| The fight over peptides is reaching a pivotal moment, with career scientists urging regulators to keep restrictions in place even as the industry and its allies press the Trump administration to make the products more widely available. Scientists at the Food and Drug Administration dropped an analysis last week that cast doubt on plans to expand access to seven peptides by allowing compounding pharmacists to prepare them, my colleagues Rachel Roubein and Lauren Weber reported in The Washington Post newsroom. There is not enough evidence regarding safety or effectiveness of the seven peptides under consideration, the FDA officials said in the analysis, and recommended against easing the compounding restrictions on them. → It comes ahead of an advisory committee meeting later this month to discuss whether to give compounding pharmacies, which make bespoke versions of medications, the green light to manufacture certain peptides that regulators had banned amid concerns about their safety. There will be another round of meetings in February to weigh relaxing restrictions on additional peptides. Researchers, peptide industry interests, pharmacies and others had until today to submit comments to be considered at the meeting. The advisory committee contains newly handpicked members, including some who have ties to peptide-related businesses and clinics. Another is the son of a Republican congresswoman who has asked Health Secretary Robert F. Kennedy Jr. to loosen the restrictions on a half-dozen peptides. Emily Hilliard, a spokeswoman for the Department of Health and Human Services, told my colleagues that the advisory committee members underwent a vetting process and that candidates who could not meet existing ethics requirements were removed from consideration. “FDA is committed to robust, transparent discussions about the products it regulates to ensure Americans can make informed decisions about their health,” Hilliard said. Read the full story: “RFK Jr.’s plan to boost peptide access just got more complicated.” → The restrictions on peptides haven’t stopped Americans from trying to procure them — largely from gray market websites — and inject themselves in the name of wellness. The products are labeled “for research purposes only.” This includes Kennedy, who has talked about being a “big fan” who has used them himself and who previously vowed to end the “war on peptides.” The products come with obscure names such as MOTS-c (used to enhance physical performance and slow the aging process) and BPC-157 (used to speed healing and recovery), which regulators prohibited from the consumer market in 2023. “There’s just so little data that it’s hard to even put your finger on all the possible risks,” Paul Knoepfler, a professor at the University of California at Davis School of Medicine focused on stem cells, told The Post earlier this year about the potential dangers of expanding peptide access. Critics contend that many peptides have not been adequately studied and carry potential safety risks. Supporters counter that stronger regulatory oversight would better protect consumers by channeling demand toward reputable manufacturers. “A ban may make critics feel better. It may produce a satisfying headline. It may even allow some organizations to declare a patient-safety victory,” Scott Brunner, the CEO of the Alliance for Pharmacy Compounding, an industry group, wrote in a LinkedIn post. “But it may also leave patients exactly where too many are now — on the internet, outside the pharmacy, outside the prescriber-patient relationship, and outside any meaningful oversight,” he said. “That does not strike me as patient safety.” Read previous Health Brief peptide coverage: “Peptide industry eyes gold rush.” I spoke with Jeff Cohen, a co-founder of the American Peptide Association, about the move to loosen restrictions and the upcoming advisory committee meetings. He said the industry group is submitting comments to the FDA for consideration. “We realize that if we don’t, as an industry, define safety for us in a meaningful way, it’s going to get defined at us by people that are either ill-informed or have other agendas, and they’re going to miss the mark. And then, ultimately, the consumers are going to have to live with that imprecision,” Cohen said. The following interview has been edited for length and clarity. What did the FDA scientists get wrong, in your view, when they concluded that there isn’t enough evidence to support allowing these peptides to be compounded? They got it wrong from the beginning because we think they’re asking the wrong question. It seems to us that the question they’re asking is: How can we validate safety and efficacy of products that have the same characteristics as pharmaceutical products? What we think they should be asking is how to validate safety and efficacy of a product that is not a pharmaceutical product without destroying consumer access. And how is it different? The pathway that they’ve got in place [for peptides] isn’t a fit. When you’re looking at a pharmaceutical product — where a molecule is created and then intellectual property protection is established — it makes sense that you’d spend $10 million researching it over five years, because you’re going to get that money back, and you’re going to make a profit. Well, how do you do that in a product like peptides, … for which there’s no intellectual property protection? How