Prohibits discrimination in the sale of prescription drugs by manufacturers to pharmacists or wholesalers, requiring: (1) terms as favorable as those provided to foreign purchasers; and (2) full access to drugs permitted to be imported.
Continues the requirement that exported donated prescription drugs may only be reimported by the manufacturer.
Permits the Secretary to waive the prohibition against importing a prescription drug or device on a case-by-case basis, particularly those from Canada that are FDA-approved and for limited personal use.
Requires a study and report by the: (1) Institute of Medicine of the National Academy of Sciences on the regulatory compliance of importers of drugs; and (2) Comptroller General on how drug prices were affected.
[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 2244 Introduced in Senate (IS)]
107th CONGRESS
2d Session
S. 2244
To permit commercial importation of prescription drugs from Canada, and
for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 24, 2002
Mr. Dorgan (for himself, Mr. Jeffords, Ms. Collins, Ms. Stabenow, Ms.
Snowe, Mr. Wellstone, Mr. Levin, and Mr. Dayton) introduced the
following bill; which was read twice and referred to the Committee on
Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To permit commercial importation of prescription drugs from Canada, and
for other purposes.
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 may be cited as the ``Prescription Drug Price Parity for
Americans Act''.
SEC. 2. IMPORTATION OF PRESCRIPTION DRUGS.
(a) In General.--Chapter VIII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381 et seq.) is amended by striking section 804
and inserting the following:
``SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS.
``(a) Definitions.--In this section:
``(1) Importer.--The term `importer' means a pharmacist or
wholesaler.
``(2) Pharmacist.--The term `pharmacist' means a person
licensed by a State to practice pharmacy, including the
dispensing and selling of prescription drugs.
``(3) Prescription drug.--The term `prescription drug'
means a drug subject to section 503(b), other than--
``(A) a controlled substance (as defined in section
102 of the Controlled Substances Act (21 U.S.C. 802));
``(B) a biological product (as defined in section
351 of the Public Health Service Act (42 U.S.C. 262));
``(C) an infused drug (including a peritoneal
dialysis solution);
``(D) an intravenously injected drug; or
``(E) a drug that is inhaled during surgery.
``(4) Qualifying laboratory.--The term `qualifying
laboratory' means a laboratory in the United States that has
been approved by the Secretary for the purposes of this
section.
``(5) Wholesaler.--
``(A) In general.--The term `wholesaler' means a
person licensed as a wholesaler or distributor of
prescription drugs in the United States under section
503(e)(2)(A).
``(B) Exclusion.--The term `wholesaler' does not
include a person authorized to import drugs under
section 801(d)(1).
``(b) Regulations.--The Secretary, after consultation with the
United States Trade Representative and the Commissioner of Customs,
shall promulgate regulations permitting pharmacists and wholesalers to
import prescription drugs from Canada into the United States.
``(c) Limitation.--The regulations under subsection (b) shall--
``(1) require that safeguards be in place to ensure that
each prescription drug imported under the regulations complies
with section 505 (including with respect to being safe and
effective for the intended use of the prescription drug), with
sections 501 and 502, and with other applicable requirements of
this Act;
``(2) require that an importer of a prescription drug under
the regulations comply with subsections (d)(1) and (e); and
``(3) contain any additional provisions determined by the
Secretary to be appropriate as a safeguard to protect the
public health or as a means to facilitate the importation of
prescription drugs.
``(d) Information and Records.--
``(1) In general.--The regulations under subsection (b)
shall require an importer of a prescription drug under
subsection (b) to submit to the Secretary the following
information and documentation:
``(A) The name and quantity of the active
ingredient of the prescription drug.
``(B) A description of the dosage form of the
prescription drug.
``(C) The date on which the prescription drug is
shipped.
``(D) The quantity of the prescription drug that is
shipped.
``(E) The point of origin and destination of the
prescription drug.
``(F) The price paid by the importer for the
prescription drug.
``(G) Documentation from the foreign seller
specifying--
``(i) the original source of the
prescription drug; and
``(ii) the quantity of each lot of the
prescription drug originally received by the
seller from that source.
``(H) The lot or control number assigned to the
prescription drug by the manufacturer of the
prescription drug.
``(I) The name, address, telephone number, and
professional license number (if any) of the importer.
