Compounding the GLP-1 craze

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Jul 26, 2024 View in browser   By Lauren Gardner and David Lim Presented by  Driving The Day Gail Bormel, acting director for the FDA’s Office of Compounding Quality and Compliance, says it’s unusual to see such widespread demand in GLP-1 drugs. | FDA handout FDA ON GLP-1 DEMAND — The historic demand for a new class of weight-loss drugs is, in the view of the FDA’s top compounding pharmacy official, unprecedented. The “unusual situation,” as described by Gail Bormel, comes as the patented medications known as GLP-1s can’t be made quickly enough to meet patient need. Novo Nordisk, maker of Ozempic and Wegovy, and Eli Lilly, maker of Mounjaro and Zepbound, have bought manufacturing facilities to boost their capacity. But the shortage of semaglutide- and tirzepatide-based drugs isn’t expected to resolve before the end of the year. Compounding pharmacies make copies of the drugs for patients with valid prescriptions, a practice permitted by law when products are in shortage. But Lilly and Novo have seized on the risks of the compounds, which aren’t FDA-approved and can carry risks when not prepared properly. Here’s a snapshot of what Bormel told Lauren about that tension and what the law allows: No approximation: The FDA does not have estimates of how much compounded GLP-1 product is being consumed. That’s because the agency doesn’t require reporting by small, typically independent outfits known as 503A pharmacies that receive one-off prescriptions written by providers who know they have the equipment to make a compounded version. “We certainly don’t obtain data or receive data from the state-licensed pharmacies, but we do have data to see what outsourcing facilities are making,” Bormel said. Those outsourcing facilities, known as 503B pharmacies, must follow the FDA’s so-called current good manufacturing practices and report adverse events associated with their products. They also must report what they’re making to the agency twice a year — but the FDA cannot disclose the volumes they’re producing, Bormel said. The advertising factor: Compounders cannot claim their products are generic versions of the brand names. Novo and Lilly have sued some businesses they allege have advertised their products in a misleading way. “Generally, the agency is working closely with state regulators on this,” Bormel said. Dueling demands: The FDA tries to be Switzerland while overseeing major manufacturers and compounding pharmacies that, for now, are players for a slice of the market. While the agency “generally” recommends that consumers use agency-approved drugs, Bormel said, “We have a situation where the drugs are not available” and where compounded versions are allowed. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. The Associated Press has some advice if you find yourself interested in scaling back the number of prescription drugs you take. Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM). A message from CVS Health: Paying less out-of-pocket means our members can focus on living healthier lives. Learn more about how CVS Caremark is ensuring access and affordability to critical medications for millions of Americans.   In the Courts An appeals court rejected a red-state bid to further restrict the abortion pill mifepristone. | Charlie Riedel/AP ABORTION PILL STANDING CHECK — A federal appeals court this week rebuffed an effort by Republican-led states to intervene in a blue-state effort challenging the FDA’s remaining limits on access to the abortion pill mifepristone. The 9th Circuit ruled Wednesday that the seven states led by Idaho don’t have standing because their argument “depends on an attenuated chain of healthcare decisions by independent actors that will have only indirect effects on state revenue.” Idaho claimed that removing the in-person prescribing requirement for mifepristone would lead to more women with contraindications taking the drug, meaning necessary follow-up care would cost the state partly through Medicaid expenditures. What’s next: Idaho has joined Missouri and Kansas in trying to revive a separate lawsuit that challenged FDA policy changes that made abortion pills available via telemedicine and mail delivery. The Supreme Court recently ruled that anti-abortion doctors didn’t have standing to bring such a challenge before another federal court but sidestepped the merits of the case, giving GOP state leaders an opening to continue challenging the pills’ availability.   Live briefings, policy trackers, and procedural, industry, and people intelligence from POLITICO Pro Analysis gives you the insights you need to focus your policy strategy this election cycle. Secure your seat.      In Congress A PROPOSED BREAKUP, AGAIN — Two senior Democrats are relaunching an effort to separate the FDA’s food and drug regulatory powers, even though one of them had positive reviews of the agency’s recent changes. Rep. Rosa DeLauro (D-Conn.) and Sen. Dick Durbin (D-Ill.) reintroduced legislation this week to split food oversight functions away from the FDA into a food-specific agency housed under HHS led by a Senate-confirmed commissioner. The initiative is a long shot, and the two Democrats have pitched the idea for years. But the reintroduction comes at a time when DeLauro says she’s happy with the steps the FDA has taken to bolster food oversight in the years since the infant formula crisis roiled the agency. The shortage was still affecting families when the pair last introduced the bill in 2022. The appointment of Jim Jones in 2023 as deputy commissioner for human foods was “a very, very positive step, which I applaud,” she said Thursday. But the FDA’s portfolio is vast, DeLauro said, to the detriment of food safety. “I just view it overall that FDA has such a large portfolio — they do drugs, they do tobacco, they do devices — and then I think that what’s often been the case is that food safety takes a second position,” she said.   A message from CVS Health:   Tobacco CDC STUDY: MENTHOL SMOKERS WANT TO QUIT — Adult smokers of menthol cigarettes had greater interest in quitting compared with smokers of nonmenthol cigarettes, according to a CDC study that examined 2022 National Health Interview Survey data. “This article underscores the urgent need to finalize the lifesaving rules to end the sale of menthol cigarettes and flavored cigars, improve access to quit smoking resources and ensure that quit smoking resources are culturally appropriate,” American Lung Association CEO Harold Wimmer said in a statement. BIRD FLU TWO MORE CASES — Colorado’s public health department said Thursday that two more people tested positive for avian flu at a poultry farm in the state. The infections, found at a second farm that previously reported a separate infection, bring the total number of confirmed human cases in the state this year to 10. Nine were documented at two poultry farms. A dairy farm worker also tested positive.   SUBSCRIBE TO GLOBAL PLAYBOOK: Don’t miss out on POLITICO’s Global Playbook, our newsletter taking you inside pivotal discussions at the most influential gatherings in the world. Suzanne Lynch delivers the world's elite and influential moments directly to you. Stay in the global loop. SUBSCRI     WHAT WE'RE READING Sen. Bernie Sanders (I-Vt.) is eyeing a seat on the Senate Finance Committee that will open upon the resignation of Sen. Bob Menendez (D-N.J.), Roll Call’s Caitlin Reilly reports. A new study suggests a shot given twice a year could prevent HIV infection in teen girls and young women, The Washington Post reports. A message from CVS Health: CVS Caremark works every day to put medicine within reach of people who need it. Our members have an average out-of-pocket cost of less than $8 for a 30-day supply of medication, and we’re actively working to bring down costs for plan sponsors and their members. Learn more about how we’re making medicine more affordable for all Americans.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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