Questions (and Answers) About Current Political Issues

Q: If the reconciliation bill becomes law, are FDA’s funding needs taken care of?
 
A: Not at all. Having the agency’s COVID-related resource needs covered by reconciliation -- which is extremely important -- does not lessen the budget and personnel needed to fulfill the agency’s mission and carry out its responsibilities. COVID apart, FDA’s mandate in FY 22 will be larger than it was in FY 20 or FY 21.  
 
Why this is so ,,, was covered at length in last week’s Analysis and Commentary (here). To recap the major points:

• No federal agency has a broader range of responsibilities than the FDA;
• No federal agency’s mission and responsibilities are more affected by changes in science, technology, innovation, and social trends than the FDA.

For example, FDA has approved 19 cell and gene therapies (here), but now must manage more than 900 INDs in this segment. A large portion of those INDs involve cutting-edge science. For another example, FDA’s  New Era of Smarter Food Safety (here) is premised on the prediction that the food system will see more changes “over the next 10 years than we have in decades.”
 
Q: At Secretary-Designate Becerra’s confirmation hearings, it was pointed out that he does not have a healthcare or science background. Should this concern FDA or the other Public Health Service agencies?
 
A: Since the creation of the Department of Health, Education and Welfare in 1953 (and its successor the Department of Health and Human Services in 1980), the Department has been led by individuals with medical, public health, or scientific training only three times. Dr. Otis Bowen (physician, also a former governor) was Secretary from 1985 to 1989 and was succeeded by Dr. Louis Sullivan (physician, also a senior leader of an academic institution) from 1989 to 1993. Dr. Tom Price (physician, also a former Member of Congress) served briefly in 2017. Perhaps not surprisingly, almost all other Secretaries of the Department had similar backgrounds but without medical degrees: governors, senior leaders of academic institutions, members of Congress, and veterans of the Executive Branch.
 
That is to say that FDA (and the other Public Health Service agencies) can expect to have the same range of experiences -- good and bad, smooth and frustrating -- with the new Secretary as they have had with prior Secretaries. Secretaries turn to their agency heads for advice and leadership. There are also individuals with medical and life sciences backgrounds in the Secretary’s staff offices.
 
To be clear: this is not commentary on the nomination of Secretary-Designate or a prediction of likely relationships. It is merely an answer to the question: Is there an issue for FDA because the Secretary-Designate lacks medical or scientific training. Historically, the answer is “No.”

Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.