[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 215 Introduced in Senate (IS)]
107th CONGRESS
1st Session
S. 215
To amend the Federal Food, Drug, and Cosmetic Act to permit importation
in personal baggage and by mail of certain covered products for
personal use from certain foreign countries and to correct impediments
in implementation of the Medicine Equity and Drug Safety Act of 2000.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
January 30, 2001
Ms. Stabenow introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to permit importation
in personal baggage and by mail of certain covered products for
personal use from certain foreign countries and to correct impediments
in implementation of the Medicine Equity and Drug Safety Act of 2000.
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 ``Medication Equity and Drug Savings
Act''.
SEC. 2. IMPORTATION OF COVERED PRODUCTS FOR PERSONAL USE.
(a) In General.--Chapter VIII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381 et seq.) is amended by adding at the end
the following:
``SEC. 805. IMPORTATION OF COVERED PRODUCTS FOR PERSONAL USE.
``(a) Definitions.--In this section:
``(1) Covered product.--The term `covered product' means a
prescription drug described in section 503(b)(1).
``(2) Foreign country.--The term `foreign country' means--
``(A) Australia, Canada, Israel, Japan, New
Zealand, Switzerland, and South Africa; and
``(B) any other country, union, or economic area
that the Secretary designates for the purposes of this
section, subject to such limitations as the Secretary
determines to be appropriate to protect the public
health.
``(3) Market value.--The term `market value' means--
``(A) the price paid for a covered product in
foreign country; or
``(B) in the case of a gift, the price at which the
covered product is being sold in the foreign country
from which the covered product is imported.
``(b) Importation in Person.--
``(1) Regulations.--Notwithstanding subsections (d) and (t)
of section 301 and section 801(a), the Secretary shall
promulgate regulations permitting individuals to import into
the United States from a foreign country, in personal baggage,
a covered product that meets--
``(A) the conditions specified in paragraph (2);
and
``(B) such additional criteria as the Secretary
specifies to ensure the safety of patients in the
United States.
``(2) Conditions.--A covered product may be imported under
the regulations if--
``(A) the intended use of the covered product is
appropriately identified;
``(B) the covered product is not considered to
represent a significant health risk (as determined by
the Secretary without any consideration given to the
cost or availability of such a product in the United
States); and
``(C) the individual seeking to import the covered
product--
``(i) states in writing that the covered
product is for the personal use of the
individual;
``(ii) seeks to import a quantity of the
covered product appropriate for personal use,
such as a 90-day supply;
``(iii) provides the name and address of a
health professional licensed to prescribe drugs
in the United States that is responsible for
treatment with the covered product or provides
evidence that the covered product is for the
continuation of a treatment begun in a foreign
country;
``(iv) provides a detailed description of
the covered product being imported, including
the name, quantity, and market value of the
covered product;
``(v) provides the time when and the place
where the covered product is purchased;
``(vi) provides the port of entry through
which the covered product is imported;
``(vii) provides the name, address, and
telephone number of the individual who is
importing the covered product; and
``(viii) provides any other information
that the Secretary determines to be necessary,
including such information as the Secretary
determines to be appropriate to identify the
facility in which the covered product was
manufactured.
``(3) Importation by an individual other than the
patient.--The regulations shall permit an individual who seeks
to import a covered product under this subsection to designate
another individual to effectuate the importation if the
individual submits to the Secretary a certification by a health
professional licensed to prescribe drugs in the United States
that travelling to a foreign country to effectuate the
importation would pose a significant risk to the health of the
individual.
``(4) Consultation.--In promulgating regulations under
paragraph (1), the Secretary shall consult with the United
States Trade Representative and the Commissioner of Customs.
``(c) Importation by Mail.--
``(1) Regulations.--Notwithstanding subsections (d) and (t)
of section 301 and section 801(a), the Secretary shall
promulgate regulations permitting individuals to import into
the United States by mail a covered product that meets such
criteria as the Secretary specifies to ensure the safety of
patients in the United States.
``(2) Criteria.--In promulgating regulations under
paragraph (1), the Secretary shall impose the conditions
specified in subsection (b)(2) to the maximum extent
practicable.
