FOIAengine: Newly Remade Advisory Committee Green Lights Six Compounds, Despite the Applications Being Pulled
Bobby Harshbarger is a Tennessee state senator and pharmacist of noteworthy lineage, with an interesting backstory.
Both of his parents are pharmacists by training, and Bobby now runs Premier Pharmacy, the family’s multi-million-dollar compounding business based in Kingsport, Tenn. His mother, Rep. Diana Harshbarger (R-Tenn.), remains a licensed pharmacist and is affiliated with the business. His father, Robert Harshbarger, Jr., is a convicted felon whose Tennessee pharmacist’s license was revoked 13 years ago.
The elder Harshbarger was sentenced to 48 months in federal prison in 2013 after pleading guilty to a five-year scheme in which he defrauded health-care benefit programs by substituting a cheaper, unapproved Chinese drug for the FDA-approved drug that kidney dialysis patients were supposed to receive. He was released from prison on June 12, 2017.
President Trump pardoned Harshbarger, formerly known as federal inmate #22800-031, on November 7 of last year. The good news came on a Friday.
The following Monday, Diana Harshbarger sent a letter to Health and Human Services Secretary Robert F. Kennedy, Jr. Writing “as both a pharmacist and Member of Congress,” and citing “promising clinical evidence,” she asked Kennedy to ease restrictions on peptides as a matter of “pressing clinical necessity.”
Peptides are short chains of amino acids that act as signaling molecules in the body. GLP-1 drugs are the best-known examples, but other synthetic peptides have become the latest thing in the anti-aging, fitness and wellness worlds.
Although the FDA has identified a number of peptides as posing significant safety risks and restricted their use in compounding, Rep. Harshbarger wanted a reset. “Clinical and preclinical research supports the therapeutic potential of a number of peptides,” she wrote. She listed six that she believed deserved reconsideration.
Kennedy, an avowed peptide enthusiast, didn’t need much prodding. Before taking office, he pledged to end what he called the FDA’s “aggressive suppression” of peptides “I’m a big fan of peptides,” Kennedy told Joe Rogan, host of the enormously popular Joe Rogan Experience podcast, in February. “I’ve used them myself.” The segment has been viewed 1.8 million times. Kennedy told Rogan that FDA restrictions had helped drive the products into a gray market, where consumers had no assurance of what they were getting.
Things were about to change.
On April 15 of this year, the FDA announced that its Pharmacy Compounding Advisory Committee would meet to consider whether seven peptide groups that had been nominated years earlier (2018 and 2020) should be added to the agency’s list of bulk drug substances that may be used in traditional pharmacy compounding. The peptides would be added to what’s known, in FDA parlance, as the 503A Bulks List. Getting those peptides on the list would open a regulatory path for traditional compounding pharmacies to make them for individual patients.
The seven were:
- BPC-157, promoted for healing and recovery. The FDA evaluated it for ulcerative colitis.
- KPV, an anti-inflammatory peptide evaluated for wound healing and inflammatory conditions.
- TB-500, a fragment related to thymosin beta-4, evaluated for wound healing.
- MOTS-c, a mitochondrial-derived peptide promoted for metabolic health. The FDA evaluated it for obesity and osteoporosis.
- Emideltide, also known as delta sleep-inducing peptide or DSIP, evaluated for opioid withdrawal, chronic insomnia and narcolepsy.
- Semax, a synthetic peptide evaluated for cerebral ischemia, migraine and trigeminal neuralgia.
- Epitalon, a synthetic peptide widely promoted for longevity and anti-aging, which the FDA evaluated for insomnia.
Except, there was a wrinkle. The peptide nominations that the FDA committee would be considering had inexplicably been withdrawn – a day earlier – by their nominators, Wells Pharmacy Network and LDT Health Solutions, the latter acting on behalf of the International Peptide Society.
That didn’t slow things down. The FDA went ahead with plans for the meeting. Soon, a new charter for the FDA’s compounding advisory committee was filed. And not long after that, eight new members were added to the advisory committee. One of the new members was the aforementioned Bobby Harshbarger. Now, a majority of its standing members were newly appointed, and seven of the eight new members had ties to peptide-related businesses and clinics.
When the FDA’s remade advisory committee got down to business late last month during two marathon sessions at the agency’s suburban Maryland campus, the agenda was straightforward. The committee was to consider whether seven peptide groups – the very same seven whose nominations had been pulled from consideration by their proponents – should be recommended for inclusion on the 503A Bulks List.
Buried in hundreds of pages of preparatory materials for the advisory meeting was the FDA staff’s recommendation. Agency scientists opposed adding any of them to the list. The issues raised by the FDA scientists varied by peptide, but the pattern was consistent: scant or nonexistent human evidence, unresolved questions about safety and effectiveness and, in some cases, uncertainty about exactly what substance was being sold under a particular peptide name.
One thing the FDA handouts did not explain was why the agency was moving ahead on the withdrawn nominations.
