FDA-Related Legislation and Budgetary Implications

Every week seems to bring the introduction of more FDA-related legislation. It sometimes seems like every Member of Congress has their own ideas about how to improve or expand the agency’s operations.

On balance, we see far more good than bad in the breadth and depth of Congressional interest in FDA. For certain, we would be concerned if Congress ignored the agency and didn’t understand its importance.While the Alliance does not weigh in on which new responsibilities Congress should add to the agency, we are there to encourage discussion of what the resource implications will be with new responsibilities. Historically, most authorizing bills created new responsibilities without the funding to carry them out. In many situations, this created unfunded mandates. The authorizers’ solutions from the last year became the appropriators’ problems the next year.

Over the last few years, we have seen a new trend developing. Sponsors of FDA authorizing legislation are acknowledging that additional funds will be needed if their bill(s) become law. In some instances, the authorizers are even including funding in the legislation. In the case of House Cures legislation, the committee voted $10 billion in mandatory funding for NIH and FDA over 5 years, with about $155 million going to FDA each year. In the case of the Senate Innovations legislation, the minority has proposed $5 billion per year for 10 years in mandatory funding, with NIH and FDA splitting the money proportionally to their overall appropriation. The majority has acknowledged the new burdens that would be placed on FDA without endorsing the minority proposal.There is certainly a long way to go in the legislative and budgetary process before we can know the legislative outcome of these proposals. Because of the diversity of our membership, we carefully stay within our mission of advocating for more appropriated resources for the agency, and not advocating on the authorizing side.However, the contrast with the past is useful to point out. Four years ago, the FDASIA legislation contained a large number of non-user fee changes. There was discussion of the resource burden being placed on the agency, but no commitments other than general statements of sentiment for the appropriations committees to provide more moniesEven this general acknowledgement represented significant progress over 8 to 10 years ago. Back then, FDA was going through a difficult period with problems, particularly recalls and product withdrawals. At the time, there was even some sentiment that “FDA is not doing a good job, and let’s cut their budget to get their attention.” The Alliance was created in part to clarify: problems were a result of too little money, not poor use of existing appropriations.

Through our collective effort, we were successful in reversing this negative view of the agency 10 years ago, and are pleased to see that Congress has moved toward the realization that additional work requirements cost additional money. Because of how the system is set up, with authorizers and appropriators having distinct responsibilities, FDA may still suffer unfunded FDA mandates, but it is no longer the prevailing view that it should.

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