do you do that? You don’t. The FDA process, the committee’s process, is designed for a specific product in a specific kind of clinical ecosystem, and that doesn’t match this. We’re hoping through the American Peptide Association to respectfully communicate that and to offer participation in a compatible, companion-type analytic process that’s more fitting and that preserves consumer access. Now, there’s probably some skepticism about allowing the industry to create rules for itself. How do you respond to that? The American Peptide Association is legitimately about safety, quality and access. If it doesn’t line up with it, it’s not going to stick. We are adherents to the level of integrity and the quality of these products. … The people who are founders of this organization understand this one essential thing: If it’s not really safe, there will be no consumer access, because it’s going to be picked apart. And honestly, if they don’t regulate it, it deserves to be picked apart. The American Peptide Association knows we better come up with those standards for manufacturing: what needs to be tested and what the outcomes of that testing need to be, because it’s totally all over the place right now. There needs to be standards established, and then there needs to be a body that says you meet them or you don’t. What happens if the FDA does give the green light for some or all of the peptides under consideration to be compounded? The biggest thing that happens is a collective sigh from clinicians. The clinicians are really focused on this, and they’ve been shy to adopt. It’s more often than not any physician who’s working in this space — in the functional space or in the wellness space — that is comfortable recommending and prescribing peptides. It’s really licensed clinicians who are most impacted by the recategorization, because they’re concerned about the impact on their license and their reputations and their careers. The money market [is really watching this closely]. … In an area where there’s very little intellectual property protection, they’re very sensitive to regulatory ambiguity and vagueness. If any of that could be cleared, … we’ll begin to see an uptick in the private equity community investing in and buying these companies. Researchers found that people who live close to a community pharmacy are more likely to use prescription medicines, and that better access may help reduce racial and ethnic gaps in treatment. When a larger share of people lived within 10 minutes of a pharmacy, prescription drug use was higher, according to the study from the National Pharmaceutical Council and the University of Washington, recently published in Health Affairs. → A 1 percent increase in pharmacy access at the state level was linked to a 0.7 percent increase in medication use, with the strongest effects among Black, Hispanic, and Asian and Pacific Islander populations, and a slight decrease in racial and ethnic disparities in medication use. While about 82 percent of Americans lived within a 10-minute walk or drive of a community pharmacy in 2023, access varied widely, especially in rural areas and for American Indian and Alaska Native communities. The study examined pharmacy locations across the United States and compared them with prescription drug use for 27 common health conditions — such as rheumatoid arthritis, stroke, opioid use disorder, chronic obstructive pulmonary disease (COPD) and various types of cancers — between 2010 and 2019. In 44 percent of counties around the country, fewer than half of residents in at least one community live within 10 minutes of a community pharmacy, concentrated in the rural Mountain West, parts of the Midwest and the South. Why it matters: Community pharmacists have been decrying an uptick in pharmacy closures in recent years, noting a 15 percent drop in the number of pharmacies compared with a decade ago. Other researchers have shown the considerable churn — openings and closings — that occurs among chain and independent pharmacies across the country. The data in this more recent study could be used to underscore pharmaceutical and pharmacy arguments for additional changes to pharmacy benefit managers, or PBMs. Researchers also suggest policymakers consider policies that would allow pharmacists to bill for primary care services they could provide to diversify their revenue streams. The study was supported by grants from the National Pharmaceutical Council and Gates Ventures. “Health workers fighting Ebola go on strike after months without pay,” The Post’s Rael Ombuor and Rachel Chason report. “MAHA Mondays at the Great American State Fair miss one obvious problem,” Tim Carman writes at The Post. “In private meeting, Trump officials push to onshore generic drugmaking,” Daniel Payne writes at STAT. “HHS admits Medicaid data-sharing mistake with ICE,” Robert King reports at Politico. “CVS wins appeals court fight over Arkansas pharmacy network law,” Allison Bell reports at BenefitsPro. “US Food and Drug Administration rejects petition to set Pfas limits in food,” Tom Perkins writes at the Guardian. This newsletter is published by WP Intelligence, The Washington Post’s subscription service for professionals that provides business, policy and thought leaders with actionable insights. WP Intelligence operates independently from The Washington Post newsroom. 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