Why Influencers Use the FDA to Bash Research Peptides

The FDA's drug review process is funded, in large part, by the companies whose drugs it approves.

This is not a conspiracy theory. It is written into federal law through something called PDUFA, the Prescription Drug User Fee Act, which is the legislation that requires pharmaceutical companies to pay fees directly to the FDA in exchange for having their applications reviewed. The fee for a single drug application in fiscal year 2024 is $4,198,000. And those fees, collected from the industry being regulated, make up approximately 65% of the FDA's entire human drug review budget.

That means the agency evaluating whether a drug is safe for you to take is financially dependent on the companies submitting the drugs.

Now, that alone does not mean every approval is corrupt or that every drug the FDA clears is dangerous. The fees were introduced in 1992 specifically to speed up review timelines, which genuinely helped get treatments to patients faster, and the science behind most approved drugs is real. But the structure of the funding creates something worth understanding, because it shapes what gets reviewed in the first place, and more importantly, what never does.

To understand why, you have to follow the economics of drug development all the way back to the beginning.

Getting a drug through FDA approval costs a median of $985 million in capitalized research and development investment, according to data published in JAMA Internal Medicine covering approvals from 2009 to 2018. That number accounts for the cost of the trials that fail along the way, not just the ones that succeed. No company spends close to a billion dollars on that process unless they can recover it, which means you need a patent. A patent gives a company the exclusive right to sell that drug for roughly twenty years, and during that window they charge what the market will bear and recoup the development cost with margin on top.

This is why peptides, as a category, are largely absent from the FDA approval pipeline. Many of the peptide sequences researchers study are naturally occurring in the human body, which means they cannot be patented. There is no twenty year exclusivity window to protect a billion dollar investment. So no pharmaceutical company will spend the money to run the trials, pay the application fees, and push a naturally occurring sequence through the full approval process, because the financial architecture that makes drug development rational as a business does not apply.

The result is not that the peptides are unsafe. The result is that no one has paid to prove they are safe through the formal channel, because that channel was designed around a profit motive that does not exist for these compounds.

The relationship between the FDA and the companies it regulates does not stop at the fee structure. A study published in Science looked at FDA medical officers who left the agency between 2006 and 2019 and found that 62% of them went directly to work for the pharmaceutical industry. Scott Gottlieb served as FDA Commissioner from 2017 to 2019 and joined Pfizer's board of directors the same year he left. The pharmaceutical and health products industry spent $374 million on federal lobbying in 2023 alone, which made it the single highest spending industry that year, with roughly three registered lobbyists for every one member of Congress.

This is not a fringe critique of the system. These are public records.

So when someone points at the FDA approval stamp as the primary measure of a compound's safety, they are pointing at a system where the companies being regulated fund the regulation, where the regulators frequently end up employed by the companies they regulated, and where the lobbying spend ensures that the legislative framework governing all of it stays favorable to the same industry.

That is the system being used as the authority.

Now here is where it becomes relevant to something specific. Compounded peptides, meaning peptides prepared by a licensed compounding pharmacy, exist inside a different FDA framework than research chemicals do. Compounding pharmacies operate under state board oversight and certain FDA guidelines, which gives the compounds they produce a layer of institutional legitimacy that research chemicals technically lack. And some people in the health and performance space have built businesses around selling access to compounded peptides while simultaneously using the FDA's authority to argue against research chemicals.

The argument is: research chemicals are unregulated and therefore unsafe, so you should use the compounded version instead, which I sell.

But if the FDA's authority itself is structurally compromised by pharmaceutical funding, revolving door employment, and lobbying at the scale described above, then using that authority as your safety argument while also positioning yourself against regulatory overreach everywhere else is not a coherent position. You are selecting the parts of the system that support your business and discarding the parts that do not.

The honest framing of research peptides is not that they are FDA approved and therefore safe, or that they are unapproved and therefore dangerous. The honest framing is that the approval pipeline was built to serve a patent based pharmaceutical economy, and compounds that do not fit that economy will not move through it regardless of their actual risk or benefit profile. The absence of FDA approval tells you something about the economics of the approval process. It tells you very little about the compound itself.

Understanding what the FDA actually is, a partially industry funded agency with a substantial revolving door and a legislative environment shaped by nine figure lobbying spend, does not mean you should take everything unapproved without thinking. It means the approval status of a compound is a data point about pharmaceutical economics, not a verdict on safety.

Those are different things. And treating them as the same thing, especially while profiting from the distinction, is where the argument breaks down completely.

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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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