White House proposes easier access to unapproved peptides

A temporary policy posted to a White House docket on Oct. 14 proposes allowing licensed pharmacies to manufacture and sell specific unapproved peptides. The measure seeks to bypass the standard federal approval process for these substances. If finalized, patients could purchase these compounds without a formal drug approval from the Food and Drug Administration.

FDA scientists advised against the proposal during a meeting in July. They warned that the drugs had not been adequately vetted in clinical trials. However, an advisory panel that guides the FDA voted to loosen restrictions on the substances. The panel includes several new appointees with financial interests in the peptide industry.

HHS spokesperson Emily Hilliard stated in an email that every committee member satisfies the agency's ethics requirements. Haleem Mohammed, a new committee member and chief medical officer of Gameday Men's Health, voted in favor of the change. He said at the meeting that he voted yes for patient safety and medical freedom.

Proponents of peptides often argue that the substances are not drugs because they are natural. Gary Brecka, co-chair of the MAHA Action committee, has said on his podcast that peptides help regulate cortisol and improve circulation. Jacob Sherkow, a law professor at the University of Illinois Urbana-Champaign, noted that humans make many peptides, including insulin. He observed that insulin is considered a drug when injected to regulate blood sugar.

Promoters frequently claim that peptides are safe because the body produces them. Katrin Svensson, a peptide scientist at Stanford University, pointed out that researchers have not found the popular experimental peptide BPC-157 in the human genome. She explained that natural substances can be toxic, citing insulin as an example that can cause death in high doses. She added that researchers need to show peptides are not harmful before widespread use.

Many influencers and doctors claim these peptides treat specific illnesses. Kris Wusterhausen, a new appointee to the FDA panel and founder of an antiaging company, stated that BPC-157 can reduce acid reflux and treat neurologic disorders. A 2005 summary of a small clinical trial on BPC-157 for inflammatory bowel disease was called inadequate by FDA reviewers. Another small study found relief for 14 of 16 patients with knee pain, but it lacked a control group.

Flynn McGuire, a rehabilitation doctor at the University of Utah, told patients he will not prescribe BPC-157 until quality studies are conducted. He said people want new treatments quickly, but medicine and science do not work fast. Laboratory studies showing promise do not guarantee safety or efficacy in humans. Many substances that work in early experiments fail in clinical trials.

Health Secretary Robert F. Kennedy Jr. suggested on social media that the FDA hinders access to peptides because they cannot be patented. Hundreds of peptide patents exist in the U.S. Patent and Trademark Office database. A patent for an early formulation of BPC-157 is currently for sale. Sherkow explained that while natural things cannot be patented, modified and stable formulations can be.

Pharmaceutical companies are suing one another over patents for GLP-1 peptides, which are the basis for weight loss drugs like Ozempic. Morgan Stanley projects the market for these medicines will reach $190 billion within the next decade. Pinchas Cohen, a scientist at the University of Southern California, said investors withdrew funding for trials on a peptide he discovered because they feared it could not compete with GLP-1 medications.

The pharmaceutical trade organization PhRMA advised against easing restrictions on unapproved peptides in a letter to the FDA. The group said the move would erode incentives for manufacturers to undertake the time and cost required for FDA approval. Six in 10 U.S. adults said they worried about affording prescription drugs in a recent KFF poll. Four in 10 said they have skipped doses due to price.