108th CONGRESS
1st Session
S. 1974
To make improvements to the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003.
IN THE SENATE OF THE UNITED STATES
November 25, 2003
Mr. DASCHLE introduced the following bill; which was read twice and referred
to the Committee on Finance
A BILL
To make improvements to the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003.
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 `Medicare Preservation and Drug Price Fairness
Act'.
SEC. 2. AUTHORITY TO NEGOTIATE PRICES.
Subsection (i) of section 1860D-11, as added by section 101 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003, is repealed.
SEC. 3. REPEAL OF COMPARATIVE COST ADJUSTMENT (CCA) PROGRAM.
Subtitle E of title II of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, and the amendments made by such subtitle, are repealed.
SEC. 4. PHARMACEUTICAL MARKET ACCESS.
(a) IMPORTATION OF PRESCRIPTION DRUGS- Section 804 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 384) is amended--
(A) by striking `The Secretary' and inserting `Not later than 180 days
after the date of the enactment of the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003, the Secretary'; and
(B) by striking `pharmacists and wholesalers' and inserting `pharmacists,
wholesalers, and qualifying individuals';
(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';
(A) by striking paragraphs (3) and (10);
(B) in paragraph (5), by striking `, including the professional license
number of the importer, if any';
(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';
(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:
`(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';
(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 Medicare
Prescription Drug, Improvement, and Modernization 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).
(b) USE OF COUNTERFEIT-RESISTANT TECHNOLOGIES TO PREVENT COUNTERFEITING-
(1) 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.'.
(2) 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.'.
(c) REPEAL- Subtitle C of title XI of the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003, and the amendments made by such subtitle, are
repealed.
SEC. 5. ASSURING ACCESS TO COVERAGE.
Paragraph (3) of section 1860D-3(a), as added by section 101 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003, is amended
to read as follows:
`(3) QUALIFYING PLAN DEFINED- For purposes of this section, the term `qualifying
plan' means a prescription drug plan offered by a PDP sponsor.'.
SEC. 6. REPEAL OF MA REGIONAL PLAN STABILIZATION FUND.
(a) IN GENERAL- Section 1858 of the Social Security Act, as added by section
221(c) of the Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, is amended--
(1) by striking subsection (e);
(2) by redesignating subsections (f), (g), and (h) as subsections (e), (f),
and (g), respectively; and
(3) in subsection (e), as so redesignated, by striking `subject to subsection
(e),'.
(b) CONFORMING AMENDMENT- Section 1851(i)(2) of the Social Security Act (42
U.S.C. 1395w-21(i)(2)), as amended by section 221(d)(5) of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003, is amended by striking `1858(h)'
and inserting `1858(g)'.
SEC. 7. REPEAL OF HEALTH SAVINGS ACCOUNTS.
Section 1201 of the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003, and the amendments made by such section, are repealed.
SEC. 8. EFFECTIVE DATE.
(a) IN GENERAL- The amendments made by this Act shall take effect as if included
in the enactment of the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003.
(b) APPLICATION OF LAWS- If any amendment to any provision of any Act is repealed
by this Act, such provision shall be applied and administered as if the amendment
had never been enacted.
END
