[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Page 11646]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 1061. Mr. DORGAN (for himself and Ms. Snowe) submitted an 
amendment intended to be proposed by him to the bill S. 1082, to amend 
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the 
prescription drug user fee provisions, and for other purposes; which 
was ordered to lie on the table; as follows:
       At the appropriate place in the amendment, insert the 
     following:

     SEC. __. COUNTRY OF ORIGIN LABELING ON PRESCRIPTION DRUGS.

       (a) In General.--Not later than 90 days after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall issue regulations to require that the 
     labeling, including retail packaging, of each prescription 
     drug include the name of the country in which such 
     prescription drug was manufactured.
       (b) Definition.--In this section, the term ``labeling'' has 
     the meaning given such term in section 201(m) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 321(m)).
                                 ______
                                 
  SA 1062. Mr. DORGAN (for himself and Ms. Snowe) submitted an 
amendment intended to be proposed by him to the bill S. 1082, to amend 
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the 
prescription drug user fee provisions, and for other purposes; which 
was ordered to lie on the table; as follows:

       At the appropriate place in the amendment, insert the 
     following:

     SEC. __. CERTIFICATION OF SAFETY FOR NEW PRESCRIPTION DRUGS.

       Notwithstanding any other provision of law, the Secretary 
     of Health and Human Services shall certify, prior to the 
     approval for marketing of any new prescription drug under 
     section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355), that the approval of such drug poses no 
     additional risk to the public's health and safety.
                                 ______
                                 
  SA 1063. Mr. DORGAN (for himself and Ms. Snowe) submitted an 
amendment intended to be proposed by him to the bill S. 1082, to amend 
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the 
prescription drug user fee provisions, and for other purposes; which 
was ordered to lie on the table; as follows:

       At the appropriate place in the amendment, insert the 
     following:

     SEC. __. COUNTERFEIT-RESISTANT TECHNOLOGIES.

       (a) In General.--Notwithstanding any other provision of 
     this Act, the requirement that the Secretary of Health and 
     Human Services certify that the implementation of the title 
     of this Act relating to the Importation of Prescription Drugs 
     will pose no additional risk to the public's health and 
     safety and will result in a significant reduction in the cost 
     of covered products to the American consumer shall not apply 
     to the requirement that the Secretary, not later than 18 
     months after the date of enactment of this Act, require that 
     the packaging of any prescription drug incorporates--
       (1) a standardized numerical identifier unique to each 
     package of such drug, applied at the point of manufacturing 
     and repackaging (in which case the numerical identifier shall 
     be linked to the numerical identifier applied at the point of 
     manufacturing); and
       (2)(A) overt optically variable counterfeit-resistant 
     technologies that--
       (i) are visible to the naked eye, providing for visual 
     identification of product authenticity without the need for 
     readers, microscopes, lighting devices, or scanners;
       (ii) are similar to that used by the Bureau of Engraving 
     and Printing to secure United States currency;
       (iii) are manufactured and distributed in a highly secure, 
     tightly controlled environment; and
       (iv) incorporate additional layers of nonvisible convert 
     security features up to and including forensic capability, as 
     described in subsection (b); or
       (B) technologies that have a function of security 
     comparable to that described in subparagraph (A), as 
     determined by the Secretary.
       (b) Standards for Packaging.--For the purpose of making it 
     more difficult to counterfeit the packaging of drugs subject 
     to this section, the manufacturers of such drugs shall 
     incorporate the technologies described in subsection (a) into 
     at least 1 additional element of the physical packaging of 
     the drugs, including blister packs, shrink wrap, package 
     labels, package seals, bottles, and boxes.
                                 ______
                                 
  SA 1064. Mr. SESSIONS submitted an amendment intended to be proposed 
to amendment SA 1059 submitted by Mr. Sessions (for himself, Mrs. 
Lincoln, Mr. Cochran, Mr. Pryor, Mr. Lott, and Mr. Shelby) and intended 
to be proposed to the bill S. 1082, to amend the Federal Food, Drug, 
and Cosmetic Act to reauthorize and amend the prescription drug user 
fee provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 1 of the amendment, strike line 4 and all that 
     follows through line 7 on page 2, and redesignate the 
     remaining subsections accordingly.

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