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106th CONGRESS
2d Session
H. R. 5476
To amend the Federal Food, Drug, and Cosmetic Act to enhance consumer
protection in the purchase of prescription drugs from interstate
Internet sellers.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 17, 2000
Mr. Bliley (for himself, Mr. Klink, and Mr. Upton) introduced the
following bill; which was referred to the Committee on Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to enhance consumer
protection in the purchase of prescription drugs from interstate
Internet sellers.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act be cited as the ``Internet Prescription Drug Consumer
Protection Act of 2000''.
SEC. 2. FINDINGS AND PURPOSE.
(a) Findings.--Congress makes the following findings:
(1) Legitimate Internet sellers of prescription drugs can
offer substantial benefits to consumers. These potential
benefits include convenience, privacy, valuable information,
competitive prices, and personalized services.
(2) Unlawful Internet sellers of prescription drugs may
dispense inappropriate, contaminated, counterfeit, or subpotent
prescription drugs that could put at risk the health and safety
of consumers.
(3) Unlawful Internet sellers have exposed consumers to
significant health risks by knowingly filling invalid
prescriptions, such as prescriptions based solely on an online
questionnaire, or by dispensing prescription drugs without any
prescription.
(4) The ease with which web sites can be created and
removed and the lack of readily available information to
identify Internet sellers creates significant barriers to
effective law enforcement efforts against unlawful Internet
sellers.
(5) Consumers may have difficulty distinguishing legitimate
from unlawful Internet sellers, as well as foreign from
domestic Internet sellers, of prescription drugs.
(6) States need additional enforcement tools to take
effective action against unlawful domestic Internet sellers and
the Federal agencies need additional enforcement tools to take
effective action against unlawful foreign Internet sellers.
(b) Purpose.--The purpose of this Act is to provide Federal and
State law enforcement with adequate tools to take effective action
against interstate Internet sellers of prescription drugs who illegally
sell such drugs to consumers in the United States and to protect such
consumers against potential harms that may result from purchasing such
drugs from such sellers.
SEC. 3. AMENDMENT TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503A
the following:
``SEC. 503B. INTERNET PRESCRIPTION DRUG SALES.
``(a) Definitions.--For purposes of this section:
``(1) Consumer.--The term `consumer' means a person (other
than an entity licensed or otherwise authorized under Federal
or State law as a pharmacy or to dispense or distribute
prescription drugs) that purchases or seeks to purchase
prescription drugs through the Internet.
``(2) Home page.--The term `home page' means the entry
point or main web page for an Internet site.
``(3) Internet.--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 protocols to such protocol, to
communicate information of all kinds by wire or radio,
including electronic mail.
``(4) Interstate internet seller.--
``(A) In general.--The term `interstate Internet
seller' means a person whether in the United States or
abroad, that engages in, offers to engage in, or causes
the delivery or sale of a prescription drug through the
Internet and has such drug delivered directly to the
consumer via the Postal Service, or any private or
commercial interstate carrier to a consumer in the
United States who is residing in a State other than the
State in which the seller's place of business is
located. This definition excludes a person who only
delivers a prescription drug to a consumer, such as an
interstate carrier service.
``(B) Exemption.--With respect to the consumer
involved, the term `interstate Internet seller' does
not include a person described in subparagraph (A)
whose place of business is located within 75 miles of
the consumer.
``(5) Link.--The term `link' means either a textual or
graphical marker on a web page that, when clicked on, takes the
consumer to another part of the Internet, such as to another
web page or a different area on the same web page, or from an
electronic message to a web page.
``(6) Pharmacy.--The term `pharmacy' means any place
licensed or otherwise authorized as a pharmacy under State law.
``(7) Prescriber.--The term `prescriber' means an
individual, licensed or otherwise authorized under applicable
Federal and State law to issue prescriptions for prescription
drugs.
``(8) Prescription drug.--The term `prescription drug'
means a drug under section 503(b)(1).
``(9) Valid prescription.--The term `valid prescription'
means a prescription that meets the requirements of section
503(b)(1) and other applicable Federal and State law.
``(10) Web site; site.--The terms `web site' and `site'
mean a specific location on the Internet that is determined by
Internet protocol numbers or by a domain name.
``(b) Requirements for Interstate Internet Sellers.--
``(1) In general.--Each interstate Internet seller shall
comply with the requirements of this subsection with respect to
the sale of, or the offer to sell, prescription drugs through
the Internet and shall at all times display on its web site
information in accordance with paragraph (2).
``(2) Web site disclosure information.--An interstate
Internet seller shall post in a visible and clear manner (as
determined by regulation) on the home page of its web site, or
on a page directly linked to such home page--
``(A) the street address of the interstate Internet
seller's place of business, and the telephone number of
such place of business;
``(B) each State in which the interstate Internet
seller is licensed or otherwise authorized as a
pharmacy, or if the interstate Internet seller is not
licensed or otherwise authorized by a State as a
pharmacy, each State in which the interstate Internet
seller is licensed or otherwise authorized to dispense
prescription drugs, and the type of State license or
authorization;
``(C) in the case of an interstate Internet seller
that makes referrals to or solicits on behalf of a
prescriber, the name of each prescriber, the street
address of each such prescriber's place of business,
the telephone number of such place of business, each
State in which each such prescriber is licensed or
otherwise authorized to prescribe prescription drugs,
and the type of such license or authorization; and
``(D) a statement that the interstate Internet
seller will dispense prescription drugs only upon a
valid prescription.
