[Congressional Record (Bound Edition), Volume 159 (2013), Part 11]
[Senate]
[Pages 16490-16492]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 2007. Mrs. GILLIBRAND submitted an amendment intended to be 
proposed by her to the bill H.R. 3204, to amend the Federal Food, Drug, 
and Cosmetic Act with respect to human drug compounding and drug supply 
chain security, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end, add the following:

         TITLE III--USE OF ANTIMICROBIAL DRUGS IN FOOD ANIMALS

     SEC. 301. SHORT TITLE.

       This title may be cited as the ``Delivering Antimicrobial 
     Transparency in Animals Act of 2013''.

     SEC. 302. PURPOSE.

       The purpose of this title is to provide the Food and Drug 
     Administration and the public with better information on the 
     use of antimicrobial drugs in animals used for food to--
       (1) enable public health officials and scientists to better 
     understand and interpret trends and variations in rates of 
     microbial resistance to such antimicrobial drugs;
       (2) improve the understanding of the relationship between 
     antimicrobial drug use in animals used for food and 
     antimicrobial drug resistance in microbes in and on animals 
     and humans; and
       (3) identify interventions to prevent and control such 
     antimicrobial drug resistance.

     SEC. 303. RESEARCH PROGRAMS TO STUDY ANTIMICROBIAL 
                   RESISTANCE.

       (a) Definitions.--In this title--
       (1) the term ``Commissioner'' means the Commissioner of 
     Food and Drugs; and
       (2) the term ``Secretary'' means the Secretary of Health 
     and Human Services.
       (b) Establishment of Programs.--The Secretary, acting 
     through the Commissioner, shall develop a research program or 
     programs to study the relationship between the sales, 
     distribution, end-use practices of animal drugs containing an 
     antimicrobial active ingredient in food-producing animals and 
     antimicrobial resistance trends.
       (c) Purpose of Programs.--Any research program developed 
     under subsection (b) shall be developed in order to better 
     determine--

[[Page 16491]]

       (1) the relationships between sales data, distribution 
     data, and end-usage data of animal drugs containing an 
     antimicrobial active ingredient in food-producing animals to 
     inform policies of Food and Drug Administration regarding 
     data collection and regulation of antimicrobial products in 
     agriculture, including consideration of the potential value 
     of data from veterinary feed directives; and
       (2) the relationships between antimicrobial resistance and 
     use of animal drugs containing an antimicrobial active 
     ingredient in food-producing animals and trends in 
     antimicrobial resistance, including by using the data 
     collected through the National Antimicrobial Resistance 
     Monitoring Program or other studies regarding resistance 
     levels in bacteria associated with food-producing animals.
       (d) Consultation.--Any research program developed under 
     subsection (b) shall be developed in consultation with the 
     Under Secretary for Food Safety, the Under Secretary for 
     Marketing and Regulatory Programs, and the Under Secretary 
     for Research, Education, and Economics at the Department of 
     Agriculture. To the extent practicable, such Under 
     Secretaries shall provide assistance in developing and 
     conducting such research programs.
       (e) Implementation.--Not later than 1 year after the date 
     of enactment of this Act, the Secretary shall implement the 
     research program or programs developed under subsection (b). 
     The Secretary shall analyze data from such program or 
     programs to determine the contribution of such data to 
     studying antimicrobial resistance, protecting public health, 
     and establishing the coordinated data collection strategy as 
     described in section 305.
       (f) Publication.--The Secretary shall publish the results 
     of any research program developed under this section as soon 
     as practicable.

     SEC. 304. ENHANCED REPORTING AND PUBLICATION OF SALES DATA.

       (a) In General.--Section 512(l)(3)(E)) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360b(l)(3)(E)) is amended--
       (1) by redesignating clauses (i) and (ii) as subclauses (I) 
     and (II);
       (2) by striking ``The Secretary shall make summaries of the 
     information reported under this paragraph publicly available, 
     except that--'' and inserting ``(i) Not later than a date 
     established by the Secretary for 2014, and on such date in 
     each year thereafter, the Secretary shall make publicly 
     available a summary of the information (including dosage form 
     information, if practicable) reported under this paragraph 
     for the previous year, except that--''; and
       (3) by inserting after subclause (II), as redesignated by 
     paragraph (1), the following:
       ``(ii) In making the summaries available under this 
     subparagraph, the following shall apply:
       ``(I) The Secretary shall segregate the categories of 
     amounts reported into the following 2 subcategories, after 
     consultation with the applicable classifications of the World 
     Health Organization:
       ``(aa) The volume of drugs of importance to human medicine.
       ``(bb) The volume of drugs not of importance to human 
     medicine.
       ``(II) As practicable, the Secretary shall segregate 
     amounts reported into the following 2 amounts:
       ``(aa) The volume of drugs labeled or eligible for use in 
     food-producing animals.
       ``(bb) The volume of drugs that are not labeled or are 
     ineligible for use in food-producing animals.
       ``(III) In any cross-tabulation of the amounts reported 
     with any reporting category, the Secretary shall include the 
     categories `Not Independently Reported' and `Not 
     Independently Reported Export'.''.
       (b) Reissuance.--Not later than 3 years after the date of 
     enactment of this Act, the Secretary shall reissue the 
     summary reports issued before 2012 under section 512(l)(3)(E) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     360b(l)(3)(E)) using the format designed for the 2012 summary 
     report. The Secretary shall publish the reissued reports in 
     one combined publication.

     SEC. 305. IMPLEMENTATION AND PUBLICATION OF ANTIMICROBIAL 
                   RESISTANCE DATA COLLECTION STRATEGY.

