S.Amdt. 820

SA 820. Mr. BINGAMAN submitted an amendment intended to be proposed
to amendment SA 769 proposed by Mr. Vitter to the amendment SA 738
proposed by Mr. Inouye to the bill H.R. 2112, making appropriations for
Agriculture, Rural Development, Food and Drug Administration, and
Related Agencies programs for the fiscal year ending September 30,
2012, and for other purposes; which was ordered to lie on the table; as
follows:

On page 1 of the amendment, strike line 8 though line 10
and insert the following: ``381(g))) from importing a
prescription drug from Canada, or from a permitted country
designated by the Secretary of Health and Human Services,
that complies with the Federal Food, Drug, and Cosmetic Act:
Provided, That the Secretary shall designate a permitted
country as a country from which an individual may import a
prescription drug in accordance with this section if the
Secretary determines that (1) the country has statutory or
regulatory standards that are equivalent to the standards in
the United States and Canada with respect to the training of
pharmacists, the practice of pharmacy, and the protection of
the privacy of personal medical information, and (2) the
importation of drugs to individuals in the United States from
the country will not adversely affect public health:
Provided further, That the term `permitted country' means--
``(1) Australia;
``(2) a member country of the European Union, but does not
include a member country with respect to which--
``(A) the country's Annex to the Treaty of Accession to the
European Union 2003 includes a transitional measure for the
regulation of human pharmaceutical products that has not
expired; or
``(B) the Secretary determines that the requirements
described in subparagraphs (A) and (B) of paragraph (6) will
not be met by the date on which such transitional measure for
the regulation of human pharmaceutical products expires;
``(3) Japan;
``(4) New Zealand;
``(5) Switzerland; and
``(6) a country in which the Secretary determines the
following requirements are met:
``(A) The country has statutory or regulatory
requirements--
``(i) that require the review of drugs for safety and
effectiveness by an entity of the government of the country;
``(ii) that authorize the approval of only those drugs that
have been determined to be safe and effective by experts
employed by or acting on behalf of such entity and qualified
by scientific training and experience to evaluate the safety
and effectiveness of drugs on the basis of adequate and well-
controlled investigations, including clinical investigations,
conducted by experts qualified by scientific training and
experience to evaluate the safety and effectiveness of drugs;
``(iii) that require the methods used in, and the
facilities and controls used for the manufacture, processing,
and packing of drugs in the country to be adequate to
preserve their identity, quality, purity, and strength;
``(iv) for the reporting of adverse reactions to drugs and
procedures to withdraw approval and remove drugs found not to
be safe or effective; and
``(v) that require the labeling and promotion of drugs to
be in accordance with the approval of the drug.
``(B) The valid marketing authorization system in the
country is equivalent to the systems in the countries
described in paragraphs (1) through (5).
``(C) The importation of drugs to the United States from
the country will not adversely affect public health.''.
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