The good news is that the new Administration proposed a significant increase in aggregate funding for the FDA. In a budget in which almost all agencies faced large cuts, the strength of FDA’s mission and responsibilities led the new Administration to request a 9 percent — $452 million — increase. We think that’s exactly right and we love the message “FDA needs more resources!”  We applaud the Administration’s intent.

However, there is definitely bad news that might well overwhelm the good. The OMB proposal would cut $871 million from the agency’s budget authority (BA) appropriations, which is a 31 percent cut. This includes a $108 million cut in food funding, or 8 percent, a $705 million cut in medical product funding, or 52%, and a cut of about $50 million in activities that as far as we can tell are not characterized as food or medical product programs.

To lessen the blow on the food side, the Administration proposed a $54 million increase in animal drug and animal generic drug user fees. It is extremely unlikely that Congress will authorize these additional funds. To lessen the blow on the medical product side, the Administration is proposing a $1.2 billion dollar expansion of PDUFA, GDUFA, MDUFA, and BsUFA. That would roughly double the size of those programs. Congress has already made clear that they will not re-open the current re-authorization process to consider the proposed additional fees.

Apart from these practical reasons why expanded user fees won’t happen, there is also our concern that user fee funds should not be a substitute for budget authority funds. They serve different purposes. BA appropriations pay for fulfilling FDA’s mission and responsibilities. This includes safe and effective medical products and safe foods, and also a myriad of other Congressionally-mandated public health and consumer protection programs. The primary beneficiary is the public.

In contrast, user fees supplement the agency’s BA appropriation and pay for improvements; they were never intended to replace the agency’s BA appropriation. They result from carefully balanced negotiations in which FDA commits to undertake certain programs and meet certain metrics in exchange for the user fees that medical product industries have agreed to pay.

In sum, the pieces of the Administration proposal do not really fit together. As Ladd Wiley, our Executive Director, has been widely quoted as saying:

“The real practical problem here is that [the Administration proposal] is taking appropriations away and replacing it with something that’s not going to happen, and what we’re left with, is the taking away and a significant hole in the agency’s budget.”

What happens next? The House held its FDA appropriations hearing this week and we assume the Senate will do the same within the next month. In each subcommittee, staff will be discussing tentative funding levels for major agencies and programs.

However, the process can’t be completed until the Budget Committees determine the size of the federal budget in FY 18 and the full appropriations committees allocate that total amount among their 12 subcommittees. Subcommittee and committee mark-ups follow. This all will take some time, but can move remarkably quickly if a consensus forms. On the other hand, if it grows too contentious, there is the possibility that the process will grind to a halt.

So, the Alliance will be proceeding with urgency, working with Congress to find ways to support the agency in the new fiscal year. Expect additional action alerts and Hill meetings as we ask you to help spread the word.

Editor’s note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA

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President Donald Trump is proposing shifting $54 billion from domestic to defense programs in fiscal year 2018, which begins Oct. 1.

The proposal, unveiled in a speech to Congress on Feb. 28, calls for an approximate 10 percent increase for defense programs and an approximate 10 percent cut for non-defense discretionary programs. At this point we have no indication how the Food and Drug Administration would be treated in the president’s proposal. However, for reference purposes, a 10 percent cut in FDA’s appropriation would mean a loss of $272 million in program funds and take FDA back to approximately its FY 2012 level.

A number of non-defense programs are likely to be protected in the President’s proposal, such as veterans’ programs and border security. Thus, to pay for the defense build-up, the president’s proposal could well include cuts for non-protected programs that are closer to 12 percent to 14 percent. The percentage could be even higher if the president proposes that non-defense programs be cut further in order to pay for proposed new initiatives, such as the border wall or rebuilding our nation’s infrastructure.

While Congress has final say on appropriations, FDA stakeholders should be very concerned, but not panicked. What the president described is just a general proposal, to be fleshed out with more details when he sends his budget outline to Congress in mid-March and his complete budget proposal in late April or May. Congress will make the final decisions. However, regardless of the actual numbers in the president’s proposal, the tone and direction threatens FDA’s appropriation and the agency is at risk. We need to advocate for FDA to be one of those protected programs that are not subject to a 10 percent to 15 percent cut because they are considered a national priority.

As described in the Feb. 24 Analysis and Commentary from the Alliance for a Stronger FDA, there are really only two ways to pay for a defense build-up: take the monies from non-defense programs —   mandatory or discretionary — or increase the federal deficit, which is very unlikely.

Thus, we are likely into a “guns vs. butter” fight this year, with strong policymaker sentiment in both directions and most members of Congress yearning for a way to avoid choosing. Congress thought it settled this question through FY 2023 when it passed the Budget Control Act of 2011, creating a decade’s worth of budget caps specific to defense and non-defense spending. While the Alliance will not be taking sides in this larger battle, the downward pressure on all non-defense programs will be enormous. There is no question that FDA is at risk.

