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SEC. 740. AMENDMENT TO FEDERAL, FOOD, DRUG AND COSMETIC ACT.
(a) SHORT TITLE.- This section may be cited as the
"MEDICINE EQUITY and DRUG SAFETY ACT of 2000".
(b) FINDINGS.- Congress makes the following findings:
(1) The cost of prescription drugs for Americans continues to rise
at an alarming rate.
(2) Millions of Americans, including Medicare beneficiaries on
fixed incomes, face a daily choice between purchasing
life-sustaining prescription drugs, or paying for other necessities,
such as food and housing.
(3) Many life-saving prescription drugs are available in countries
other than the United States at substantially lower prices, even
though such drugs were developed and are approved for use by
patients in the United States.
(4) Many Americans travel to other countries to purchase
prescriptions drugs because the medicines that they need are
unaffordable in the United States.
(5) Americans should be able to purchase medicines at prices
that are comparable to prices for such medicines in other
countries, but efforts to enable such purchases should not
endanger the gold standard for safety and effectiveness that has
been established and maintained in the United States.
(c) AMENDMENT.- Chapter VIII of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381 et seq.) is amended.-
(1) in section 801(d)(1), by inserting "and section 804" after
"paragraph (2)"; and
(2) by adding at the end the following:
"SEC. 804. IMPORTATION OF COVERED PRODUCTS.
"(a) REGULATIONS.-
"(1) IN GENERAL.- Notwithstanding sections 301(d), 301(t),
and 801(a), the Secretary, after consultation with the United
States Trade Representative and the Commissioner of Customs,
shall promulgate regulations permitting importation into the United
States of covered products.
"(2) LIMITATIONS.- Regulations promulgated under paragraph
No. (1) shall-
"(A) require that safeguards are in place that provide a
reasonable assurance to the Secretary that each covered product
that is imported is safe and effective for its intended use;
"(B) require that the pharmacist or wholesaler importing a
covered product complies with the provisions of subsection (b);
and
"(C) contain such additional safeguards as the Secretary may
specify in order to ensure the protection of the public health of
patients in the United States...
Excerpt:
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND
DRUG ADMINISTRATION AND RELATED AGENCIES
APPROPRIATIONS ACT 2001.
H.R. 4461 EAS (Engrossed Senate Amendment)
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SAN DIEGO UNION-TRIBUNE Sept. 21, 2000 (quoted)
"Bipartisan Group Plugs Reimporting Cheaper Drugs"
With a prescription drug plan for seniors all but abandoned for
the year, Democrats in the Senate are vowing to make the
legislation [H.R. 4461] a test of the leadership's commitment to
more affordable drugs...
Senate Minority Leader Tom Daschle, D-S.D., said yesterday
that the lack of progress on the agriculture bill, which is stalled in
a conference committee, makes him suspect that Republican
leaders are looking for a way to kill the reimportation provision...
"The only safety concern the pharmaceutical industry has is they
want to be safe to make huge profits on the misery and illness of
consumers," said Sen. Paul Wellstone, D-Minn., a co-sponsor of
the measure.
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