| The Trump administration is paving the way for compounding pharmacies to sell six controversial peptides as medical treatments and wellness products, despite concerns from some career scientists at the Food and Drug Administration about allowing them on the market. The Department of Health and Human Services on Wednesday announced that it would not pursue enforcement action against certain pharmacies and physicians compounding certain peptides that are currently restricted, provided they meet a series of manufacturing, testing and reporting requirements. The temporary policy — which appears to be imposed by Health Secretary Robert F. Kennedy Jr. himself — applies while the FDA develops a formal list of bulk drug substances that can be used in compounding. “The Secretary of HHS has determined that this limited enforcement-discretion policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to U.S. patients,” a document posted to the department’s website reads. → The six peptide products impacted by the change — BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 — were backed by a federal advisory panel called the Pharmacy Compounding Advisory Committee in July. But the panel faced scrutiny after FDA officials and outside watchdogs raised concerns about members’ ties to businesses that sell or prescribe peptides, including wellness clinics. These products have been marketed for a range of purported benefits, including wound healing, recovery, metabolic health, and the treatment of migraines or ulcerative colitis. However, some experts argue that there’s a lack of evidence supporting many of those uses. “Expanding access is not a substitute for evidence of safety and effectiveness, nor is it a solution to the illegal online market,” said Leigh Verbois, a former FDA official and board chair of ASOP Global, a coalition that includes drugmakers and retail pharmacies. “Compounded drugs are not FDA-approved, and a policy of enforcement discretion does not establish that these peptides are safe or effective.” However, Lee Rosebush, chair of the American Academy of Peptide Medicine, echoed Kennedy’s claims about making the market safer, saying the move “represents a vital step toward eliminating the unsafe gray and black markets [and] restoring safe patient access through legitimate, physician-supervised care.” There is now “significant momentum” behind what Rosebush calls expanded patient care options. The newly unveiled policy “requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting to hold compounders accountable and give patients an alternative to unregulated sellers,” HHS spokesperson Emily Hilliard told The Post’s Rachel Roubein. Read more: “RFK Jr. plans to make 6 unapproved peptides available for temporary sale.” Peptide products are being used experimentally by some Americans, sometimes purchased off the internet or at wellness clinics. Kennedy, who’s said he’s used some of them, previously criticized the Biden administration for clamping down on the industry, vowing to end the “war on peptides.” In 2023, the FDA moved 19 peptides to its list of ingredients too risky for compounding pharmacies to use in custom-made drugs, citing potential safety concerns and lack of clinical trial data in humans. The changes announced Wednesday give a boost to an industry that spans compounding pharmacies, wellness clinics and telehealth platforms such as Hims & Hers Health all looking to capitalize on the longevity craze. The peptide market is estimated to be valued at roughly $2 billion to $3 billion, according to Reuters. Hims & Hers CEO Andrew Dudum told The Post earlier this year that “the traditional health care system has moved in a way that is too paternalistic. … It doesn’t have room for consumer flexibility.” In August, Dudum told investors that his company has been preparing to sell certain peptide products, including BPC-157. The company’s stock rose 5 percent on Wednesday. Anant Vinjamoori, the company’s chief medical officer, said Wednesday that it’ll have “more news to come soon” on new peptide offerings. “We have spent years building the infrastructure we need in our very own U.S.-based peptide manufacturing facility, developing dosing protocols with clinical experts, and setting up frameworks to better understand these emerging treatments,” Vinjamoori wrote Wednesday in a social media post. “We’ll keep working to bring these treatments within reach of those who need them.” Proponents of peptide compounding argue that while the products are not approved by the FDA for safety and efficacy, the 503A bulk-compounding facilities impacted by the policy must abide by regulations set by state boards of pharmacy. These compounding pharmacies make custom versions of medications for patients. Scott Brunner, CEO of the industry group Alliance for Pharmacy Compounding, has been advocating for the change, but said that there are still questions about technical details — such as when pharmacies can begin dispensing the peptides, how ingredient quality and testing records will be verified, and how federal requirements will align with state pharmacy rules. “A credible federal policy with meaningful patient-safety safeguards gives states a sound basis for their own oversight and helps discourage a patchwork of state rules and restrictions that could undermine the access HHS is trying to provide,” he said. Meanwhile, Fred Mills, chief policy officer for Americans for Safe and Effective Medicines, an advocacy group backed by the pharmaceutical industry, cautioned against giving the compounding industry a green light on peptides. “American consumers should not be treated like guinea pigs,” Mills said. “It is possible to advance both patient safety and access to legitimate medicines, but this is not it.” Rep. Frank Pallone Jr. (New Jersey), the top Democrat on the House Energy and Commerce Committee, is asking a government watchdog to tabulate how much Americans are saving on prescription drugs on TrumpRx. TrumpRx, the administration’s portal connecting patients to direct-to-consumer platforms to purchase medications, is a signature part of President Donald Trump’s effort to lower drug prices. The administration has said that the website has generated $700 million in savings, but Pallone wrote to the Government Accountability Office and said that it hasn’t offered any information to back up this assertion. Pallone adds that the administration “continues to obstruct congressional oversight on this topic,” asking GAO to figure out data such as how many patients are using it, which drugs they’re buying, and whether prices are truly competitive and how those prices compare to peer nations. He also wants the office to probe how many discounts stem from new federal negotiations with drugmakers versus existing offers, what restrictions apply and how the administration oversees patient safety. What to watch: Analysis by the GAO could be completed during the next Congress — when Democrats are expected to take back control of the House following the midterm elections. A Democratic majority would give Pallone the gavel at the Energy and Commerce panel, which brings more leverage to pressure the Trump administration along with it. “After years of being ripped off, real Americans are finally reaping the rewards of President Trump’s bold actions to lower health care prices,” White House spokeswoman Allison Schuster said in response to an inquiry about the letter. “Democrats have failed to address soaring drug costs for decades and continue to offer zero solutions.” “Your phone knows you’re at the doctor, and data brokers are profiting from it,” reports Michael Scaturro at KFF Health News. “As Epic’s dominance grows, its iron grip is choking innovation in health technology,” STAT’s Casey Ross and Brittany Trang report. “She Trusted ChatGPT With Her Medication Decisions. It Cost Her Everything.,” Teddy Rosenbluth reports at the New York Times.
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