Senate Bills - 110th Congress

S. 1082—The Food and Drug Administration Revitalization Act

On April 10, Senator Edward Kennedy (D-MA) introduced S. 1082, the Food and Drug Administration Revitalization Act. A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes. S. 1082 was referred to the Senate Committee on Health, Education, Labor and Pensions (HELP).

COMMITTEE ACTION

On April 18, the Senate Committee on Health, Education, Labor and Pensions (HELP) (Senator Edward Kennedy [D-MA], Chairman, reported S. 1082, the Food and Drug Administration Revitalization Act, favorably with an amendment in the nature of a substitute. As amended, the bill would expand the Clinicaltrials.gov registry to include mandatory reporting of certain drug and device clinical trials. The bill would also require that the ClinicalTrials.gov website provide corresponding linkages to peer-reviewed literature and certain publicly available FDA information regarding the results of those trials. S. 1082 also includes provisions to reauthorize the Best Pharmaceuticals for Children Act.

FLOOR ACTION

On May 9, the Senate passed S. 1082, the Food and Drug Administration Revitalization Act. The bill is focused primarily on FDA and contains sections regarding user fees and drug safety monitoring procedures. As amended, the bill also contains several provisions of interest to NIH. First, the bill would expand the Clinicaltrials.gov registry to include mandatory reporting of certain drug and device clinical trials. The bill would also require that the ClinicalTrials.gov website provide corresponding linkages to peer-reviewed literature and certain publicly available FDA information regarding the results of those trials. Second, S. 1082 includes provisions to reauthorize the Best Pharmaceuticals for Children Act. Third, the bill contains provisions to expand research on pediatric devices. Finally, an amendment proffered by Senator Barack Obama (D-IL) was added during floor debate, which would require the Secretary to contract with the Institute of Medicine to make recommendations regarding oversight and regulation of genetic tests. S. 1082 was introduced on April 10, by Senator Edward Kennedy (D-MA), with strong support from Senator Mike Enzi (R-WY).