``(3) Date of posting.--Information required to be posted
under paragraph (2) shall be posted by an interstate Internet
seller--
``(A) not later than 90 days after the effective
date of this section if the web site of such seller is
in operation as of such date; or
``(B) on the date of the first day of operation of
such seller's web site if such site goes into operation
after such date.
``(4) Qualifying statements.--An interstate Internet seller
shall not indicate in any manner that posting disclosure
information on its web site signifies that the Federal
Government has made any determination on the legitimacy of the
interstate Internet seller or its business.
``(5) Disclosure to state licensing boards.--An interstate
Internet seller licensed or otherwise authorized to dispense
prescription drugs in accordance with applicable State law
shall notify each State entity that granted such licensure or
authorization that it is an interstate Internet seller, the
name of its business, the Internet address of its business, the
street address of its place of business, and the telephone
number of such place of business.
``(6) Regulations.--The Secretary is authorized to
promulgate such regulations as are necessary to carry out the
provisions of this subsection. In issuing such regulations, the
Secretary--
``(A) shall take into consideration disclosure
formats used by existing interstate Internet seller
certification programs; and
``(B) shall in defining the term `place of
business' include provisions providing that such place
is a single location at which employees of the business
perform job functions, and not a post office box or
similar locale.''.
(b) State Enforcement of Federal Law Regarding Internet Sellers of
Prescription Drugs.--Chapter III of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331 et seq.) is amended by adding at the end
the following:
``state proceedings regarding internet sales of prescription drugs
``Sec. 310A. (a) In General.--A State, through its attorney
general, may bring in its own name, and in an appropriate district
court of the United States, proceedings against an interstate Internet
seller of a prescription drug for the civil enforcement, or to restrain
violations of section 503B(b), or paragraph (1) or (2) of section
503(b), on behalf of consumers who reside in that State and have been
or are being adversely affected by such violations. Through such
proceedings, the State may with respect to such violations--
``(1) obtain a permanent nationwide injunction;
``(2) enforce compliance; or
``(3) obtain such other relief as the court may find
appropriate.
``(b) Notice to Secretary and Appropriate Federal Agencies.--A
State--
``(1) shall serve prior written notice of any civil action
under subsection (a) upon the Secretary and the appropriate
Federal agencies and provide to the Secretary and such agencies
a copy of its complaint, except in any case where such prior
notice is not feasible, in which case the State shall serve
such notice immediately upon instituting such action; and
``(2) may proceed with the civil action unless another
State attorney general or a Federal agency has filed a
complaint against the same party for the same violations under
this section prior to receiving notice and the civil action
brought by the State attorney general or such agency is still
ongoing or there has been a final judgment.
``(c) Rights of President.--The President shall have the right to
intervene in any action brought under subsection (a), and upon so
intervening, to be heard in all matters arising therein and to file
notices of appeal.
``(d) Applicability of Subpoenas.--Subpoenas for witnesses who are
required to attend a court of the United States, in any district, may
run into any other district in any proceeding under this section.
``(e) Construction.--For purposes of bringing any civil action
under subsection (a), nothing in this section shall prevent a State
attorney general from exercising the powers conferred on the attorney
general by the laws of such State to conduct investigations or to
administer oaths or affirmations or to compel the attendance of
witnesses or the production of documentary or other evidence or to
bring an action under the laws of such State to obtain remedies under
that State's laws.
``(f) Definitions.--For purposes of this section, the terms
`interstate Internet seller', `Internet', and `prescription drug' have
the meanings given such terms in section 503B.''.
(c) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
``(aa) The failure to post information required under section
503B(b)(2) or for knowingly making a materially false statement when
posting such information as required under such section or violating
section 503B(b)(4).''.
SEC. 4. PUBLIC EDUCATION.
The Secretary of Health and Human Services shall engage in
activities to educate the public about the dangers of purchasing
prescription drugs from unlawful Internet sources. The Secretary should
educate the public about effective public and private sector consumer
protection efforts, as appropriate, with input from the public and
private sectors, as appropriate.
SEC. 5. STUDY REGARDING COORDINATION OF REGULATORY ACTIVITIES.
Not later than 180 days after the date of enactment of this Act,
the Secretary of Health and Human Services, after consultation with the
Attorney General, shall submit to Congress a report providing
recommendations for coordinating the activities of Federal agencies
regarding interstate Internet sellers that operate from foreign
countries and for coordinating the activities of the Federal Government
with the activities of governments of foreign countries regarding such
interstate Internet sellers.
SEC. 6. CIVIL ACTIONS REGARDING PROPERTY.
Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
333) is amended by adding at the end the following subsection:
``(i)(1) If a person is alienating or disposing of property, or
intends to alienate or dispose of property which is obtained as a
result of or is traceable to a violation by an interstate Internet
seller of paragraph (1) or (2) of section 503(b), the President may
commence a civil action in any Federal court--
``(A) to enjoin such alienation or disposition of property;
or
``(B) for a restraining order to--
``(i) prohibit any person from withdrawing,
transferring, removing, dissipating, or disposing of
any such property or property of equivalent value; and
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