``(J)(i) In the case of a prescription drug that is
shipped directly from the first foreign recipient of
the prescription drug from the manufacturer:
``(I) Documentation demonstrating that the
prescription drug was received by the recipient
from the manufacturer and subsequently shipped
by the first foreign recipient to the importer.
``(II) Documentation of the quantity of
each lot of the prescription drug received by
the first foreign recipient demonstrating that
the quantity being imported into the United
States is not more than the quantity that was
received by the first foreign recipient.
``(III)(aa) In the case of an initial
imported shipment, documentation demonstrating
that each batch of the prescription drug in the
shipment was statistically sampled and tested
for authenticity and degradation.
``(bb) In the case of any subsequent
shipment, documentation demonstrating that a
statistically valid sample of the shipment was
tested for authenticity and degradation.
``(ii) In the case of a prescription drug that is
not shipped directly from the first foreign recipient
of the prescription drug from the manufacturer,
documentation demonstrating that each batch in each
shipment offered for importation into the United States
was statistically sampled and tested for authenticity
and degradation.
``(K) Certification from the importer or
manufacturer of the prescription drug that the
prescription drug--
``(i) is approved for marketing in the
United States; and
``(ii) meets all labeling requirements
under this Act.
``(L) Laboratory records, including complete data
derived from all tests necessary to ensure that the
prescription drug is in compliance with established
specifications and standards.
``(M) Documentation demonstrating that the testing
required by subparagraphs (J) and (L) was conducted at
a qualifying laboratory.
``(N) Any other information that the Secretary
determines is necessary to ensure the protection of the
public health.
``(2) Maintenance by the secretary.--The Secretary shall
maintain information and documentation submitted under
paragraph (1) for such period of time as the Secretary
determines to be necessary.
``(e) Testing.--The regulations under subsection (b) shall
require--
``(1) that testing described in subparagraphs (J) and (L)
of subsection (d)(1) be conducted by the importer or by the
manufacturer of the prescription drug at a qualified
laboratory;
``(2) if the tests are conducted by the importer--
``(A) that information needed to--
``(i) authenticate the prescription drug
being tested; and
``(ii) confirm that the labeling of the
prescription drug complies with labeling
requirements under this Act;
be supplied by the manufacturer of the prescription
drug to the pharmacist or wholesaler; and
``(B) that the information supplied under
subparagraph (A) be kept in strict confidence and used
only for purposes of testing or otherwise complying
with this Act; and
``(3) may include such additional provisions as the
Secretary determines to be appropriate to provide for the
protection of trade secrets and commercial or financial
information that is privileged or confidential.
``(f) Registration of Foreign Sellers.--Any establishment within
Canada engaged in the distribution of a prescription drug that is
imported or offered for importation into the United States shall
register with the Secretary the name and place of business of the
establishment.
``(g) Suspension of Importation.--The Secretary shall require that
importations of a specific prescription drug or importations by a
specific importer under subsection (b) be immediately suspended on
discovery of a pattern of importation of the prescription drugs or by
the importer that is counterfeit or in violation of any requirement
under this section, until an investigation is completed and the
Secretary determines that the public is adequately protected from
counterfeit and violative prescription drugs being imported under
subsection (b).
``(h) Approved Labeling.--The manufacturer of a prescription drug
shall provide an importer written authorization for the importer to
use, at no cost, the approved labeling for the prescription drug.
``(i) Prohibition of Discrimination.--
``(1) In general.--It shall be unlawful for a manufacturer
of a prescription drug to discriminate against, or cause any
other person to discriminate against, a pharmacist or
wholesaler that purchases or offers to purchase a prescription
drug from the manufacturer or from any person that distributes
a prescription drug manufactured by the drug manufacturer.
``(2) Discrimination.--For the purposes of paragraph (1), a
manufacturer of a prescription drug shall be considered to
discriminate against a pharmacist or wholesaler if the
manufacturer enters into a contract for sale of a prescription
drug, places a limit on supply, or employs any other measure,
that has the effect of--
``(A) providing pharmacists or wholesalers access
to prescription drugs on terms or conditions that are
less favorable than the terms or conditions provided to
a foreign purchaser (other than a charitable or
humanitarian organization) of the prescription drug; or
``(B) restricting the access of pharmacists or
wholesalers to a prescription drug that is permitted to
be imported into the United States under this section.
