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108th CONGRESS
1st Session
H. R. 2427
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 25 (legislative day, July 21), 2003
Received; read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
AN ACT
To authorize the Secretary of Health and Human Services to promulgate
regulations for the reimportation of prescription drugs, 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 ``Pharmaceutical Market Access Act of
2003''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Americans unjustly pay up to 1000 percent more to fill
their prescriptions than consumers in other countries.
(2) The United States is the world's largest market for
pharmaceuticals yet consumers still pay the world's highest
prices.
(3) An unaffordable drug is neither safe nor effective.
Allowing and structuring the importation of prescription drugs
ensures access to affordable drugs, thus providing a level of
safety to American consumers they do not currently enjoy.
(4) According to the Congressional Budget Office, American
seniors alone will spend $1.8 trillion dollars on
pharmaceuticals over the next ten years.
(5) Allowing open pharmaceutical markets could save
American consumers at least $635 billion of their own money
each year.
SEC. 3. PURPOSES.
The purposes of this Act are as follows:
(1) To give all Americans immediate relief from the
outrageously high cost of pharmaceuticals.
(2) To reverse the perverse economics of the American
pharmaceutical markets.
(3) To allow the importation of drugs only if the drugs and
the facilities where they are manufactured are approved by the
Food and Drug Administration, and to exclude pharmaceutical
narcotics.
(4) To require that imported prescription drugs be packaged
and shipped using counterfeit-resistant technologies approved
by the Bureau of Engraving and Printing (technologies similar
to those used to secure United States currency).
SEC. 4. IMPORTATION OF PRESCRIPTION DRUGS.
Section 804 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
384) is amended--
(1) in subsection (a)--
(A) by striking ``The Secretary'' and inserting
``Not later than 180 days after the date of the
enactment of the Pharmaceutical Market Access Act of
2003, the Secretary''; and
(B) by striking ``pharmacists and wholesalers'' and
inserting ``pharmacists, wholesalers, and qualifying
individuals'';
(2) in subsection (b)--
(A) by amending paragraph (1) to read as follows:
``(1) require that each covered product imported pursuant
to such subsection complies with sections 501, 502, and 505,
and other applicable requirements of this Act; and'';
(B) in paragraph (2), by striking ``, including
subsection (d); and'' and inserting a period; and
(C) by striking paragraph (3);
(3) in subsection (c), by inserting ``by pharmacists and
wholesalers (but not qualifying individuals)'' after
``importation of covered products'';
(4) in subsection (d)--
(A) by striking paragraphs (3) and (10);
(B) in paragraph (5), by striking ``, including the
professional license number of the importer, if any'';
(C) in paragraph (6)--
(i) in subparagraph (C), by inserting ``(if
required under subsection (e))'' before the
period;
(ii) in subparagraph (D), by inserting
``(if required under subsection (e))'' before
the period; and
(iii) in subparagraph (E), by striking
``labeling'';
(D) in paragraph (7)--
(i) in subparagraph (A), by inserting ``(if
required under subsection (e))'' before the
period; and
(ii) by amending subparagraph (B) to read
as follows:
``(B) Certification from the importer or
manufacturer of such product that the product meets all
requirements of this Act.''; and
(E) by redesignating paragraphs (4) through (9) as
paragraphs (3) through (8), respectively;
(5) by amending subsection (e) to read as follows:
``(e) Testing.--
``(1) In general.--Subject to paragraph (2), regulations
under subsection (a) shall require that testing referred to in
paragraphs (5) through (7) of subsection (d) be conducted by
the importer of the covered product, unless the covered product
is a prescription drug subject to the requirements of section
505B for counterfeit-resistant technologies.
