Compounding the problem

The FDA staff says compounding pharmacies shouldn't be allowed to produce untested peptides. RFK Jr.'s stacked FDA advisory committee thinks otherwise.

In years past, journalists covering any Food and Drug Administration advisory committee meeting would invariably add this boilerplate sentence to their stories: “The FDA almost always follows the advice of its advisory committees.”

That axiom will be put to the test after the agency’s Pharmacy Compounding Advisory Committee yesterday approved four untested peptides for manufacturing and sale. The 12-member committee, half of whom will financially benefit from the recommendation, will consider another three today.

None meet the FDA’s standards for safety and efficacy. Indeed, according to the FDA’s professional staff who reviewed the medical evidence behind the drugs, none have even been tested for either of the two requirements that have been the twin touchstones for agency drug approvals since 1962.

The committee contains eight new members handpicked by Robert F. Kennedy Jr.’s Health and Human Services Department. None have been vetted for conflicts of interest by FDA staff, who traditionally perform that task. Six of the eight have crude conflicts in that they run wellness, longevity and regenerative medicine clinics that prescribe peptides.

The roster also includes Robert Harshbarger, a Republican state senator from Tennessee. His mother, Rep. Diana Harshbarger (R-TN), is a pharmacist who last year introduced legislation that would, among other things, “remov(e) outdated labeling restrictions” on manufacturing facilities that mass produce peptides.

An entire industry has grown up around the manufacture and sale of peptides, small protein building blocks that allegedly perform miracles like wound healing, muscle building and promote longer life. They’ve become mainstay treatments at medical clinics and spas across the country where people with money to burn (no insurance will cover them) go for treatment, and are easily available through telehealth firms where medical professionals (perhaps licensed, perhaps not, who knows?) “prescribe” them for “patients” they’ve never seen, who self-describe their symptoms over the phone or online.

Peptides are being promoted by online influencers like Joe Rogan. They have a champion sitting atop the Health & Human Services Department. And they have received kind words from the paragon of ill-health (physical as well as mental) sitting in the White House. For more background on peptides, see this article on GoozNews published three months ago.

Today, let me address one simple fact. The FDA is not required to follow the advice of this illegally constituted advisory committee.

Why illegally constituted? The Federal Advisory Committee Act (FACA), signed into law by President Richard Nixon in 1972, prohibits any scientist, official, consumer or patient representative from sitting on a federal advisory committee if they have a financial stake in the outcome of its deliberations.

The sole exception is if their expertise is crucial to carrying out the committee’s charge and cannot be obtained elsewhere. In that case, the agency constituting the committee may issue a waiver outlining why their expertise is necessary. The agency issuing those waivers must post them on the government website that lists the committee rosters (there are hundreds across the federal government).

Where are the waivers?

The General Services Administration website that hosts the searchable FACA database is currently non-operational. In 2018, the first Trump administration outsourced management of the database to Salesforce, the software giant based in San Francisco that manages sales for corporations. Instead of maintaining a searchable database, Salesforce began posting Excel files with the data. The company has not updated the files on the GSA website since 2024, that is, since the start of the second Trump administration.

Some enterprising journalist might consider making a Freedom of Information Act request to GSA and HHS for a copy of the waivers issued when this new committee was created.

Yesterday’s recommendations, and three more certain to follow today, will present a major challenge for acting FDA commissioner Kyle Diamantas. Prior to Trump’s appointment to run the food division at the agency in 2025, the 38-year-old lawyer worked at the legal giant Jones Day representing food, beverage and tobacco industry clients. It is highly unusual for a non-physician or scientist to run one of its key divisions, much less the entire FDA.

Yet, when Diamantas was chosen in May to replace Marty Makary, he received high praise in the trade press that covers the FDA for his one-year tenure at the food division, whose staff had been decimated by DOGE. Its previous director issued an angry resignation letter after the mass layoffs.

Here’s what Stat reporter Lizzy Lawrence had to say:

Leaders in the food industry, public health groups, and FDA career staffers have found that Diamantas exceeded expectations. As Diamantas takes the reins at the FDA, STAT spoke with more than 10 of these stakeholders, as well as former FDA commissioners and Diamantas’ former colleagues. They all described him as thoughtful and serious, someone who does his homework before meetings and listens to the experts in the room. Crucially, Diamantas has earned the trust of key career staff.

The career staff did its best yesterday to lay the facts before the stacked committee. The seven peptides under consideration for being legalized for production by compounding pharmacies have never been tested for medical efficacy in human beings. Virtually all of the safety testing has been done in animals, not humans.

In other words, the physicians or other medical personnel offering these alleged medications are not engaged in the off-label prescribing, which is allowed. There are no labels.

The long briefing monographs prepared for the committee for each of the seven peptides couldn’t have been more clear. The summary statements near the top stated in each case:

We have evaluated publicly available data on the physicochemical characteristics, historical use, safety, and effectiveness in compounding of these substances. For the reasons discussed below, we believe the evaluation criteria weigh against placing (name of peptide) on the list of bulk drug substances that can be used to compound drug products.

Attorney Diamantas. The ball’s in your court.