Why Influencers Use the FDA to Bash Research Peptides

The FDA's drug review budget does not come from taxpayers. It comes from the pharmaceutical companies whose drugs are being reviewed, and that single fact explains more about modern medicine than almost anything else you will learn.

The mechanism is something called PDUFA, the Prescription Drug User Fee Act, which is the law that requires pharmaceutical companies to pay fees to the FDA every time they submit a drug for approval. The FY2024 application fee sits at $4,198,000 per submission, and when you add up all the fees across all the companies, those payments now fund roughly 65% of the FDA's entire human drug review budget. The agency reviewing the drugs is majority-funded by the industry it is supposed to regulate. That is not a conspiracy theory. That is the published budget.

Now think about what that does to the incentive structure.

When a regulator depends on an industry for the majority of its operating budget, the relationship between regulator and regulated starts to look less like a watchdog and more like a business partnership, and the data on what happens when FDA officials leave the agency makes that relationship explicit. A 2018 analysis published in Science found that 62% of FDA medical officers who left the agency between 2006 and 2019 went directly to work for pharmaceutical companies. Scott Gottlieb served as FDA Commissioner from 2017 to 2019 and joined Pfizer's board of directors the same year he left. The people setting the rules go on to profit from the companies that followed them.

And then there is the lobbying layer on top of all of that.

The pharmaceutical and health products industry spent $374 million on federal lobbying in 2023, which made it the single highest-spending industry in the country, with roughly 1,500 to 1,800 registered lobbyists working at any given time, which comes out to approximately three lobbyists for every single member of Congress. That is not an industry trying to survive regulation. That is an industry that has made itself structurally inseparable from the government that is supposed to oversee it.

This is the system that some influencers point to when they tell you that research peptides are unsafe because they are not FDA approved.

The argument sounds logical on the surface. No FDA approval means no safety data, means you should not use it, means you should use the compounded version from a licensed pharmacy instead, which is, conveniently, the product they happen to be selling. The FDA approval badge gets used as a signal of legitimacy, and for a lot of people that signal works because they do not know how the approval process is financed.

But here is where the argument collapses completely, and it has nothing to do with safety data.

Many of the peptide sequences that show up in research chemicals are naturally occurring. They already exist in the human body or were discovered in nature before any company had the chance to claim ownership of them, and that creates a problem that has nothing to do with science. A naturally occurring sequence cannot be patented. And if you cannot patent the molecule, you cannot protect your investment in getting it approved. Drug development through the FDA process costs a median of $985 million per compound according to a 2020 analysis in JAMA Internal Medicine, and no pharmaceutical company will spend nearly a billion dollars to run a drug through that system if any competitor can immediately produce the same molecule the day after approval with no legal consequences. The business model does not work.

So the peptides do not get submitted for approval not because the science is absent, not because there is evidence of harm, but because there is no profitable reason for any company to pay $4 million in fees plus $985 million in development costs to approve something they cannot own on the other side of that process.

The FDA approval system, under its current funding structure, is not designed to evaluate whether something is safe and effective in the abstract. It is designed to evaluate whether something is safe and effective enough to justify the investment of a company that expects to recoup that investment through exclusivity. Molecules that fall outside that structure do not get evaluated. They get ignored, and then that absence of evaluation gets repackaged as a safety concern.

That repackaging is what makes a certain type of influencer possible.

The logic works like this: use the FDA's authority as a shorthand for legitimacy, criticize research chemicals for lacking that legitimacy, and then sell a compounded alternative that technically operates under pharmacy regulation rather than FDA drug approval, which is its own set of nuances, while presenting yourself as the responsible option. You are borrowing the credibility of the institution in one breath and selling around it in the next.

You cannot use a corrupt system as your authority when it supports your business model and then position yourself as an outsider fighting against that same system when it does not. That is not a philosophical inconsistency. That is a sales strategy dressed up as principle.

The deeper issue is what gets left behind when this is the system we have. There is a category of compounds that may genuinely be worth understanding, that exist in a gray zone not because they failed some rigorous evaluation but because they were never submitted to one, because the economics of submission made no sense for any company with shareholders to answer to. The research on those compounds lives in academic literature, in animal studies, in small human trials, and in the lived experience of people using them, none of which counts as FDA approval and all of which is more meaningful than the absence of a fee payment.

The approval stamp does not mean safe. The absence of the approval stamp does not mean dangerous. It means no company calculated that the profit math worked out.

That is the whole point.

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References

1. FDA PDUFA Fee Schedule — Federal Register (published annually). FY 2024 application fee: $4,198,000.
2. FDA Budget Justification to Congress — PDUFA user fees fund approximately 65% of CDER/CBER human drug review budget.
3. Piller, C. (2018). "Is FDA's revolving door open too wide?" Science. Found 62% of FDA medical officers who left between 2006-2019 went to work for pharmaceutical industry.
4. OpenSecrets.org — Center for Responsive Politics. Pharmaceutical/health products industry spent $374 million on federal lobbying in 2023, #1 ranked industry. Approximately 1,500-1,800 registered lobbyists (roughly 3:1 ratio to members of Congress).
5. Scott Gottlieb served as FDA Commissioner 2017-2019, joined Pfizer board of directors in 2019.
6. Wouters, O.J., McKee, M., Luyten, J. (2020). "Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018." JAMA Internal Medicine. Median capitalized cost: $985 million per drug.

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