``(3) Consultation.--In promulgating regulations under
paragraph (1), the Secretary shall consult with the United
States Trade Representative and the Commissioner of Customs.
``(d) Records.--Any information documenting the importation of a
covered product under subsections (b) and (c) shall be gathered and
maintained by the Secretary for such period as the Secretary determines
to be appropriate.
``(e) Study and Report.--
``(1) Study.--The Secretary shall conduct a study on the
imports permitted under this section, taking into consideration
the information received under subsections (b) and (c).
``(2) Evaluations.--In conducting the study, the Secretary
shall evaluate--
``(A) the safety and purity of the covered products
imported; and
``(B) patent, trade, and other issues that may have
an effect on the safety or availability of the covered
products.
``(3) Report.--Not later than 5 years after the date of
enactment of this section, the Secretary shall submit to
Congress a report describing the results of the study.
``(f) No Effect on Other Authority.--Nothing in this section limits
the statutory, regulatory, or enforcement authority of the Secretary
relating to importation of covered products, other than the importation
described in subsections (b) and (c).
``(g) Limitation.--Information collected under this section shall
be subject to section 522a of title 5, United States Code.''.
(b) Conforming Amendment.--Section 801(d)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(d)(1)) is amended by striking
``section 804'' and inserting ``sections 804 and 805''.
SEC. 3. CORRECTION OF IMPEDIMENTS IN IMPLEMENTATION OF MEDICINE EQUITY
AND DRUG SAFETY ACT OF 2000.
(a) Access to Labeling to Permit Importation.--Section 804 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) is amended--
(1) in subsection (b)--
(A) in paragraph (2), by striking ``and'' at the
end;
(B) in paragraph (3), by striking the period at the
end and inserting ``; and''; and
(C) by adding at the end the following paragraph:
``(4) specify a fair and reasonable fee that a manufacturer
may charge an importer for printing and shipping labels for a
covered product for use by the importer.'';
(2) in subsection (e)(2), by inserting after ``used only
for purposes of testing'' the following: ``or the labeling of
covered products''; and
(3) in subsection (h)--
(A) by striking ``No manufacturer'' and inserting
the following:
``(1) In general.--No manufacturer''; and
(B) by adding at the end the following:
``(2) No conditions for labeling.--No manufacturer of a
covered product may impose any condition for the privilege of
an importer in using labeling for a covered product, except a
requirement that the importer pay a fee for such use
established by regulation under subsection (b)(4).''.
(b) Prohibition of Pricing Conditions.--Paragraph (1) of section
804(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(h))
(as designated by subsection (a)(3)(A)) is amended by inserting before
the period at the end the following: ``that--
``(A) imposes a condition regarding the price at
which an importer may resell a covered product; or
``(B) discriminates against a person on the basis
of--
``(i) importation by the person of a
covered product imported under subsection (a);
or
``(ii) sale or distribution by the person
of such covered products''.
(c) Conditions for Taking Effect.--Section 804 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 384) is amended by striking
subsection (l) and inserting the following:
``(l) Conditions for Taking Effect.--
``(1) In general.--Except as provided in paragraph (2),
this section shall become effective only if the Secretary
certifies to Congress that there is no reasonable likelihood
that the implementation of this section would pose any
appreciable additional risk to the public health or safety.
``(2) Regulations.--Notwithstanding the failure of the
Secretary to make a certification under paragraph (1), the
Secretary, not later than 30 days after the date of enactment
of this paragraph, shall commence a rulemaking for the purpose
of formulating regulations to enable the Secretary to implement
this section immediately upon making such a certification.''.
(d) Repeal of Sunset Provision.--Section 804 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 384) is amended by striking
subsection (m).
(e) Authorization of Appropriations.--Section 804 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 384) (as amended by subsection
(d)) is amended by adding at the end the following:
``(m) Authorization of Appropriations.--There are authorized to be
appropriated for fiscal year 2002 and each subsequent fiscal year such
sums as are necessary to carry out this section.''.
<all>