GovTrack’s Bill Summary
We don’t have a summary available yet.
Library of Congress Summary
The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.
Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics within the Food and Drug Administration (FDA). Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by:
(1) conducting postmarket risk assessment and surveillance of such drugs and products;
(2) determining whether a postmarket study is required;
(3) contracting, or requiring the sponsor of such a drug or product to contract, with the holders of domestic and international patient databases to conduct epidemiologic and other observational studies;
(4) determining whether a drug or product may present an unreasonable risk to the health of patients or the general public;
(5) taking corrective action if such an unreasonable risk may exist; and
(6) making information about the safety and effectiveness of such drugs and biological products available to the public and health care providers in a timely manner.
Requires the Drug Safety and Risk Management Advisory Committee to make recommendations to the Director on postmarket studies, drugs and biological products that may present an unreasonable risk, and appropriate corrective actions.
Allows the Secretary of Health and Human Services to assess civil penalties for violations of this Act. Allows the Director to withdraw or suspend approval of a drug or license for a biological product using expedited procedures under certain circumstances.
Transfers to the Center the functions and duties of the Office of Surveillance and Epidemiology.
House Republican Conference Summary
The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.
No summary available.
House Democratic Caucus Summary
The House Democratic Caucus does not provide summaries of bills.
So, yes, we display the House Republican Conference’s summaries when available even if we do not have a Democratic summary available. That’s because we feel it is better to give you as much information as possible, even if we cannot provide every viewpoint.
We’ll be looking for a source of summaries from the other side in the meanwhile.