Highlights from the Past Week

Q: What were some of the highlights from Dr. Woodcock’s remarks to the Alliance?

A: Dr. Woodcock covered a lot of ground in responding to more than 30 questions. It is well worth your time to listen to the entire 40 minutes of Dr. Woodcock’s remarks here.

Dr. Woodcock was asked: “Has the agency’s budget kept up with the demands placed on it?" To this, she replied, “No.” She cited inflationary costs, particularly on the personnel side but also in the capital budget. Further, facilities need to be maintained and upgraded and cannot be depreciated as in private companies.

Dr. Woodcock was asked: "What are FDA’s plans for spending the $500 million from the recent COVID relief bill?" To this, she replied, “We are grateful for Congress’ support on this.” Much of the money will be spent on surveillance -- pre-market, EUA, and eventually post-market. Other funds will be devoted to shortening supply chains and encouraging advanced manufacturing that can be rapidly scaled up to meet new needs. She also indicated that the agency has a recovery plan to address work backlogs and getting inspections back on track.

Dr. Woodcock was asked: “With COVID and breakthrough bioscientific advances commanding so much bandwidth, is there a risk that the food safety and veterinary medicine budgets will be neglected?” To this, she replied strongly: “Not on my watch.” She believes that all of FDA’s programs serve a valuable purpose and food safety is critical. Her goal is to be an advocate for the entire agency.

Q: How did the Alliance respond to the President’s Budget Preview?

A: While we were hoping for some insight into the administration’s position on FDA funding, the only thing that matters is what is in the full Request, expected to be released in May. The full President’s Budget Request will have the funding tables and more than 300 pages of details.

Meantime, the Alliance released the following statement:

Major new investments in FDA are justified and we are hopeful that will be reflected in the full budget request. Until that document is released, the answer to virtually all budget questions will fall into the category of “not enough information to know or even knowledgeably speculate.

Q: What is ARPA-H and what does the Biden administration hope it will accomplish?

A: The Advanced Research Program Agency -- Health (ARPA-H) is a major biosciences initiative that President Biden hopes Congress will adopt. He has recommended that it be initially funded with $6.5 billion in FY 22. The basic concept is to create a translational research entity in the biosciences, modeled on the Defense Department’s highly-successful DARPA program. It is to be housed at NIH, but presumably have a degree of independence as it focuses on higher risk translational research and would be built around contracts and project managers, rather than grants and peer review committees. A good article on the proposal is in Science magazine (here).

Increased investment in translational research is considered valuable and needed, especially if its initial focus is on diseases such as cancer and Alzheimer’s. However, the ARPA-H concept is likely to go through changes before it would be adopted, funded, and implemented, so we will be watching it closely. In particular, it is unclear whether FDA would have a role and whether FDA’s workload might markedly increase as a result of ARPA-H.

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