       (a) In General.--Not later than 3 years after the date of 
     enactment of this Act, the Secretary, acting through the 
     Commissioner, shall implement an Antimicrobial Data 
     Collection Strategy, based on information received in the 
     comments to the Advanced Notice of Proposed Rulemaking 
     entitled ``Antimicrobial Animal Drug Distribution 
     Reporting''(77 Fed. Reg. 44177 (July 27, 2012)) and any 
     research program developed under section 303.
       (b) Reevaluation.--Not less than every 5 years after the 
     implementation of the Antimicrobial Data Collection Strategy 
     under subsection (a), the Secretary shall reevaluate such 
     Strategy and propose modifications as such Secretary 
     determines appropriate, based on scientific data.
       (c) Availability.--The Secretary shall--
       (1) submit to Congress the Strategy implemented under 
     subsection (a), and any modification made to such Strategy 
     pursuant to subsection (b); and
       (2) make such Strategy and any such modification available 
     to the public.

     SEC. 306. ACTION BY GOVERNMENT ACCOUNTABILITY OFFICE.

       (a) Publication of Final Guidance.--Not later than 180 days 
     after the date of enactment of this Act, the Secretary shall 
     publish a final version of the draft Voluntary Guidance #213 
     of the Food and Drug Administration (entitled ``New Animal 
     Drugs and New Animal Drug Combination Products Administered 
     in or on Medicated Feed or Drinking Water of Food-Producing 
     Animals: Recommendations for Drug Sponsors for Voluntarily 
     Aligning Product Use Conditions with GFI #209'').
       (b) Report by GAO.--
       (1) In general.--Not later than 3 years after the 
     publication of the final guidance described in subsection 
     (a), the Comptroller General of the United States shall 
     commence a study to evaluate--
       (A) the voluntary approach used by the Food and Drug 
     Administration to eliminate injudicious use of antimicrobial 
     drugs in food-producing animals; and
       (B) the effectiveness of the data collection activities 
     conducted by the Food and Drug Administration regarding 
     antimicrobial resistance.
       (2) Report.--Not later than 1 year after commencing the 
     study described in paragraph (1), the Comptroller General of 
     the United States shall submit to the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report that describes the results of such 
     study.
                                 ______
                                 
  SA 2008. Mrs. GILLIBRAND submitted an amendment intended to be 
proposed by her to the bill H.R. 3204, to amend the Federal Food, Drug, 
and Cosmetic Act with respect to human drug compounding and drug supply 
chain security, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end, add the following:

    TITLE III--PATIENT MEDICATION INFORMATION FOR PRESCRIPTION DRUGS

     SEC. 301. SHORT TITLE.

       This title may be cited as the ``Cody Miller Initiative for 
     Safer Prescriptions Act''.

     SEC. 302. PATIENT MEDICATION INFORMATION FOR PRESCRIPTION 
                   DRUGS.

       Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 351 et seq.) is amended by inserting after section 
     505E the following:

     ``SEC. 505F. PATIENT MEDICATION INFORMATION FOR PRESCRIPTION 
                   DRUGS.

       ``(a) In General.--Not later than 2 years after the date of 
     enactment of this section, the Secretary shall issue 
     regulations regarding the authorship, content, format, and 
     dissemination requirements for patient medication information 
     (referred to in this section as `PMI') for drugs subject to 
     section 503(b)(1).
       ``(b) Content.--The regulations promulgated under 
     subsection (a) shall require that the PMI with respect to a 
     drug--
       ``(1) be scientifically accurate and based on the 
     professional labeling approved by the Secretary and 
     authoritative, peer-reviewed literature; and
       ``(2) includes nontechnical, understandable, plain language 
     that is not promotional in tone or content, and contains at 
     least--
       ``(A) the established name of drug, including the 
     established name of such drug as a listed drug (as described 
     in section 505(j)(2)(A)) and as a drug that is the subject of 
     an approved abbreviated new drug application under section 
     505(j) or of an approved license for a biological product 
     submitted under section 351(k) of the Public Health Service 
     Act, if applicable;
       ``(B) drug uses and clinical benefits;
       ``(C) general directions for proper use;
       ``(D) contraindications, common side effects, and most 
     serious risks of the drug, especially with respect to certain 
     groups such as children, pregnant women, and the elderly;
       ``(E) measures patients may be able to take, if any, to 
     reduce the side effects and risks of the drug;
       ``(F) when a patient should contact his or her health care 
     professional;
       ``(G) instructions not to share medications, and, if any 
     exist, key storage requirements, and recommendations relating 
     to proper disposal of any unused portion of the drug; and
       ``(H) known clinically important interactions with other 
     drugs and substances.
       ``(c) Timeliness, Consistency, and Accuracy.--The 
     regulations promulgated under subsection (a) shall include 
     standards related to--
       ``(1) performing timely updates of drug information as new 
     drugs and new information becomes available;
       ``(2) ensuring that common information is applied 
     consistently and simultaneously across similar drug products 
     and for drugs within classes of medications in order to avoid 
     patient confusion and harm; and
       ``(3) developing a process, including consumer testing, to 
     assess the quality and effectiveness of PMI in ensuring that 
     PMI promotes patient understanding and safe and effective 
     medication use.

[[Page 16492]]

       ``(d) Electronic Repository.--The regulations promulgated 
     under subsection (a) shall provide for the development of a 
     publicly accessible electronic repository for all PMI 
     documents and content to facilitate the availability of 
     PMI.''.

     SEC. 303. PUBLICATION ON INTERNET WEBSITE.

       The Secretary of Health and Human Services shall publish on 
     the Internet website of the Food and Drug Administration a 
     link to the Daily Med website (http://dailymed
.nlm.nih.gov/dailymed) (or any successor website).

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