An FDA advisory committee will meet this week to decide whether seven popular peptides can be legally compounded by pharmacies, revisiting restrictions imposed by the Biden administration in 2023. The decision could reshape access to treatments like BPC-157, TB-500, and MOTs-C, which have surged in…
The Food and Drug Administration's Pharmacy Compounding Advisory Committee is set to meet Thursday and Friday of this week. The panel will evaluate whether seven popular peptides can be reclassified in a way that allows pharmacies to legally produce customized treatments for patients. This process, known as compounding, involves mixing drug ingredients to create tailored medications.
Peptides are short chains of amino acids that serve as the building blocks of proteins and regulate various biological functions in the body. Many are being used to address issues such as weight loss, sleep disorders, and aging. Among the peptides under evaluation are BPC-157 for inflammation, TB-500 for wound healing, and MOTs-C for obesity. These substances have gained significant popularity in recent years, particularly among fitness enthusiasts and online influencers.
The meeting will reassess a decision made three years ago by the Biden administration. In 2023, the FDA determined that nearly 20 peptides posed safety risks and could no longer be legally compounded. That determination moved the substances into Category 2 of the 503A bulk list, which prohibits their use in compounding. The move was challenged in court by compounders who alleged that the FDA violated federal procedures when it pulled the substances. The lawsuit was later settled.
Now, nearly 1,900 public comments and expert testimonies have been submitted to influence whether the Trump administration reverses that decision for certain peptides. The two-day discussion will revisit the debate over safety and what restrictions should be in place.
The demand to expand access to peptide therapies has been largely spearheaded by US Health Secretary Robert F. Kennedy Jr. In February, Kennedy called himself a "big fan of peptides," having used them for his own injuries. The treatments have also gained momentum within the "Make America Healthy Again" movement that Kennedy champions.
Lee Rosebush, chairman of the American Academy of Peptide Medicine, commented on the effort. "What we're trying to do is provide safeguards and rails for these peptides, that way patients can have safe access to these through compounding pharmacies here in the United States," Rosebush said.
However, the meeting has already drawn scrutiny. The FDA stacked the advisory committee with several members who have ties to peptide businesses. Additionally, the agency released documents ahead of the discussion in which staff stated that there is not enough evidence to support compounding these peptides.
There is no exact figure for how many people have accessed unapproved peptides. But compiled data from specific manufacturers and clinics shows that more than 20 million doses of medicines containing the nominated substances were dispensed or administered over the last eight years. This has paved the way for a multibillion-dollar industry to form.
While the advisory committee can make recommendations to the FDA, the agency has the final say on whether the select peptides can be compounded.
Peptide therapies are not new, but their popularity has exploded in the last several years. This growth followed the success of glucagon-like peptide-1 drugs, or GLP-1s, used for weight loss and diabetes. Eli Lilly & Co.'s Mounjaro and Zepbound, along with Novo Nordisk A/S's Ozempic and Wegovy, are all FDA-approved and generated well over $30 billion in combined GLP-1 sales last year.
An assortment of unapproved peptides is also trending in an unregulated marketplace. These products come in various forms, including injectables, creams, capsules, and nasal sprays. The Biden administration's 2023 decision prohibited them from being manufactured, citing safety risks and a lack of human studies to support their use.
Seven of those peptides, plus five more that were nominated in February, now have another opportunity as the FDA reconsiders whether to place them in Category 1. Category 1 designation would make them eligible for compounding.
The National Association of Boards of Pharmacy commented on the demand. "Demand is large and growing, and the potential volume is likely to dwarf the volumes seen with GLP-1s," the association told the FDA.
Peptide makers are asking the agency to reclassify the substances so that compounding standards can be established. They argue that this would help rein in a gray market fueled by vendors who sell unapproved substances labeled "for research use only" to bypass regulatory oversight.
Compounders warn that any decision that forcibly closes a compounding pathway will not stop people from using these peptides. Instead, it would push patients toward products with unknown origins.
Edwin Lee, co-founder of the Clinical Peptide Society, spoke about the importance of quality control. Lee was the first person to publish a human trial of BPC-157 injected into the knee. "These peptides have the potential to help Americans become healthier, but they should be obtained only through licensed compounding pharmacies that are inspected by state boards of pharmacy and the FDA to help ensure quality, sterility, and patient safety," Lee said.
Others are urging the agency to consider a broader selection of health products available to consumers, highlighting the growing distrust in mainstream medicine. Jeff Cohen, co-founder of the American Peptide Association, explained this sentiment. "We go hunting for solutions that are a little bit off-road, and peptides are one of those things," Cohen said.
Despite the push for wider access, the industry faces a skeptical FDA and several health groups that have raised concerns about the lack of rigorous human clinical trials and data regarding the purity of some peptides.
Rita Jew, president of the Institute for Safe Medication Practices, posed a fundamental question. "The most important question to ask is not whether pharmacies should be able to compound these peptides, but whether the peptides have first been shown to be safe and effective for the uses being promoted," Jew said.
Peter Lurie, a former associate commissioner at the FDA who now serves as president of the Center for Science in the Public Interest, defended the traditional drug approval process. "Those drugs have gotten to market the old-fashioned way, they established sufficient safety and efficacy," Lurie said.
Still, peptide makers are asking the FDA to approach the products with a fresh perspective. Cohen, from the American Peptide Association, offered a closing thought. "Look at the meeting as a beginning," Cohen said. "Instead of being adversarial, look at it as an opportunity to collaborate and communicate."
Peptides referenced: BPC-157, TB-500, Semaglutide, Tirzepatide, MOTS-c, Glucagon, GLP-1.
Vendors referenced: Peptide Makers.
Related reading: FDA Advisory Committee Set to Decide on Peptide Reclassification This Week, FDA Issues Warnings to 25 Firms Over Compounded GLP-1 Claims, FDA Approves First Oral PCSK9 Inhibitor Lipfendra from Merck, Mounjaro vs. Semaglutide: Understanding the Key Differences.