Federal regulators are considering allowing compounding pharmacies to manufacture several peptides that are currently popular with consumers. George Frey/Bloomberg/Getty Images hide title toggle title George Frey/Bloomberg/Getty Images Every day, Dr. Alexander Weber faces another round of questions about peptides and whether trendy therapies can help his patients recover from sports injuries or surgeries. He doesn’t
Federal regulators are considering allowing compounding pharmacies to manufacture several peptides that are currently popular with consumers.
George Frey/Bloomberg/Getty Images
hide title
toggle title
George Frey/Bloomberg/Getty Images
Every day, Dr. Alexander Weber faces another round of questions about peptides and whether trendy therapies can help his patients recover from sports injuries or surgeries.
He doesn’t offer them in his practice as an orthopedic surgeon, but he shares what research shows about how well they really work.
“My usual response is that we just don’t have enough data,” says Weber, chief of sports medicine at the University of Southern California.
“The anecdotal evidence, even from the patients I see, is that they feel these injectables help them, but we just need to study it,” he adds. Weber authored a review of the research, published earlier this year, and noted the lack of evidence supporting its clinical use.
However, the medical establishment’s words of warning appear to have done little to quench the public’s appetite for these therapies, which have not undergone the large-scale trials necessary to gain approval from the Food and Drug Administration.
They are widely promoted in wellness and longevity circles for injury recovery, muscle growth, skin health, metabolism, and more. Health Secretary Robert F. Kennedy Jr. extolled their benefits in an interview with Joe Rogan earlier this year and promised to reverse Biden-era restrictions that have prevented compounding pharmacies in the U.S. from manufacturing them.
In fact, the restrictions have relegated the substances to a gray market, fueled by foreign suppliers, raising new safety concerns as users inject unauthorized substances.
However, the era of peptide bans could soon be over.
Later this month, a new panel of outside experts appointed by the FDA will make recommendations on whether seven peptides, including some of the most popular injectables like TB-500, BPC-157 and MOTs-C, should be added to a list that gives compounding pharmacies the green light to, again, manufacture the products.
“No one is recommending these peptides. It’s about ensuring that patients have safe and effective access to these medications,” says Lee Rosebush, a pharmacist and attorney who represents peptide manufacturers and other industry players.
“The FDA’s actions during the Biden administration opened up the Wild West,” he adds.
For new discoveries, everyday mysteries and the science behind the headlines, follow NPR’s Short Wave podcast.
An air of credibility
Peptides are a chain of amino acids (smaller than a protein) that often act as signaling molecules in our body and help regulate the immune system, metabolism, and many other critical functions. They can be synthesized and administered as drugs. Some of them, like insulin, are found naturally in the body. Others are modified versions, as is the case with the successful weight loss drug GLP-1.
One of the most sought-after synthetic peptides under consideration this month, called BPC-157, is based on a peptide found in human stomach juices. Another, TB-500, is related to a molecule found in many types of cells, called thymosin beta-4.
Weber believes that the massive success of the GLP-1 diabetes and weight loss drugs has lent an air of credibility to these injectable wellness peptides, even though those drugs underwent extensive human trials before coming to market. That’s not the case for any of the seven peptides considered this month.
“Every time I see these people on social media saying they’re experts in this field and they’ve been doing it for a long time, sure, you can say those things, but show me the data,” he says.
In a review of the evidence last month, the FDA’s own scientists recommended against changing the status of any of the seven peptides under consideration at the July meeting.
But it’s unclear how the FDA’s newly formed panel, called the Pharmaceutical Compounds Advisory Committee, will weigh the agency’s evaluation of the data.
Many of its members have ties to the peptide industry and work for clinics that offer injectable peptides or for compounding pharmacies that could benefit.
“I think what’s happening here is that the advisory committee may be filled with people who are known to have certain views on an issue rather than addressing it in an impartial and conflict-free manner,” says Dr. Aaron Kesselheim, an expert on FDA law and professor at Harvard Medical School and Brigham and Women’s Hospital.
In a statement to NPR, a spokesperson for the Department of Health and Human Services said that all committee members “have undergone a vetting and ethics process” and that the agency is “committed to having robust and transparent discussions about products.”
While the panel is tasked with making recommendations, FDA leadership has the final say on what happens.
Risks versus benefits
Outside groups have echoed concerns raised by the agency’s career scientists. For example, the nonprofit Institute for Safe Medication Practices published a white paper on peptides for wellness earlier this year, drawing attention to gaps in the evidence and warning that much of the data comes from preclinical studies conducted in animals, not humans.
“With anything you’re taking, whether it’s an FDA-approved product or a supplement, you always have to weigh the risk versus the benefit,” says institute president Rita Jew.
“These peptides really have no established efficacy, so the only thing there is is risk,” he says.
Peptide advocates like Rosebush counter that pharmaceutical companies have no interest in conducting the kind of expensive studies on these peptides that are needed to legitimize them because many of them cannot be patented.
“These products will likely never go through the FDA approval process,” he says. “So if pharmacies are not allowed to do this, patients will never have access.”
The agenda for the July 23-24 meeting specifies that the committee will review the data behind these injectable peptides for specific indications, such as migraines, ulcerative colitis and osteoporosis.
But if the FDA eventually reclassifies these peptide therapies so that they can be combined, Kesselheim says patients will have no problem finding doctors who feel comfortable prescribing them for all types of conditions.
“That’s why this discussion is so important and why it’s important to exercise the FDA’s authority here appropriately with optimal outside counsel,” he says.
{For more tech updates, stay tuned to our blog.|Keep following us for the latest insights.|Check back often for more exciting news!}