What the President must decide — in his budget outline before mid-March and then reinforce or modify in the full budget request by late April-May — is into which of three buckets to assign every non-defense federal program. The first bucket will contain programs slated for larger cuts based on policy or ideology. The Environmental Protection Agency (EPA) is clearly going to be in this bucket, as will foreign aid programs and support for the arts and humanities.

The second bucket will contain programs slated for an average cut — think 10 percent to 15 percent, probably across-the-board — in order to generate the monies necessary to pay for defense and for which the Administration sees no justification for giving special treatment. The bulk of federal programs will be in this second bucket.

The third bucket will be a select group of programs for which the Administration will be advocating for a smaller cut, level funding or possibly an increase. I anticipate this bucket will include the FBI, border security, veteran’s programs and maybe air traffic controllers.

Relative to the Trump Administration, the Alliance’s primary goal will be to advocate and show the justification for FDA being placed in the third bucket. This would not only benefit us in having a higher baseline in the president’s request, but would also send a strong message to Congress that FDA is a priority, whose portfolio of activities represent core functions of government.

Getting into the third bucket is going to be a tough sell with a new Administration that hasn’t yet figured out what it thinks about FDA. Further, the process makes such advocacy almost impossible.

The initial budget guidances were sent by OMB to departments only the first week of March. It is unclear whether HHS is following the traditional pattern of sending allocations to agencies and entertaining appeals. Even if so, there will not be a lot of time for back-and-forth discussions with agencies, given the apparent time constraints. FDA’s fate in the Trump budget will truly be in HHS’s hands. While Congress will have the final say, it would be invaluable if the Administration would lead the way in recognizing FDA “exceptionalism.”

Regardless where Congress ultimately nets out on defense increases vs. non-defense cuts, the environment for funding increases for non-defense programs is going to be difficult. We need to be steadfast in our message that individualized, policy-driven consideration of agency missions and responsibilities should be the key to appropriations process, rather than across-the-board decisions.

We hope the current process, Congress and the Executive Branch, will allow for this. If that happens, we believe that FDA is a unique agency with unique responsibilities and can justify its current funding level or even the small increase that the Alliance is requesting.

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1. We should all be grateful for the protection that FDA provides us against unsafe food, drugs, devices, and other products. Serious problems still exist and FDA works diligently to set standards and perform the inspections that minimize consequences. More broadly, it is instructive to read FDA’s long history and realize that, without FDA, we would be faced with multiple unsafe products every day. That was the reality when FDA came into being more than a century ago.
2. We should all be grateful for the medical products FDA reviews and approves that lessen the personal and societal burden of illness and disability. Medical products are a beneficial and broadly available part of our lives. Yet we take it for granted. When Medicare was created in 1965, there was no “drug benefit” in large part because medications were a negligible part of medical care. It has also been said that in the first half of the 20th Century, most medical visits did not produce any positive outcome — patients were no better or worse than if they had stayed home and not sought professional medical help. All of this has changed, with FDA the common element in the medical products that have changed how long we live and how well we are each day.
3. We should all be grateful for FDA’s commitment to flexibility and innovation. There have always been critics of FDA who have accused the agency of inflexibility and resistance to change. And, perhaps, some of the time they may have been right. But that is no longer the way the agency conducts business or thinks of its commitment to the American people. Recently, some of the tussles over FSMA have demonstrated FDA’s willingness to reconsider what it has proposed. So, too, programs such as breakthrough drugs reflect the agency’s ability to reassess its processes and adopt new ones to meet emerging needs.
4. We should all be grateful for FDA’s culture that recognizes that the job is never done — whether the focus is food safety, medical product safety, or approval of medical products. FDA staff are incredibly hard-working. People work long hours to get their jobs done. By itself, that is reason to be grateful. However, it extends beyond that to a culture that realizes that safe foods and safe and effective medical products are dynamic challenges. The value of the agency’s work is not diminished just because it can never be completed. Individuals get days off, but FDA never does.
5. Finally, we should all be grateful for FDA’s adherence to the “rule of law” — the legal principle that law should govern a nation, as opposed to arbitrary decisions by individual government officials. Not everyone is going to agree with every FDA decision. As a result, stakeholders meet with the agency to express their views, send letters, respond to draft regulations and guidances, submit citizen’s petitions, testify at advisory committees and so on, including occasionally suing the agency. Such differences of opinion are to be expected given the importance and complexity of the issues with which FDA must deal every day. Yet, within those many expressions of position and disagreement, you rarely hear FDA accused of either favoritism or vendetta. The rule of law is very much a part of the agency’s approach to its responsibilities.

What about FDA are you grateful for? We would welcome hearing from you. If there are particularly interesting ones, we will discuss them further in columns in December.