Appropriators Are the First Priority, But ...

Bipartisan efforts to improve FDA have popped up from time to time over the last several decades. The current House Energy and Commerce Committee effort -- 21st Century Cures -- may be more extensive than some past efforts, but otherwise similar. The goal is generally the same and laudable: how to help FDA become more effective in carrying out its responsibilities for safe foods, safe and effective medical products, and fostering innovation. I think all of us who have worked at FDA or worked on FDA policy or regulated products look forward to constructive discussion of the Committee draft.This, of course, has nothing to do with the Alliance ... or does it? The Alliance is exclusively focused on supporting increased appropriated funding for the agency. That funding comes from the appropriating committees and indirectly, from the overall budget and spending policies adopted by Congress.

And yet, the Alliance cares very much what the authorizing committees think. Why? Because the laws that FDA carries out and enforces come from the authorizing committees. From them comes the FDA’s mission and identity. We cannot talk about FDA’s needs without reference to what the authorizing committee’s have said and legislated. In just the past 5 years, that would include (among other things) laws affecting tobacco, biosimilars, food safety, improvements in the drug and device review process, and drug compounding and security. What these committees think about FDA is actually quite central to the agency’s funding.

There is another important reason for the Alliance to keep talking with the authorizing committees: when they speak out about the need for additional resources for FDA, they have enormous credibility. Fellow Members of Congress listen.In this regard, the FDA (and the Alliance) are fortunate that so many members of the authorizing committees understand that giving FDA new responsibilities is counterproductive without the resources to implement. Some of our best advocates in Congress are on the House Energy and Commerce Committee and the Senate HELP Committee.

Reflecting this importance, the Alliance is (this very day) holding its first Congressional Staff briefing in a new series called “FDA 101: The Vital Role of the Food and Drug Administration in our Nation’s Public Health and Economy.” The House Energy and Commerce Committee is co-sponsoring the event. Aimed at congressional staff who have healthcare policy responsibility or have an interest in learning more about the agency, those participating in the briefing will gain an understanding of the structure of FDA regulation, the complex public health challenges the FDA is facing, and perspectives on the importance of FDA’s work from regulated industry, patient and consumer groups.All of this is to say: our first priority is appropriators, but authorizers follow close behind.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.