The Appointment That Changed My View of the FDA
A few years ago I was sitting in a dermatologist's office in Nashville, waiting for a routine follow-up on a spot that had turned out to be nothing. My doctor — a sharp, no-nonsense woman who has been in private practice for twenty-two years — was reviewing my chart and mentioned, almost offhandedly, that the topical she'd been prescribing me had just been reformulated by the manufacturer.
The reformulation wasn't for safety reasons. It wasn't because the original formula was ineffective. It was because the manufacturer had received a new patent on the reformulated version, which reset the exclusivity clock and allowed them to charge $340 for what had previously cost $28 as a generic. Same active ingredient. Different inactive ingredient mix. New patent. My doctor said, clearly frustrated, "There's a perfectly good generic version that works just as well, but I can't prescribe it without a prior authorization fight with your insurer, and most patients just give up and pay for the branded version."
She didn't mean it as a political statement. She was just describing her day. But that sentence contained more information about what's wrong with American healthcare regulation than anything I've read in a policy paper.
The FDA approved the reformulation. The patent office issued the new patent. The insurance system responded by making the cheaper alternative difficult to access. My doctor — the person with twenty-two years of expertise in what actually works on human skin — was forced to fight a bureaucratic process every time she tried to prescribe the version she believed was clinically equivalent. That's not a market. That's a regulatory capture machine.
Regulatory Capture Isn't a Theory — It's My Dermatology Bill
Regulatory capture is a concept that gets thrown around in libertarian policy circles and then ignored by everyone else as too abstract to generate political energy. Let me make it concrete. Regulatory capture is when a drug company's legal team has more influence over what gets prescribed in that exam room than the doctor who went to medical school, completed a residency, and has treated thousands of patients.
The pharmaceutical industry spent $373 million on federal lobbying in 2023 alone. That figure, from the Center for Responsive Politics, doesn't include state-level lobbying, campaign contributions through PACs, or the revolving door between FDA regulatory positions and pharmaceutical company advisory roles. The same people who approve drugs go on to work for the companies whose drugs they approved. This is documented. It is legal. And it produces exactly the outcome you'd expect: a regulatory system that is extraordinarily good at protecting incumbent pharmaceutical revenue streams and quite mediocre at actually optimizing patient outcomes.
My dermatologist doesn't lobby. She sees thirty-five patients a day, does her own billing because she can't afford a full billing staff, and spends roughly two hours of every working day on administrative tasks — prior authorizations, insurance appeals, documentation requirements — that have nothing to do with medicine. She graduated from Vanderbilt. She did everything right. And the system treats her as an obstacle to manage rather than an expert to consult.
What Deregulation Actually Looks Like — And Why the Opposition Is Wrong
The standard critique of deregulation in healthcare goes like this: if you loosen FDA oversight, unsafe drugs enter the market, people get hurt, the vulnerable bear the brunt. This critique is deployed reflexively against any proposal to streamline approval processes, allow more generics, or reduce the administrative burden on independent practitioners.
The critique proves too much. The current system, with its full complement of regulations, produces outcomes that are demonstrably bad for patients in specific, measurable ways. Drug approval timelines in the United States average 12 years and $2.6 billion per approved compound. That timeline kills people who die waiting for treatments that have already proven effective in Phase II trials. The cost figure drives drug pricing to levels that make treatment inaccessible for uninsured and underinsured patients. These are regulatory harms. They don't get counted the way adverse event reports get counted, but they are real and they are large.
What my dermatologist wanted was simple: the freedom to prescribe what she knew worked, without fighting an insurance company that was operating under incentives created by a regulatory structure that made the inferior branded version the path of least resistance. That's a small ask. It requires no new drug approvals, no safety compromises, no radical restructuring. It requires that the system treat physician judgment as a legitimate input rather than a liability to be managed.
The libertarian position on healthcare regulation isn't "no rules." It's "the rules should serve patients, not incumbent industries." Those are different things. And the conflation of the two — which happens constantly in media coverage of healthcare policy — lets a deeply dysfunctional status quo coast on the implied endorsement of "safety" when what it's actually protecting is revenue.
The Doctor in the Room
When I left that appointment, I spent the next week reading about pharmaceutical patent strategy. Evergreening. Product hopping. Authorized generics. The vocabulary of an industry that has become extraordinarily adept at using regulatory processes as competitive moats rather than consumer protections. None of it was secret. All of it was legal. And all of it was downstream of a regulatory structure that the people being regulated had significant input in designing.
My dermatologist retired her private practice last year. Sold to a private equity-backed dermatology group. Said she couldn't keep up with the administrative overhead as a solo practitioner. Twenty-two years of expertise, direct patient relationships, clinical judgment developed over tens of thousands of appointments — absorbed into a corporate structure that will see her patients for seven minutes and optimize for throughput.
That's what the regulatory system produced. Not safer skin care. The quiet elimination of independent practitioners who might otherwise push back on the system that's capturing them.
I want healthcare that works like my dermatologist worked — direct, expert, accountable to the patient in the room. What we have instead is healthcare designed by the people who profit most from its dysfunction. And fixing that requires being honest about what the regulation is actually doing, regardless of what it claims to be doing.
