CRS Issue Statement on Drugs, Biologics, and Medical Devices

Erin D. Williams, Coordinator
Specialist in Public Health and Bioethics


The Food and Drug Administration (FDA) is the federal agency responsible for ensuring that drugs, vaccines and other biologics, and medical devices sold in the United States are safe and effective. These products generally require FDA's prior and continuing permission to be marketed. Ideally, the agency's actions must be sufficient to ensure that vital new medical products are indeed safe and effective, but not so rigorous and burdensome as to delay or prevent the public's access to such products.

In 2007, Congress enacted a major FDA reform and reauthorization law: the Food and Drug Administration Amendments Act of 2007 (FDAAA; P.L. 110-85). FDAAA reauthorized FDA's authority to collect industry user fees for human drugs and devices that help pay for its regulatory activities. Among many other provisions, FDAAA also strengthened the agency's authority over drug safety, created new incentives for the development of pediatric medical devices, and mandated the public disclosure of clinical trials data.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which gave the FDA regulatory authority over tobacco products. Among other responsibilities, the Family Smoking Prevention and Tobacco Control Act requires tobacco product manufacturers to register with FDA, replaces existing health warning labels with larger labels, requires the FDA to establish good manufacturing practices for tobacco product manufacturers, and mandates that tobacco product manufacturers seek FDA approval before marketing tobacco products with reduced-risk or reduced-exposure claims, such as the descriptors "light," "mild," and "low."


Date of Report: January 14, 2010
Number of Pages: 5
Order Number: IS40296
Price: $7.95
 
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