[Congressional Record (Bound Edition), Volume 159 (2013), Part 4]
[Senate]
[Pages 5195-5196]
[From the U.S. Government Publishing Office, www.gpo.gov]




                         SUBMITTED RESOLUTIONS

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SENATE RESOLUTION 97--EXPRESSING THE SENSE OF THE SENATE THAT THE FOOD 
  AND DRUG ADMINISTRATION SHOULD ENCOURAGE THE USE OF ABUSE-DETERRENT 
                         FORMULATIONS OF DRUGS

  Mr. COBURN (for himself, Mr. Schumer, and Mr. McConnell) submitted 
the following resolution; which was referred to the Committee on 
Health, Education, Labor, and Pensions:

                               S. Res. 97

       Whereas when abuse-deterrent formulations of a drug have 
     been developed, approved, and recognized as effective by the 
     Food and Drug Administration, the approval and marketing of 
     generic versions that do not have abuse-deterrent features 
     are likely to prevent achievement of the public health 
     purposes of the efforts to develop such abuse-deterrent 
     formulations;
       Whereas the Office of National Drug Control Policy and the 
     Food and Drug Administration have for many years strongly 
     encouraged manufacturers of opioid drug products to develop 
     abuse-deterrent formulations designed to prevent or 
     discourage the abuse or misuse of those products;
       Whereas in response, several opioid drug manufacturers have 
     developed abuse-deterrent formulations;
       Whereas efforts to reduce the level of abuse of opioid drug 
     products are dependent on the widespread adoption of new 
     technologies and approaches to the safer formulation of these 
     drugs; and

[[Page 5196]]

       Whereas the Commissioner of Food and Drugs has acknowledged 
     that the Food and Drug Administration has the authority under 
     current law to require generic versions of products that have 
     been formulated or reformulated with abuse-deterrent features 
     to have comparable features: Now, therefore, be it
       Resolved, That it is the sense of the Senate that the Food 
     and Drug Administration should exercise its acknowledged 
     authority to--
       (1) refuse to approve generic versions of non-abuse-
     deterrent opioid products that have been replaced in the 
     market with abuse-deterrent formulations recognized by the 
     Food and Drug Administration as effective; and
       (2) require generic versions of abuse-deterrent opioid 
     products to be formulated with comparable abuse-deterrent 
     features.

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