[Congressional Record Volume 162, Number 32 (Monday, February 29, 2016)]
[Senate]
[Page S1092]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 3329. Mr. DURBIN submitted an amendment intended to be proposed by 
him to the bill S. 524, to authorize the Attorney General to award 
grants to address the national epidemics of prescription opioid abuse 
and heroin use; which was ordered to lie on the table; as follows:

       At the end of title I, add the following:

     SEC. 104. OPIOID ACTION PLAN.

       (a) Advisory Committee.--
       (1) New drug application.--Except as provided in paragraph 
     (4), prior to the approval of a new drug that is an opioid 
     under section 505 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355), the Commissioner of Food and Drugs shall 
     refer such drug to an advisory committee of the Food and Drug 
     Administration to seek recommendations from such Committee.
       (2) Pediatric opioid labeling.--The Commissioner of Food 
     and Drugs shall convene the Pediatric Advisory Committee of 
     the Food and Drug Administration to seek recommendations from 
     such Committee regarding a framework for the inclusion of 
     information in the labeling of drugs that are opioids 
     relating to the use of such drugs in pediatric populations 
     before such Commissioner approves any labeling changes for 
     drugs that are opioids intended for use in pediatric 
     populations.
       (3) Public health exemption.--If the Commissioner of Food 
     and Drugs finds that referring a new opioid drug or drugs to 
     an advisory committee of the Food and Drug Administration as 
     required under paragraph (1) is not in the interest of 
     protecting and promoting public health, and has submitted a 
     notice containing the rationale for such a finding to the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Committee on Energy and Commerce of the House 
     of Representatives, or if the matter that would be considered 
     by such advisory committee with respect to any such drug or 
     drugs concerns bioequivalence or sameness of active 
     ingredients, the Commissioner shall not be required to refer 
     such drug or drugs to an advisory committee as required under 
     paragraph (1).
       (4) Sunset.--Unless Congress reauthorizes paragraphs (1) 
     and (2), the requirements of such paragraphs shall cease to 
     be effective on October 1, 2022.
       (b) Continuing Medical Education for Prescribers of 
     Opioids.--Not later than 1 year after the date of enactment 
     of this Act, the Secretary of Health and Human Services, 
     acting through the Commissioner of Food and Drugs, in 
     consultation with the Director of the Centers for Disease 
     Control and Prevention, the Director of the National 
     Institutes of Health, the Administrator of the Agency for 
     Healthcare Research and Quality, the Administrator of the 
     Drug Enforcement Administration, and relevant stakeholders, 
     shall develop recommendations regarding continuing medical 
     education programs for prescribers of opioids required to be 
     disseminated under section 505-1 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355-1), including recommendations 
     for which prescribers should participate in such programs and 
     how often participation in such programs is necessary.
       (c) Guidance.--Not later than 1 year after the date of 
     enactment of this Act, the Commissioner of Food and Drugs 
     shall issue guidance on if and how the approved labeling of a 
     drug that is an opioid and is the subject of an application 
     under section 505(j) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(j)) may include statements that such drug 
     deters abuse.
                                 ______