Congressional Oversight of FDA

By Mark Land, M.S., RAC, AAHP President 

FDA interacts with Congress in many ways. It deals with two legislative committees: 1) the House Committee on Energy and Commerce’s Subcommittee on Health, and 2) the Senate Committee on Health, Education, Labor and Pensions. It deals with two other committees for its annual appropriations: 1) the House Committee on Appropriations’ Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and 2) the Senate Committee on Appropriations’ Subcommittee on Agriculture Rural Development Food and Drug Administration and Related Agencies. In total, FDA interacts with nearly a dozen congressional committees that take an active interest in the agency’s affairs. 

Controversial decisions by FDA or claims of procedural irregularities can quickly result in a hearing before one of these committees, at which time the responsible agency officials are called to account. Such hearings usually receive mainstream news media coverage. Frequently, Members of Congress and their staff pinpoint lower echelon FDA officials who are responsible for a given action and invite them into the spotlight of the hearing room. Not surprisingly, this oversight encourages risk-averse behavior on the part of FDA officials well down on the bureaucratic ladder. 

FDA manages its relationship with Congress via its Office of Legislation. The Office of Legislation directs and manages FDA interactions with Congress; ensures that Congress has the most accurate and up-to-date information regarding FDA regulatory actions; coordinates legislative activities with the Department of Health and Human Services; and manages FDA’s response to requests from the various entities that serve Congress (CRS, CBO, and GAO). 

In addition, the Office of Legislation serves as the focal point for overall legislative liaison activities within FDA and between FDA, HHS, and other agencies; analyzes the legislative needs of FDA; and drafts or develops legislative proposals, position papers, and departmental reports on proposed legislation for approval by the Commissioner. 

As mentioned above, in general Congress oversees FDA in both a policy and financial manner. Policy is managed by both the Senate HELP Committee and the House Energy and Commerce Committee. Financial oversight is managed by both the House and Senate Appropriations Committees. While AAHP occasionally engage with the appropriations committees, most often we interact with members of the committees that manage policies. 

The members and leadership of committees are dictated by the political composition of the legislature. Currently the Senate is under Democratic control, so the Chair of the HELP committee is a Democrat. The House is under Republican control, therefore the Chair of the House Energy and Commerce Committee is a Republican. AAHP works in a bipartisan manner and maintains relationships with both Republican and Democratic members of these committees. 

Since 1992, legislation affecting FDA has arisen either to support user fees for regulated products or larger health-related issues aside from user fee authorization. User fee legislation is generally reauthorized for 5-year periods of time. This legislation allows FDA to collect user fees to support FDA’s review of marketing applications for various types of products, including drugs (innovative and generic) and medical devices among others. Because legislation of this type is “must pass,” that is to say it must pass to keep FDA in operation, often other health-related initiatives become included in user fee reauthorization legislation. In this way congress and FDA can direct policy in a broader dimension related to health. 

In some cases, user fee reauthorization legislation is insufficient or not timely to address initiatives of congress or newly arisen health-related issues in American society. Thereby requiring specific legislation. For example, the 21st Century Cures Act (Cures Act) of December 13, 2016 is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. More recently although not specific to FDA-related matters, the Coronavirus Aid, Relief, and Economic Security (CARES) Act of March 27, 2020 directed FDA to revise the OTC monograph system. 

It is important to note that legislative initiatives require the cooperation of both FDA and the regulated community to be successful. For this reason, AAHP works within this larger framework of legislative vehicles and committee structures and FDA to make efficient use of our collective resources.