``(2) Exception.--The testing requirements of paragraphs
(5) through (7) of subsection (d) shall not apply to an
importer unless the importer is a wholesaler.'';
(6) in subsection (f), by striking ``or designated by the
Secretary, subject to such limitations as the Secretary
determines to be appropriate to protect the public health'';
(7) in subsection (g)--
(A) by striking ``counterfeit or''; and
(B) by striking ``and the Secretary determines that
the public is adequately protected from counterfeit and
violative covered products being imported pursuant to
subsection (a)'';
(8) in subsection (i)(1)--
(A) by amending subparagraph (A) to read as
follows:
``(A) In general.--The Secretary shall conduct, or
contract with an entity to conduct, a study on the
imports permitted pursuant to subsection (a), including
consideration of the information received under
subsection (d). In conducting such study, the Secretary
or entity shall evaluate the compliance of importers
with regulations under subsection (a), and the
incidence of shipments pursuant to such subsection, if
any, that have been determined to be misbranded or
adulterated, and determine how such compliance
contrasts with the incidence of shipments of
prescription drugs transported within the United States
that have been determined to be misbranded or
adulterated.''; and
(B) in subparagraph (B), by striking ``Not later
than 2 years after the effective date of final
regulations under subsection (a),'' and inserting ``Not
later than 18 months after the date of the enactment of
the Pharmaceutical Market Access Act of 2003,'';
(9) in subsection (k)(2)--
(A) by redesignating subparagraphs (D) and (E) as
subparagraphs (E) and (F), respectively; and
(B) by inserting after subparagraph (C) the
following:
``(D) The term `qualifying individual' means an
individual who is not a pharmacist or a wholesaler. '';
and
(10) by striking subsections (l) and (m).
SEC. 5. USE OF COUNTERFEIT-RESISTANT TECHNOLOGIES TO PREVENT
COUNTERFEITING.
(a) Misbranding.--Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352; deeming drugs and devices to be
misbranded) is amended by adding at the end the following:
``(w) If it is a drug subject to section 503(b), unless the
packaging of such drug complies with the requirements of section 505B
for counterfeit-resistant technologies.''.
(b) Requirements.--Title V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505A
the following:
``SEC. 505B. COUNTERFEIT-RESISTANT TECHNOLOGIES.
``(a) Incorporation of Counterfeit-Resistant Technologies Into
Prescription Drug Packaging.--The Secretary shall require that the
packaging of any drug subject to section 503(b) incorporate--
``(1) overt optically variable counterfeit-resistant
technologies that are described in subsection (b) and comply
with the standards of subsection (c); or
``(2) technologies that have an equivalent function of
security, as determined by the Secretary.
``(b) Eligible Technologies.--Technologies described in this
subsection--
``(1) shall be visible to the naked eye, providing for
visual identification of product authenticity without the need
for readers, microscopes, lighting devices, or scanners;
``(2) shall be similar to that used by the Bureau of
Engraving and Printing to secure United States currency;
``(3) shall be manufactured and distributed in a highly
secure, tightly controlled environment; and
``(4) should incorporate additional layers of non-visible
covert security features up to and including forensic
capability.
``(c) Standards for Packaging.--
``(1) Multiple elements.--For the purpose of making it more
difficult to counterfeit the packaging of drugs subject to
section 503(b), manufacturers of the drugs shall incorporate
the technologies described in subsection (b) into multiple
elements of the physical packaging of the drugs, including
blister packs, shrink wrap, package labels, package seals,
bottles, and boxes.
``(2) Labeling of shipping container.--Shipments of drugs
described in subsection (a) shall include a label on the
shipping container that incorporates the technologies described
in subsection (b), so that officials inspecting the packages
will be able to determine the authenticity of the shipment.
Chain of custody procedures shall apply to such labels and
shall include procedures applicable to contractual agreements
for the use and distribution of the labels, methods to audit
the use of the labels, and database access for the relevant
governmental agencies for audit or verification of the use and
distribution of the labels.''.
Passed the House of Representatives July 25 (legislative
day, July 24), 2003.
Attest:
JEFF TRANDAHL,
Clerk.
Pages: 1 Other Popular 108th Congressional Bills Documents:
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