Resisting the Impulse to Cut FDA Funding During Times of Controversy

The Alliance was created 15 years ago, during a time when the FDA was under considerable (and constant) pressure from Congress. To “get FDA’s attention,” some in Congress were prepared to cut FDA’s already-bare bones budget further.

Alliance founders saw that as an existential threat to the agency and banded together to advocate for more FDA funding and to promote understanding of FDA’s mission and responsibilities.

Then, as now, if FDA fails to live up to its own high standards, it must work to do better. Every agency official is committed to doing that. In turn, Congress has an obligation to hold the agency accountable for making any necessary changes. It is in everyone’s interest that this be accomplished amicably and productively, not with threats.

FDA’s budget is devoted to promoting public health and safety to benefit the American public. There are hundreds of responsibilities and, inevitably, places where the resources are spread thin. Cutting the agency’s budget is to invite a thousand extra problems—throughout the agency--when it is more effective to focus on a few areas where problems exist.

There is a positive correlation between additional resources and strong leadership. While not all problems can be solved with money, there are few problems for which additional resources, wisely applied, cannot speed the path to resolution.

Given the breadth of its mission, cutting FDA is a blunt instrument that invites multiple failures; funding the FDA properly promotes the better FDA that we all seek.

A New Take on Understaffed FDA Offices

The Committee Report accompanying the House Ag/FDA FY23 appropriations bill is more than twenty pages long. Every paragraph is important to some stakeholder, as well as Congress.

However, our focus immediately turned to the first item in the report:

"This bill was developed during the infant formula shortage in the spring of 2022. That crisis revealed the FDA had only nine people in the office that regulates infant formula. This raises a concern about how many other key offices at the agency are also severely understaffed. The Committee will be in dialogue with the agency throughout the year about critical staffing needs."

The Alliance often talks about the number and breadth of FDA’s responsibilities. Given our view, we find it credible that there are many smaller FDA offices—with critical responsibilities--that are understaffed. A dialogue between FDA leadership and Congressional appropriators on this topic is a welcome development.

ARPA-H Passes House; Includes Reimbursement for FDA Activities.

The House passed ARPA-H legislation this week. At some point, we expect the Senate to consider its own version and eventually a conference version will become law. In the interim, monies and language in the FY 22 appropriations bill have allowed HHS to start implementation.

From the beginning, the Alliance has remained neutral on the legislation because it is clearly outside our mandate as an organization. However, we were concerned that early drafts of the legislation failed to recognize that a successful ARPA-H would require a large FDA commitment. We are pleased that the version passed by the House includes language that permits ARPA-H and FDA to agree upon reimbursement of costs FDA will incur in supporting ARPA-H.

Editorial Note: The week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.