Health and Human Services Secretary Robert F. Kennedy Jr. has supported broader access to peptides. A new policy will make it easier for small compounding pharmacies to prepare these medications.
Heather Diehl/Getty Images
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Heather Diehl/Getty Images
Unproven but popular peptides touted for wellness are available on the market. gray market, despite an official ban. Today, the Department of Health and Social Services is seeking to bring them out of the shadows.
HHS said in a new policy that it would exercise enforcement discretion for half a dozen peptides, essentially looking the other way when made by small compounding pharmacies.
Health Secretary Robert F. Kennedy Jr. has been a strong supporter of peptidesclaiming he used some of them himself.
Peptides are chains of amino acids, shorter than proteins, that can exert powerful effects on the body. Some occur naturally and others are synthetic variations. Wellness influencers and some clinicians have promoted unproven peptides for a wide range of uses, although evidence for their safety and effectiveness is scant.
So even though these peptides haven’t gone through the Food and Drug Administration’s rigorous drug review and approval process, they could become easier to obtain. But the policy’s focus on small producers could mean pharmacists will struggle to meet demand.
In July, a panel of FDA advisors voted in favor of expanded access to six peptides via compounding pharmacies. However, at the same meeting, the FDA’s own scientists recommended against easing existing restrictions.
The new policy states that the composition is a safer alternative to illicit “research-only” peptides available online. They often come from unreliable foreign suppliers.
Peptides, and some of their unproven uses, are:
- BPC-157, ulcerative colitis
- Epitalon, insomnia
- KPV, wound healing
- c-WORDS, metabolic health
- Semax, migraine
- TB-500, wound healing
Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals in central Florida, says people have been asking about these peptides for years. But since it was illegal to make them, his company didn’t make them.
The new policy does not change their legal status, but it does create a pathway for smaller pharmacists, called 503A compounding pharmacies. This does not apply to larger ones, called 503Bs, which contract out facilities producing larger volumes of drugs.
So at Fritzler, only its smallest compounding facility will be able to make the peptides – and only in small quantities, he says.
And that has implications for consumers.
“We won’t be able to meet the demand,” he says, explaining that Olympia will likely only make one of the six peptides and must first prepare its facilities. “I don’t think all the (503)As in the country can meet the demand.”
Alliance for Pharmacy Compounding CEO Scott Brunner wrote in a statement that his group is pleased with the administration’s decision to allow peptide compounding because it provides a “more responsible alternative” to patients seeking gray market peptides.
“It also brings patients into a system where pharmaceutical standards, regulatory oversight and reporting of serious adverse events apply,” he says.
Brunner cautioned, however, that it may be some time before pharmaceutical pharmacies begin dispensing these products to patients. This is because ingredient suppliers must ensure that their active ingredients meet the policy requirements – and pharmacies must check this too.
Several consumer advocacy groups, however, say the policy puts patients at risk. The nonprofit Public Citizen noted that Kennedy appears to have acted unilaterally rather than through the typical rule-making process.
“By allowing unproven and potentially dangerous peptides to be manufactured, marketed and prescribed without regard for potential federal enforcement action, Kennedy undermined the FDA and threatened public health,” Dr. Robert Steinbrook, director of the health research group at Public Citizen, wrote in a statement. “All peptide substances should go through the FDA’s standard approval process for new drugs. The HHS Secretary should support, not sabotage, necessary FDA enforcement actions to protect consumers.”
Steinbrook advised clinicians to talk to their patients and inform them of the risk of contamination and other adverse effects.
The Partnership for Safe Medicines, which includes various drug and pharmacist organizations across the country, filed a citizen petition last week urging the FDA to ignore its advisory committee’s July recommendation to allow compounding pharmacies to manufacture the six peptides.
“Today’s decision leaves Americans in a gray area over whether or not peptides are safe, even though the FDA’s own scientists recommended against voting in favor of these substances due to concerns about the evidence,” its executive director Shabbir Safda wrote in a statement.
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