House Bills - 110th Congress

H. R. 3580 —The Food And Drug Administration Amendments Act of 2007

On September 19, 2007, Representative John Dingell (D-MI) introduced H.R. 3580, the Food and Drug Administration Amendments Act of 2007.  The bill represents the conference agreement for S. 1082, which passed the Senate on May 9, and H.R. 2900, which passed the House on July 11.  The bill is focused primarily on FDA and contains sections regarding user fees and drug safety monitoring procedures.   The bill also contains the following provisions of interest to NIH: (1) Title III would require NIH to expand research on pediatric medical devices; (2) Title V would reauthorize the Best Pharmaceuticals for Children Act; (3) Title VIII would expand the Clinicaltrials.gov registry to include mandatory reporting of certain drug and device clinical trials; and (4) Title XI would make technical changes to Title IV of the PHS Act, where NIH statutory authorities are located.  The bill would require the establishment within one year of a “basic results” database that would contain basic demographic information as well as information on primary and secondary outcome measures.  The Secretary would be charged with promulgating regulations within three years to expand the results database to include adverse event information, as well as additional summary information regarding results.  H.R. 3580 was referred to the House Committee on Energy and Commerce.

FLOOR ACTION

September 19, 2007 -  The House passed H.R. 3580 by a vote of 405-7 under suspension of the rules.

September 20, 2007 -  The Senate passed H.R. 3580 by unanimous consent.

PRESIDENTIAL ACTION

September 27, 2007 -  The President signed H.R. 3580 as P.L. 110-85.

Legislative Update (May 2008): The Food and Drug Administration Amendments Act of 2007