Food and Drug Administration (FDA): Overview and Issues (CRS Report for Congress)
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| Release Date |
Revised June 18, 2009 |
| Report Number |
RS22946 |
| Report Type |
Report |
| Authors |
Erin D. Williams |
| Source Agency |
Congressional Research Service |
| Older Revisions |
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Summary:
Congress is interested in the issues surrounding the authorities, functioning, and budget of the
Food and Drug Administration (FDA) for a range of reasons. The agency has a relationship to at
least two broad legislative topics on Congress’s radar: health reform and globalization. In
addition, congressional oversight of the agency affects areas of public concern, such as food
safety and the regulation of medical products. This report provides background information
essential to understanding the issues for Congress, and provides an overview of those issues.
The FDA, an agency within the Department of Health and Human Services (HHS), regulates a
wide range of products valued at more than $1 trillion. The agency is responsible for the safety of
most foods (human and animal) and cosmetics, and it regulates both the safety and the
effectiveness of human drugs, biologics (e.g., vaccines, blood, and blood components), medical
devices, and animal drugs. In many cases, its responsibilities border those of other agencies. (See
Appendix A.) In such cases, interagency agreements may define the regulatory boundaries.
The primary law authorizing FDA activities is the Federal Food, Drug, and Cosmetic Act
(FFDCA; 21 USC Chapter 9). (See Appendix B.) FDA is also responsible for implementing
provisions in other laws, most notably the Public Health Service Act (PHSA; 42 USC Chapter
6A). For example, FDA’s authority to regulate most human biologics flows both from the PHSA
(§351), and from the FFDCA.
FDA has three offices that perform agency-wide functions. The Office of the Commissioner (OC)
conducts overall agency coordination. The Commissioner, FDA’s top official, requires Senate
confirmation. The Office of Chief Counsel handles the agency’s legal needs. FDA’s largest office,
the Office of Regulatory Affairs (ORA), handles FDA’s inspection and enforcement activities. It
employs about one-third of the agency’s personnel. Its inspection personnel are largely fungible,
meaning that the same cadre of employees at different times conducts inspections related to food,
drugs, or any other products FDA regulates.
FDA’s product-specific regulatory responsibilities are handled by five centers: the Center for
Biologics Evaluation and Research (CBER); the Center for Devices and Radiological Health
(CDRH); the Center for Drug Evaluation and Research (CDER); the Center for Food Safety and
Applied Nutrition (CFSAN); and the Center for Veterinary Medicine (CVM). A sixth center, the
National Center for Toxicological Research (NCTR), conducts scientific research and provides
expert technical advice and training that inform FDA’s science-based regulatory decisions. For
combination products (those spanning more than one category, such as drug-device, drugbiologic,
and device-biologic products), the review process is conducted by a product-specific
center, but assigned and coordinated by the Office of Combination Products, which is housed
within the OC.
The House and Senate Appropriations Committees’ Subcommittees on Agriculture, Rural
Development, Food and Drug Administration, and Related Agencies have jurisdiction over FDA’s
appropriations. FDA’s budget consists of two types of funds: public funds appropriated by
Congress (called budget authority or direct appropriations), and private (i.e., industry) funds
(called user fees).