Four hours into the discussion on Day One, before the voting began, Bobby Harshbarger posed that very question: “Give me that rationale of moving forward with these particular ingredients that have been withdrawn.”
The FDA’s answer was strikingly vague: The peptides had been “deemed to be a priority,” an agency official replied, citing “a number of factors” – including “the large interest here in considering these substances.”
Whose interest? And why was FDA pressing ahead with nominations their own proponents had just withdrawn? The official answering Harshbarger’s question didn’t say.
And the agency still hasn’t. The FDA didn’t respond to our questions.
During the meeting, however, Lee Rosebush, chairman of the American Academy of Peptide Medicine and an attorney who has represented compounding pharmacies in litigation challenging the FDA restrictions, dropped a potentially significant clue. Speaking during the public-comment portion of Day Two, Rosebush implied that the FDA itself had requested at least some of the withdrawals.
Rosebush did not explain who at FDA made the request, precisely which nominations he was referring to, or why the agency would ask for nominations to be withdrawn only to proceed with evaluating the substances anyway. FDA has not publicly confirmed his assertion.
What is clear is where FDA’s own scientists stood: They opposed adding every one of the seven peptide groups to the list.
Harshbarger wasn’t the only person asking questions about the unusual timing of the FDA’s peptide push, and who or what was behind it.
Weeks before the hearing, Wired reporter Kate Knibbs had filed a Freedom of Information Act request seeking FDA’s internal and outside communications about the peptide review. Her June 30 request sought records concerning the peptide nominations, their withdrawal, FDA’s proposed determinations, and communications with the nominators, compounding pharmacies, manufacturers, trade groups and lobbyists.
Weeks earlier, another requester, Shaumik Alam, a pharmacist and data engineer at drug maker Ajenat Pharmaceuticals, had already asked for the original nomination files, specifically noting their April withdrawal. Alam’s June 19 FOIA request sought “the original submitted agency records prior to their withdrawal.”
And four days after the hearing, Brandon Wissbaum of Gray Media’s InvestigateTV filed a similarly broad request, seeking FDA’s internal and outside communications concerning the seven peptides. His July 28 FOIA request also sought “any draft versions that preceded the final briefing document,” as well as “calendar entries, meeting notes, or records of any meetings (in person, by phone, or video conference) between FDA staff and outside parties concerning these substances – including their nomination, evaluation, withdrawal and FDA’s proposed determinations.”
All three FOIA requests are in FOIAengine, PoliScio Analytics’ competitive-intelligence database that tracks FOIA requests in as close to real-time as their availability allows. As of this writing, the FDA hasn’t announced a determination on any of them.
Despite the FDA staff’s recommendation against adding any of the seven peptides to the 503A Bulks List, the newly remade advisory committee recommended six of them: BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax. Only Emideltide, also known as DSIP, failed to win a majority.
The decisive votes came from the committee’s eight new members, most of whom had ties to peptide-related businesses, clinics, or advocacy. Harshbarger was a solid Yes for all seven peptides. But not a single holdover or temporary member voted in favor of any of them.
When the advisory committee began voting on the peptides, investors were waiting to pounce on the news. And Wall Street initially seemed to like what it heard. Among publicly traded companies that might benefit from an FDA policy reversal, Hims & Hers (NASDAQ:HIMS), which owns a peptide manufacturing facility, surged as much as 13 percent on the first day of the hearing, while Enhanced Group (NYSE:ENHA) jumped nearly 19 percent and tiny Precision Peptide (CSE:BPC) saw its U.S. shares trade at 46 times the previous day’s volume.
Then the trades reversed. Hims fell 14 percent as the committee completed its voting; Enhanced dropped 13 percent; and Precision Peptide gave back most of its gain. A month later, none was above its Day One peak: Hims was nearly 20 percent below it, Enhanced had fallen nearly 90 percent from its May peak, and Precision Peptide had essentially returned to where it traded before the hearing.
The committee’s votes were recommendations only; FDA must still decide whether to formally add any of the peptides to the list.
Whether FDA will ultimately follow the advisory committee’s recommendations remains to be seen. So, too, does the answer to a more basic question: Why the agency pressed ahead with the peptide reviews after the companies that nominated them had withdrawn their requests – and who made that decision?
The Peptide List, a Substack publication that covers peptide science and regulation, offered a nuanced assessment. The committee members, it argued, were neither “fools” nor “villains.” They faced patients already buying poorly regulated compounds and concluded, six times out of seven, that a regulated supply was preferable to an unregulated one.
As the publication put it, “That may well be the right call. It is not, and this is the part worth holding onto, the same thing as the drugs working.”
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John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. He is the author of The Partisan: The Life of William Rehnquist. His latest book is Summer of ’71: Five Months That Changed America, about the fateful year before Watergate. Click here to watch the official book trailer. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at JAJ@PoliScio.com.