Alliance advocates for FDA budget 

Alliance for a Stronger FDA’s Steven Grossman argues Congress must fund agency as a public good

FDA may be the only regulatory agency in the U.S. that has the strong support of regulated industry, consumer groups and stakeholders such as patient groups and physicians.

The Alliance for a Stronger FDA, which brings together patient and consumer groups, biomedical research advocates, trade associations and companies, epitomizes the eclectic support FDA enjoys.

Congress hasn’t hesitated to add to FDA’s mission over the years, but it hasn’t always been eager to give it new resources. The alliance has adopted a strategy of advocating for FDA funding, and staying away from pushing specific policies.

In addition to influencing and educating Congress, the alliance and its executive director, Steven Grossman, have become the go-to source for those seeking to understand the often arcane intricacies of FDA budgeting. 

The alliance, which reported $260,000 in annual lobbying expenses in 2021 and 2022, is working to persuade Congress that it should continue to fund FDA’s needs. It brings together groups that often don’t agree, medical products manufacturers, consumer groups, patient advocates and others, to make the case to Congress for FDA funding. The alliance also sponsors webinars with senior FDA officials to inform Congress, the media and stakeholders about the agency’s work.

BioCentury sat down with Grossman to discuss the alliance and the FDA budget. The conversation, edited for clarity, follows.

BioCentury: What are the operating principles of the alliance?

Steven Grossman: The alliance was founded 16 years ago based on three basic principles, all of which we still follow today. First, we advocate for the entirety of FDA’s resource needs and thus welcome all stakeholders.

Second, we believe that a rising tide lifts all boats. The American people want an FDA that works across the board, not an agency that is muscular in one area and dangerously thin elsewhere.

Third, we focus on appropriations — where we have unanimity — and stay out of policy and product, where we clearly don’t. Congressional offices aren’t used to meeting with consumers and industry together, no less having both advocate for more resources for a federal regulatory agency.  

One of the oldest and most successful D.C. strategies — strange bedfellows — is to present your case with interests that are viewed as otherwise in opposition. That is inherent in the alliance membership and structure.

This approach also reinforces one of our key messages — FDA has a different mission and set of responsibilities than other regulatory agencies. There can be an Alliance for a Stronger FDA, but it is almost impossible to imagine a similar Alliance for a Stronger SEC or for a Stronger EPA.

BioCentury: Congress is in the middle of consideration of the FY24 budget. Where do things stand?

Grossman: Things are off to a rocky start but should become much clearer once Congress and the president agree on a package of increased borrowing authority and spending parameters for FY24, and perhaps continued into subsequent years.

In FY23, FDA is receiving $3.5 billion in budget authority appropriations. BA is the fancy name for taxpayer-funding as distinct from user fees. The opening salvo for FY24 is the recent mark-up of the House Appropriations Committee’s Ag/FDA subcommittee. They are proposing to level-fund the agency for FY24.

This runs counter to the alliance’s FY24 ask, which is for a BA appropriation of $3.9 billion. Our ask is consistent with the president’s request and with the need for FDA’s appropriation to reflect its expanding mission and growing responsibilities.

We point to increased complexity of science; progress in science, technology, and innovation; continued growth of FDA-regulated industries, including globalization; and the addition of new FDA responsibilities regularly, some based on legislation, some based on clear public health needs and challenges.

The House subcommittee mark-up is a starting point for the FY24 funding cycle. It is a long process, and the final appropriations bill is likely to be different in both amount and terms.

Even still, level funding does not mean FDA will actually have the same monies to spend in FY24. There are fixed cost elements in the administration’s proposal, notably about $100 million for mandated salary increases. The agency will have to absorb those if it isn’t given additional monies above the FY23 level.

BioCentury: Congress is considering maintaining flat funding for FDA in FY24 by using unobligated COVID funds. You’ve pointed out that this would cause a major problem starting in FY25. Can you explain that?

Grossman: The concern is larger than FDA but could have enormous impact on the agency. As initially proposed in the House subcommittee mark-ups, FY24 funding would be paid for in part by the recovery of unspent monies, notably unspent pandemic funding.

To produce nearly level funding for most of its programs, the House Ag/FDA subcommittee needs about $24 billion. For FY24, they proposed to do that with a base of about $16 billion and by recovering about $8 billion in unspent monies. But you can only spend them once. It seems probable this would create an FY25 base of $16 billion, about a third less than it is now.

To be clear, the House Ag/FDA subcommittee bill is not going to be the final one and a lot of changes can be expected. However, replacing part of base funding with one-time monies is a concept that could make FY24 look close to normal, but embedding a situation for next year where cuts might be unavoidable.  

BioCentury: That’s the longer-term scenario. What happens to FDA immediately if there is a default?

Grossman: We have a lot of experience with the rules for FDA during shutdowns, but no experiences of FDA in a default.

In a shutdown, FDA can retain essential and emergency personnel and can also spend user fees with limitations. Note that in a shutdown, the agency does not accept new product applications and can only spend user fees collected before the shutdown. After a certain number of weeks, the already-collected funds run out and there is then no distinction between work funded through BA appropriations and work funded through user fees — it all shuts down.

As I understand it, the BA/user fee distinction does not exist in a default. The limiting fact is the Treasury’s ability to pay money out of cash on hand. Neither Social Security nor user fees are protected by being held in separate accounts by the Treasury.

As with a shutdown, essential and emergency personnel would presumably still need to work if there is a default.

As a very general matter, essential personnel is a functional designation, not a statement of importance. So, categories of essential personnel are skewed toward patient care, facility and IT security, and maintenance of animal populations.

Beyond that, I would expect some statement of ground rules from OMB about four days or so before a potential default. Until then, we are only guessing about the nuances.

BioCentury: How do you get your message through in the current political environment?

Grossman: The alliance has two primary activities: advocating to Congress and policymakers for increased appropriated resources for FDA and educating policymakers, media and the public about FDA’s expanding mission and growing responsibilities. 

To accomplish these, the alliance provides analytic expertise and narrative communications to Congress and the media on why FDA is important and why resource needs keep growing.

The alliance’s case to Congress, the media, and the public is based on the exceptional importance of what FDA does and the consequences if the agency is not funded sufficiently for it to succeed.

We have intensified our educational and other outreach efforts to reflect the worsening budgetary environment and to remind all stakeholders that the FDA is a transformational part of public health and medicine and an incredibly large part of commerce.