House Bills - 110th Congress

H.R. 1561—The Enhancing Drug Safety and Innovation Act of 2007

On March 19, 2007, Representative Henry Waxman (D-CA) introduced H.R. 1561, the Enhancing Drug Safety and Innovation Act of 2007. The bill is similar in structure and intent to S. 484, introduced by Senators Edward Kennedy (D-MA) and Michael Enzi (R-WY), but contains numerous technical differences. The bill is primarily aimed at modifying procedures at FDA regarding the approval of drugs. However, like S. 484, Title III of the bill would require NIH to expand ClinicalTrials.gov to include a broader registry of clinical trials. The bill would also require NIH to establish a “results” database which would require sponsors of clinical trials to submit results of those clinical trials included in the registry, accompanied by a narrative summary describing those results. The bill was referred to the House Committee on Energy and Commerce.

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