All Of Us Need To Be Rooting For The FDA

By Steven Grossman, FDA Matters

There is very little support among stakeholders and FDA employees for the 2025 version of the FDA.[1] Some of us are discouraged. Some of us are trying hard to find the good in agency proposals and actions.

Regardless of where any of us stand, all of us need to be rooting for the FDA to be successful.

Commissioner Makary is operating in a political environment that is arguably more challenging than any FDA commissioner has faced since the agency’s creation in 1906.

Some of the obstacles that Commissioner Makary faces include:

• An administration that prefers the “rule of men” and does not respect the “rule of law.”
• An administration that does not acknowledge the importance of expertise, notably but not exclusively scientific expertise.
• An administration that wants to thwart China’s ambition for global leadership yet is unable or unwilling to see that slashing NIH’s budget by 40%[2] and cutting upwards of 20% of FDA staff is a wholly inappropriate response to that challenge.
• An administration that claims it has a commitment to children’s health, food safety, and nutrition, but relies on experts handpicked for their biases and supports cuts to feeding programs and Medicaid without acknowledging any connection between those actions and their stated goals.[3]
• An administration that claims to want to combat chronic disease but has been strangely silent about the most easily implemented action: further reduction in tobacco consumption.
• An administration that thinks the FDA is a sock-puppet for industry.

Heavy, indeed, is the head that wears the FDA crown.

I appreciate the enthusiasm, intellect, and articulateness that Commissioner Makary brings to the job. I support (up to a point) his plans for shortening review times. I agree with FDA working cooperatively with patients and industry. I hope he has surrounded himself with people who will tell him “no” when the situation warrants a “no.” I really like his commitment to the adoption of AI. The rehirings have been a plus, as well as his sensible decision to support user fees negotiations.[4]

Of course, my “being discouraged” and “looking for the good in agency proposals and actions” reflects the many things that I would wish for him to do differently or better. For example, I urged the agency to be more incremental in its roll-out of AI.[5] I am confused by his use of “gold standard science” and “radical transparency.”[6] I am skeptical of his glossy optimism about FDA’s post-RIF capabilities. I would like Makary to figure out what the FDA cannot do or cannot complete in a specific timeframe…and publicly address statutory, Congressional, and stakeholder concerns.[7] I worry about the decline of outside consultation through advisory committees, and it scares me that the specter of political interference is ever-present.[8]

Why root for FDA and for Commissioner Makary to be successful?

• Because a stable and functional FDA, regardless of its flaws, will be better for the American public and stakeholders than a chaotic and dysfunctional agency.
• Because our nation’s public health and commerce are threatened when $3 trillion of goods and services lack meaningful oversight. None of us benefit from a return to “caveat emptor” in the food and drug marketplaces.
• Because the CDC vaccine debacle, borne at least somewhat from a vacuum of leadership, shows how important it is to have an FDA commissioner who 1) will defend good science and 2) resist the triumph of random (and often untrue) anecdotes. Hopefully, Commissioner Makary will commit to defending science in the face of such threats.[9] He certainly understands the bedrock of good science: findings based on statistics, well-controlled trials, and reproducible results.
• Because the next two to three appropriations cycles and the negotiation of the next user fee agreements will be on Commissioner Makary’s watch. An underfunded regulatory agency will say “no” far more often because it does not have the time, resources, or focus to reach a nuanced “yes.”

Nobody gets a free pass, as FDA Matters columns[10] will continue to demonstrate. I may be optimistically projecting more than Dr. Makary can or wants to deliver.

Nonetheless, it is a complex world where the path to a stronger and more effective FDA often contains twists and turns....and the perfect is often the enemy of the good.

We need continued dialogue among all stakeholders and the FDA that reflects that the betterment of FDA is a universal goal.

References:

[1] https://www.linkedin.com/pulse/inside-changing-fda-winners-losers-uncertainty-steve-usdin-15jbe/?trackingId=0rXpBMQ9l6kQ8R3M9Hbkkg%3D%3D

[2] https://www.fdamatters.com/fdamatters/elon-musk-and-the-future-of-government-investment-in-our-nations-future

[3] For example, in 2023, 41.5% of mothers had Medicaid at the time of birth. https://www.marchofdimes.org/peristats/data?reg=99&top=11&stop=154&slev=1&obj=18

[4] https://www.fdamatters.com/fdamatters/finally-some-encouraging-news-from-fda

[5] https://www.fdamatters.com/fdamatters/the-skeptical-enthusiasts-guide-to-ai-at-fda

[6] https://www.fdamatters.com/fdamatters/alice-humpty-dumpty-and-the-new-administration

[7] https://www.fdamatters.com/fdamatters/truth-telling-fda-user-fee-edition

[8] https://www.fdamatters.com/fdamatters/fda-and-politics-an-unhealthy-combination

[9] https://www.nytimes.com/2025/06/05/health/kennedy-stem-cells-experimental-treatments.html

[10] www.fdamatters.com. Readers can subscribe on the website or send a note to sgrossman@fdamatters.com to ask to be added to the subscription list.

A version of this article was previously published on the ERA Sciences website. Republished with permission.

About The Author:

Steven A. Grossman, JD, is president of HPS Group, LLC and a policy and regulatory consultant and former government official. In recognition of his advocacy and policy leadership, he was awarded the Reagan-Udall Foundation for the FDA’s Innovations in Regulatory Science Award in December 2024. As president of HPS Group, he has served nine years on the National Organization for Rare Disorders board and continues as a member of the group's Advocacy Committee. He also created the FDA Matters website in 2009 and authored over one hundred blog columns over four years. Notably, these columns include a contemporaneous account of the Congressional passage of the Biologics Price Competition and Innovation Act (BPCIA).