Biology vs. Bullsh*t at the FDA

Guest post by Rep. Jake Auchincloss (D-MA-04)

Editorial credit: lev radin / Shutterstock.com

“In the long contest between biology and bullshit, biology is undefeated,” Auchincloss [told Bloomberg]. “The [FDA] commissioner is trying to wage that battle, and it’s going to be patients who lose.”

The Food & Drug Administration (FDA) is staffed by scientists who review evidence to determine the safety and efficacy of medicines. It’s a bureaucracy wrestling with biology, so of course it’s messy. But in general, they have done well. Away from the political spotlight, the FDA sifted through randomized controlled trials and debated surrogate endpoints with investigators. It became the world’s gold standard biomedical regulator.

Until 2025. Then, the bullshit started. A crew of anti-vax zealots, bio-hackers, and wellness grifters descended on the Department of Health & Human Services. Now, measles is breaking out; AI slop is replacing scientific review; the scientist who ensures your eye drops don’t blind you was fired; and the wealthy receive tax breaks for buying bidets.

The GOP is too afraid of RFK. Jr to hold a hearing. Big Pharma is rushing to the White House to cut pricing deals, averting its eyes from the FDA en route. While industry caves and Republicans shrug, the FDA has hemorrhaged competence and credibility. A former commissioner — who served in a Republican Administration — told me the FDA had lost 20 years in the last one.

Last week, a political hack, Vinay Prasad, overruled the FDA’s top vaccine scientist to reject Moderna’s mRNA vaccine. Safety and efficacy lost out to fear and favor. The FDA just reversed itself today, but the damage to public health and biomedical innovation from raw politics is profound. mRNA is the ‘software of life’, translating genetic code into the proteins that are the cell’s machinery. Engineering mRNA can defend against infectious disease, regenerate tissue, and even inoculate you against cancer. But this Administration refuses to research and regulate mRNA’s potential.

I represent a lot of scientists. I serve on the committee of jurisdiction for FDA issues. I’ve been on the warpath for the last year, but only in the last month has my pushback gotten traction. Democrats must sink our cleats into the foothold we’ve gotten and push off on a three-part FDA agenda of accountability, integrity, and innovation.

Accountability, first. Commissioner Marty Makary needs to be fired. Vinay Prasad needs to be fired. And any FDA official complicit in RFK Jr.’s anti-vax crusade needs to be fired. That starts with congressional oversight hearings, now. I’ve been working for months to build up pressure for them. If Democrats win the midterms, those hearings can become proper investigations.

Democrats must also restore the integrity of the FDA. The Commissioner’s National Priority Voucher program, which expedites drug reviews at the commissioner’s say-so, rewards companies with ties to MAGA over scientific breakthroughs. Every voucher handed out under this illegal program must be re-examined. It is a political end-run around scientists.

We must install new leadership that respects the firewall between the FDA and the White House, that recruits and empowers top-notch scientists to regulate industry, and that focuses on how to examine evidence on the safety and efficacy of medicine – without being distracted by wellness hashtags. (This includes issues fashionable on our side of the aisle, too. The non-GMO movement, for example, is divorced from any evidence about the safety or efficacy of genetically modified organisms.)

An FDA restored to accountability and integrity is a boon to innovators and a tax on snake-oil salesmen. Just as chemistry became an engineerable discipline in the 19th century, and physics in the 20th, biology can become an engineerable discipline in the 21st century. From food to fuel, materials to medicine, biotechnology will do wonders. But only if regulators follow the science, not RFK Jr.

Congressman Jake Auchincloss, a Marine veteran who served in Afghanistan, currently represents Massachusetts' 4th District and sits on the House Energy and Commerce Committee.