Farias and
Samantha Reid Date-Rape Drug Prohibition Act of 2000),
or flunitrazepam, the person committing such violation
shall, except as provided in paragraphs (1), (2), and
(4), be sentenced to a term of imprisonment of not more
than 20 years and if death or serious bodily injury
results from the use of such substance shall be
sentenced to a term of imprisonment of not less than
twenty years and not more than life, a fine not to
exceed the greater of that authorized in accordance
with the provisions of title 18 or $1,000,000 if the
defendant is an individual or $5,000,000 if the
defendant is other than an individual, or both. If any
person commits such a violation after a prior
conviction for a felony drug offense has become final,
such person shall be sentenced to a term of
imprisonment of not more than 30 years and if death or
serious bodily injury results from the use of such
substance shall be sentenced to life imprisonment, a
fine not to exceed the greater of twice that authorized
in accordance with the provisions of title 18 or
$2,000,000 if the defendant is an individual or
$10,000,000 if the defendant is other than an
individual, or both. Notwithstanding section 3583 of
title 18, any sentence imposing a term of imprisonment
under this paragraph shall, in the absence of such a
prior conviction, impose a term of supervised release
of at least 3 years in addition to such term of
imprisonment and shall, if there was such a prior
conviction, impose a term of supervised release of at
least 6 years in addition to such term of imprisonment.
Notwithstanding the prior sentence, and notwithstanding
any other provision of law, the court shall not place
on probation or suspend the sentence of any person
sentenced under the provisions of this paragraph which
provide for a mandatory term of imprisonment if death
or serious bodily injury results[, nor shall a person
so sentenced be eligible for parole during the term of
such a sentence].
(4) In the case of a violation under subsection (a)
of this section with respect to less than 50 kilograms
of marihuana, except in the case of 100 or more
marihuana plants regardless of weight, less than 10
kilograms of hashish, or less than one kilogram of
hashish oil, [or any quantity of a controlled substance
in schedule III, IV, or V,\3\ (except a violation
involving flunitrazepam and except a violation
involving gamma hydroxybutyric acid)] the person
committing such violation shall be [imprisoned not more
than five years, or be fined not to exceed the greater
of that authorized in accordance with the provisions of
title 18 or $250,000 if the defendant is an individual
or $1,000,000 if the defendant is other than an
individual, or both. If a sentence under this paragraph
provides for imprisonment, the sentence shall,
notwithstanding section 3583 of title 18, in addition
to such term of imprisonment, include (A) a term of
supervised release of not less than two years if such
controlled substance is in schedule I, II, III, or (B)
a term of supervised release of not less than one year
if such controlled substance is in schedule IV]
sentenced in accordance with section 401(b)(1)(D) of
this title (21 U.S.C. 841(b)(1)(E)).
(5) In the case of a violation of subsection (a) of
this section involving a controlled substance in
schedule III, such person shall be sentenced in
accordance with section 401(b)(1)(E).
(6) In the case of a violation of subsection (a) of
this section involving a controlled substance in
schedule IV (except a violation involving
flunitrazepam), such person shall be sentenced in
accordance with section 401(b)(2).
(7) In the case of a violation of subsection (a) of
this section involving a controlled substance in
schedule V, such person shall be sentenced in
accordance with section 401(b)(3).