``(j) Charitable Contributions.--Notwithstanding any other
provision of this section, section 801(d)(1) continues to apply to a
prescription drug that is donated or otherwise supplied at no charge by
the manufacturer of the drug to a charitable or humanitarian
organization (including the United Nations and affiliates) or to a
government of a foreign country.
``(k) Waiver Authority for Importation by Individuals.--
``(1) Declarations.--Congress declares that in the
enforcement against individuals of the prohibition of
importation of prescription drugs and devices, the Secretary
should--
``(A) focus enforcement on cases in which the
importation by an individual poses a significant threat
to public health; and
``(B) exercise discretion to permit individuals to
make such importations in circumstances in which--
``(i) the importation is clearly for
personal use; and
``(ii) the prescription drug or device
imported does not appear to present an
unreasonable risk to the individual.
``(2) Waiver authority.--
``(A) In general.--The Secretary may grant to
individuals, by regulation or on a case-by-case basis,
a waiver of the prohibition of importation of a
prescription drug or device or class of prescription
drugs or devices, under such conditions as the
Secretary determines to be appropriate.
``(B) Guidance on case-by-case waivers.--The
Secretary shall publish, and update as necessary,
guidance that accurately describes circumstances in
which the Secretary will consistently grant waivers on
a case-by-case basis under subparagraph (A), so that
individuals may know with the greatest practicable
degree of certainty whether a particular importation
for personal use will be permitted.
``(3) Drugs imported from canada.--In particular, the
Secretary shall by regulation grant individuals a waiver to
permit individuals to import into the United States a
prescription drug that--
``(A) is imported from a licensed pharmacy for
personal use by an individual, not for resale, in
quantities that do not exceed a 90-day supply;
``(B) is accompanied by a copy of a valid
prescription;
``(C) is imported from Canada, from a seller
registered with the Secretary;
``(D) is a prescription drug approved by the
Secretary under chapter V;
``(E) is in the form of a final finished dosage
that was manufactured in an establishment registered
under section 510; and
``(F) is imported under such other conditions as
the Secretary determines to be necessary to ensure
public safety.
``(l) Studies; Reports.--
``(1) By the institute of medicine of the national academy
of sciences.--
``(A) Study.--
``(i) In general.--The Secretary shall
request that the Institute of Medicine of the
National Academy of Sciences conduct a study
of--
``(I) importations of prescription
drugs made under the regulations under
subsection (b); and
``(II) information and
documentation submitted under
subsection (d).
``(ii) Requirements.--In conducting the
study, the Institute of Medicine shall--
``(I) evaluate the compliance of
importers with the regulations under
subsection (b);
``(II) compare the number of
shipments under the regulations under
subsection (b) during the study period
that are determined to be counterfeit,
misbranded, or adulterated, and compare
that number with the number of
shipments made during the study period
within the United States that are
determined to be counterfeit,
misbranded, or adulterated; and
``(III) consult with the Secretary,
the United States Trade Representative,
and the Commissioner of Patents and
Trademarks to evaluate the effect of
importations under the regulations
under subsection (b) on trade and
patent rights under Federal law.
``(B) Report.--Not later than 2 years after the
effective date of the regulations under subsection (b),
the Institute of Medicine shall submit to Congress a
report describing the findings of the study under
subparagraph (A).
``(2) By the comptroller general.--
``(A) Study.--The Comptroller General of the United
States shall conduct a study to determine the effect of
this section on the price of prescription drugs sold to
consumers at retail.
``(B) Report.--Not later than 18 months after the
effective date of the regulations under subsection (b),
the Comptroller General of the United States shall
submit to Congress a report describing the findings of
the study under subparagraph (A).
``(m) Construction.--Nothing in this section limits the authority
of the Secretary relating to the importation of prescription drugs,
other than with respect to section 801(d)(1) as provided in this
section.
``(n) Authorization of Appropriations.--There are authorized to be
appropriated such sums as are necessary to carry out this section.''.
(b) Conforming Amendments.--The Federal Food, Drug, and Cosmetic
Act is amended--
(1) in section 301(aa) (21 U.S.C. 331(aa)), by striking
``covered product in violation of section 804'' and inserting
``prescription drug in violation of section 804'';
(2) in section 303(a)(6) (21 U.S.C. 333(a)(6), by striking
``covered product pursuant to section 804(a)'' and inserting
``prescription drug under section 804(b)''.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S3316)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S3316-3318)
Sponsor introductory remarks on measure. (CR S3794, S3795)
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