FDA Just Killed the American Peptide Market
Another love letter to Big Pharma, green-lit by the White House
FDA has just tipped its hand on peptides, and the hand is a losing one for the hundreds of thousands of Americans who depend on naturally-occurring, non-patentable peptides to relieve pain, heal injury, speed recovery, and generally improve health.
The agency just released a briefing memo laying out its intention NOT to allow peptides to be authorized for sale by pharmacy compounders.
Despite the fact that there’s a critical meeting of the FDA’s Pharmacy Compounding Advisory Committee (PCAC) on July 23-24, and despite the fact that relevant evidence for that meeting isn’t due to be submitted by either proponents or opponents of peptides until July 9th, the FDA has pre-determined its decision.
Now, to be clear, FDA is not bound to take the advice of the committee.
Even if every health-optimized peptide enthusiast bikes, swims, or sprints to the meeting from across the country and storms the meeting in barefoot shoes and organic boxer shorts.
But it’s pretty defiant that the FDA didn’t even pretend to consider public input on the question before telling the world that they fully intend to deny Americans access to these peptides.
Sadly, it’s unusual for the agency to change its mind once they’ve committed pen to paper like this.
Even though they’re about to receive the data from three US-based randomized controlled trials showing flawless safety data on American study subjects. Even though the president’s pet pollster has made it abundantly clear that approving peptides polls at above 60% among Republicans, Democrats and Independents, especially among middle-aged women - a critically needed demographic.
Even though ground zero for peptide use and manufacture is in Texas, where Republican Senate candidate is in the race of his life and could use the help.
Nonetheless, I’m told by multiple sources that White House staffer Heidi Overton MD, a health advisor on the Domestic Policy Council, gave the green light to FDA on this position. Public release of the agency position - pushed by Pharma-friendly deep staters at the FDA - came as a shock to the (slightly) more MAHA-sensitive FDA political leadership.
This seems like yet another gift to Big Pharma, who doesn’t want competition from compounding pharmacies creating useful products, based on natural substances, and selling them directly to consumers outside the insurance system.
Perhaps one explanation is that PhRMA - the industry’s powerhouse lobbying group - is apparently on the hunt for a new top lobbyist. Rumors are swirling that half the brain trust of the top health officials in the administration have applied for the $8 million a year job. Interviews start next week. Guess we’ll all have to sweat out the MAHA betrayals until the horse race is over. Sigh.
If you’d like to submit a comment to politely but firmly share your thoughts with FDA on this action, click the blue comment button at the docket page here. The deadline is July 22nd.