A ‘mixed bag’ for weight-loss drug supply

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Aug 06, 2024 View in browser   By Lauren Gardner and David Lim Driving The Day Despite the FDA listing Eli Lilly's Mounjaro and Zepbound as available, some pharmacists say they still have difficulty obtaining the popular drugs. | Darron Cummings/AP DEFINE ‘AVAILABLE’ — All dosage forms of Eli Lilly’s popular GLP-1 drugs were considered “available” on the FDA’s drug shortages database as of Friday, but the active ingredient underpinning the products is still listed as in shortage. Pharmacists told Prescription Pulse on Monday that they still face obstacles ordering Mounjaro and Zepbound, Lilly’s brands to treat diabetes and obesity, respectively. Availability depends on the wholesaler a pharmacy uses and which dosages they need. That means patients nationwide aren’t uniformly seeing more supply available just yet. “It’s kind of still a mixed bag,” said a spokesperson for one major pharmacy chain who was granted anonymity to discuss a fluid situation. Pharmacist Dave Miller, of Keystone Pharmacy in Grand Rapids, Michigan, said Cardinal Health’s ordering platform on Monday showed that only three dosage forms were available for each drug. Even those marked available didn’t necessarily have many to spare; Miller said the wholesaler only had two injectable pens in stock for some dosages. Lilly “might have plenty in their warehouses, but it’s not making it to the wholesaler level yet,” he said. That sporadic availability means doctors might hesitate to start prescribing GLP-1s to patients, pharmacists said, since they must start at a low dose and gradually build to see optimal results with minimal side effects. “The supply chain is complex, especially for medicines that are temperature controlled, and there may be many reasons why a particular pharmacy does not have the medicine in stock,” a Lilly spokesperson said in an email. What does ‘available’ mean? The FDA considers several factors when moving a drug off the shortage list, even if “all dosages of a drug may currently be listed as available.” The agency is still determining whether available supply meets its definition of a resolved shortage, spokesperson Amanda Hils said. “FDA generally considers a shortage to be resolved … based on an evaluation of the entire market, assessing whether all backorders have been filled and supply is meeting or exceeding demand,” she said in an email. The major pharmacy chain spokesperson said the manufacturer hasn’t removed the backorder messaging from the wholesaler website, suggesting Lilly still isn’t providing orders in full. Why it matters: Compounding pharmacies can still legally make copies of the drugs for patients with valid prescriptions, which the FDA allows during a drug shortage. “We’re filling a lot of compounded GLP-1s at the moment, and it’s growing on a monthly basis,” said Jennifer Burch, who owns a compounding pharmacy and a retail pharmacy in Durham, North Carolina. “We’re taking care of hundreds of patients.” IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Toddler-borne illnesses have given a whole new meaning to what Lauren considers “brat summer.” Send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).   During unprecedented times, POLITICO Pro Analysis gives you the insights you need to focus your policy strategy. Live briefings, policy trackers, and and people intelligence secures your seat at the table. Learn more.     Eye on the FDA Rep. Jack Bergman is part of a push by lawmakers with military ties to persuade the FDA to approve psychedelic therapy for PTSD. | Healing Breakthrough BIPARTISAN PUSH FOR MDMA — The FDA is slated to decide by Sunday (in user fee tradition with a weekend deadline, likely Friday) whether to approve or deny a bid to market MDMA — commonly known as the party drug ecstasy — with talk therapy as a new treatment for post-traumatic stress disorder. The application was the subject of negative FDA advisory committee votes earlier this summer, but that hasn’t stopped an unlikely grouping of Democratic and Republican lawmakers from advocating for the therapy’s approval, POLITICO’s Erin Schumaker reports. We asked Erin to dive deeper into the bipartisan pressure campaign and the stakes of the agency’s decision: The congressional push for MDMA approval is bipartisan. What were the common threads you found among the lawmakers advocating for this? There’s a push from both sides of the aisle to do right by veterans with post-traumatic stress disorder. Some lawmakers, like Reps. Jack Bergman (R-Mich.), Jimmy Panetta (D-Calif.), Morgan Luttrell (R-Texas) and Dan Crenshaw (R-Texas), served in the military, while others, like Lou Correa (D-Calif.), didn’t serve but care deeply about veterans. The optics aren’t great for Congress and the Department of Veterans Affairs: It’s been decades since there was a new PTSD treatment, and high suicide rates among veterans suggest the government isn’t doing enough to help them. What do proponents fear will happen if Lykos’ application is denied? And what do the drug’s detractors warn could be a downside if it’s approved? A green light from the FDA would have made life easier for psychedelics researchers and galvanized support for their work. A “no” will likely give those researchers pause. Research won’t grind to a halt, but it won’t speed up, either. Detractors worry that if the agency approves Lykos Therapeutics’ regimen — despite concerns from the advisory committee that the therapy isn’t effective and that its risks outweigh its benefits — patients could be harmed. If the FDA denies the application, what’s next for psychedelics research and its champions in Congress? It's not the end of the road, members told me. The VA and the National Institutes of Health will continue doing psychedelics studies, and the Congressional Psychedelics Advancing Therapies Caucus and its allies in Congress will keep pushing for FDA approval. As Crenshaw said: “If they don’t approve this one, I think it just provides a better roadmap for the next one.” Drug Pricing PETITION FOR GENERIC WEIGHT-LOSS DRUGS — Consumer advocacy group Public Citizen is petitioning HHS to use its patent power to allow Medicare, Medicaid and other federal programs to buy generic copies of popular weight-loss drugs like Ozempic. The group argues that the authority — also known as section 1498 — allows the government “to make use of patented inventions in exchange for paying reasonable compensation to the patent holder.” “Pursuant to the terms of § 1498, Novo Nordisk would not be able to obtain injunctive relief to prevent these firms from supplying these federal programs; its only remedy would be reasonable compensation as determined by a court,” Public Citizen’s petition states. “The savings introduced by generic competition would significantly outweigh any reasonable royalty rate that a court would set in these circumstances.” Pharma Moves The National Association of Chain Drug Stores has named Stephanie Katz as vice president of reimbursement, innovation and advocacy. She most recently served as assistant vice president for policy and advocacy at the National Council for Mental Wellbeing. WHAT WE'RE READING Limits on the amount of financial rewards federal programs can give to those who reduce or stop meth use obstruct the government’s efforts to combat the fight against substance use disorder, STAT’s Lev Facher reports. Research published in JAMA Network Open showed that some semaglutide products sold by illegal online pharmacies contained more of the ingredient than the labeled amount and that they could possibly be contaminated.   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. SUBSCRIBE NOW.     Document Drawer Several FDA staff — including FDA Commissioner Robert Califf — met with members of drug lobby PhRMA on July 22 to discuss “vaccine review challenges and combating misinformation,” according to a new public calendar disclosure.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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