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.".


(As printed in the Congressional Record for the Senate on Oct 18, 2011.)