Weedy Concerns Amidst a Flood of FDA Issues
Flooding the zone has proven to be an extremely effective strategy for the Trump administration. Every day, there are dramatic headlines that I need to ignore to stay focused on the topic that matters most to me, namely the FDA. The flood has been unrelenting.
The FDA is at a crossroads — with numerous initiatives, several threats, and constant tension between its statutory responsibilities and a White House and HHS leadership that views science as highly manipulable for their own ends.
Our nation’s health, well-being, and economy depend on a successful FDA (All of Us Need to be Rooting for FDA). However, that does not give the Commissioner carte blanche to define success solely by his own vision....nor does it absolve the stakeholder community from a responsibility to speak out constructively about the state of the agency and how it could better perform its duties.
As an advocate for a more effective, efficient, and fair FDA, I have compiled a roundup of some of the most concerning FDA issues as of September 26, 2025.
Who’s Really In Charge? For the most part, FDA’s statutory responsibilities are assigned by law to the Secretary of Health and Human Services. In turn, the Secretary has delegated those FDA responsibilities to the Commissioner. In many instances, the Commissioner has re-delegated certain responsibilities to subordinate FDA officials.
Delegated authority can be withdrawn, in whole or in part, at any time. Or the commissioner can be replaced if he doesn’t heed the Secretary’s wishes. Either way, this can influence the Commissioner’s approach to decision-making.
The risk of the “CDC-ification” of FDA is real, regardless of how high or low you assess the probability of it occurring. I discussed some of the ramifications in prior columns: FDA and Politics: An Unhealthy Combination and If You Are Not Confused, Then You Are Not Paying Attention.
Reputational Integrity. The FDA has a positive global track record based on the agency’s expertise and credibility. Agency downsizing has diminished expertise. A lack of clarity and consistency in decisions has undercut the agency's credibility.
Downward pressure on the agency’s reputation has been compounded by several factors, including the Secretary’s opposition to vaccines, the agency’s frequent absence from international meetings, the inconsistent direction of MAHA, and the continued mixed signals regarding approval standards for treatments for ultra-rare orphan diseases.[1]
Mission-Creep. Dr. Makary announced “The Commissioner’s National Priority Voucher (CNPV) pilot program (FDA description) in June 2025. It injects a bit of ARPA-H spirit (“go big or go home”) into the process of incentivizing companies to invest in larger, riskier, and more transformative drugs and biologics. That’s intriguing.
Under the new program, accelerated review and a voucher can be granted based on non-medical national priorities, notably a company’s commitment to onshoring drug manufacturing or increased affordability.
Onshoring should stay in its own lane (programs to promote advanced manufacturing), and FDA should never be basing its approval process or decision on pricing. Leave the cost of medications to the Centers for Medicare and Medicaid Services (CMS) and other relevant agencies; keep it separate from product approvals.
Growing Disinterest in Public Input Into Agency Decisions. In the past, the FDA has committed to seeking public input before making certain decisions. Examples include comment periods on rulemaking, advisory committees with open public testimony, FDA participation at annual meetings and conferences, and frequent meetings with stakeholders. This has all but disappeared.
While there have been some efforts to make FDA activities more public and transparent after the fact (release of current CRLs; new release of information on food recalls), that is different from encouraging public input before making decisions.
Potential Explosive Growth in Adulterated and Counterfeit Products Regulated by FDA. Very few Americans appreciate the challenge FDA faces in ensuring that Americans have a safe supply of food and medical products. I mentioned the 2008 Chinese milk scandal in an earlier column (here). The feedback made clear that even FDA-watchers do not understand how profitable it can be to cut corners and/or evade FDA regulation.
SNAP and Medicaid cuts, tariffs, economic disparities, the weakening of disease surveillance programs at the CDC and elsewhere, a smaller FDA staff, and many other factors are likely, within the next two to five years, to exacerbate the crisis of adulterated and counterfeit products.
FDA in the Center of Hot Controversies That Divide Our Society. MAHA’s goal of remaking the American diet and the just-announced safety review of the abortifacient, mifepristone, are in no way similar as issues, but they share in common that they are going to put FDA in the crosshairs of broad and passionate societal divisions. FDA is not a better or more efficient agency if Commissioner Makary is preoccupied with dealing with controversial issues that are only a small part of the agency’s responsibilities.
[1] It is tempting to measure the threat to FDA’s reputational integrity by the Annenberg Public Policy Center survey released a week ago, which showed decreased levels of confidence in FDA and the other public health agencies. However, the shift is attributable to changed attitudes among Democrats (no surprise) and does not show a more generalizable change in public opinion.
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