[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. Res. 97 Introduced in Senate (IS)]

113th CONGRESS
  1st Session
S. RES. 97

       Expressing the sense of the Senate that the Food and Drug 
Administration should encourage the use of abuse-deterrent formulations 
                               of drugs.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 15, 2013

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

_______________________________________________________________________

                               RESOLUTION


 
       Expressing the sense of the Senate that the Food and Drug 
Administration should encourage the use of abuse-deterrent formulations 
                               of drugs.

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
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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