 | | | | |  | By Megan R. Wilson | Did someone forward this to you? Sign up here to get it in your inbox. In today’s issue: Pressure grows on telehealth provider Hims & Hers Health over compounded weight loss drugs as Novo Nordisk launches suit. … Regulators ask Novo for tweaks to its own GLP-1 advertisements. … Democratic governors press CMS to reverse course on nixing childhood vaccination tracking. … And more. Welcome to the post-Super Bowl edition of Health Brief. If there had been any doubt that health care represented about 20 percent of the economy, the many pharmaceutical (and health-related) commercials on Sunday certainly put that to rest. I counted at least a half-dozen, not including the MAHA ad featuring Mike Tyson. Do you have any story tips or health policy intel? Are you the person in charge of the marketing for Vanda Pharmaceuticals? I want to talk to you. Shoot me a note at megan.wilson@washpost.com. If you prefer to message me securely, I’m also on Signal at megan.434. 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. Learn more about WP Intelligence. |  | | Novo Nordisk sued telehealth company Hims & Hers Health on Monday. (Tom Little/Reuters) | | | |  | The Lead Brief | Novo Nordisk followed through with its threat to challenge Hims & Hers Health on its marketing of compounded GLP-1 medications, slapping the telehealth company with a lawsuit on Monday morning. The blowback happened superfast, and it’s not just coming from industry competitors: The top lawyer at the Department of Health and Human Services said on Friday that the agency referred Hims & Hers to the Justice Department, a day after the telehealth platform rolled out its copycat compounded Wegovy pill. In response to federal regulators, a Hims & Hers spokesperson told me that the company has “a deep commitment to the safety and best interests of consumers and in compliance with applicable law” — and that it will continue working with the Food and Drug Administration. → Then, on Saturday, Hims & Hers announced that it “decided to stop offering access” to the compounded semaglutide pill following “constructive conversations with stakeholders across the industry.” But Novo Nordisk moved forward with a lawsuit on Monday alleging that the company is infringing on its patent for semaglutide, the active ingredient in Wegovy and Ozempic. Novo Nordisk’s primary U.S. patent on its main blockbuster semaglutide products won’t expire until 2032, after which generic manufacturers will be able to swoop in. Compound pharmacies make individualized versions of a medication, and have been offering “personalized” versions of GLP-1 drugs by producing them in nontraditional dosage amounts or adding ingredients such as vitamins. Novo Nordisk said that Hims & Hers “makes a mockery” of the FDA’s “world-class drug approval framework.” The pharma giant asks the court to order Hims & Hers and its affiliates to stop offering the copycat products, and award Novo with damages “adequate to compensate” for the patent infringement, among other requests. Meanwhile, Hims & Hers said in a social media post that Novo Nordisk is “weaponizing the US judicial system to limit consumer choice,” appealing to the America First crowd by saying the lawsuit is a “blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care.” | | | | | | Executive Health Brief | The crackdown appears to be broader than just reining in Hims & Hers. Last week, FDA Commissioner Marty Makary said the agency “will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.” - The FDA said it would begin restricting the ingredients needed to make “non-FDA approved” GLP-1 drugs if they’re being used by compounded medications “that are being mass-marketed by companies.”
HHS and FDA had no additional comment about action on compounding as of Monday. → Compounding pharmacies that make individually formulated medications are overseen by state pharmacy boards. Outsourcing facilities that make larger batches must register with federal regulators. While Hims & Hers argues that its compounded GLP-1s come from FDA-registered facilities, the products are not evaluated by regulators for safety or effectiveness. | | | | | | Industry Rx | THE BUSINESS ANGLE: The popularity of GLP-1 medications for weight loss has spurred a gold rush among companies trying to capitalize on the demand. Even the industry’s top two companies — Eli Lilly and Novo Nordisk — have been jockeying for domination of the market. (So far, Eli Lilly has come out ahead.) The industry players have good reason to want to protect their share of the market from companies making knockoff products. If successful, Novo’s lawsuit against Hims & Hers could have wide-ranging impacts on the industry, including chilling the production of GLP-1 copycats via compound pharmacies. In its statement on Monday, Hims & Hers said that the lawsuit could undermine the entire practice of compounding — which helps create individual formulations of various types of medications. The suit attacks “more than just one medication or company – it directly assaults a well-established, vital component of U.S. pharmacy practice that has improved patient care for everything from obesity to infertility to cancer,” said Hims & Hers in the social media post. John Kuckelman, Novo Nordisk’s general counsel, pushed back: “Nothing in our lawsuit would prevent pharmacies from compounding other medicines to meet the needs of U.S. patients,” he said in an emailed statement. In a Q&A with Kuckelman, reporters at STAT noted that the lawsuit could open the door for Hims & Hers to challenge Novo Nordisk’s patent on semaglutide. “You’re right — you do have to think about asserting a patent,” Kuckelman responded, “but we have full confidence in the validity of our compound patent.” THE CONSUMER ANGLE: In addition to claims by telehealth providers that compounded GLP-1s give patients a “personalized” option, there is another major selling point: They are cheaper than name-brand GLP-1 products. While Hims & Hers insists its products are safe, they are not evaluated for safety or effectiveness like other drugs — including generic medications — are. Kuckelman claimed on Monday that testing by Novo Nordisk and “multiple credible third-party organizations” has “found that compounding of semaglutide poses unique and serious safety, quality and efficacy risks to U.S. consumers which are not present in other compounded drugs.” | | | |  | Agency alert | The FDA sent Novo Nordisk a letter about an advertisement for the pill version of its GLP-1 weight loss drug Wegovy, claiming that the claims in the spot “misleadingly imply that Wegovy in pill form uniquely enables patients to achieve outcomes that were not previously possible with other GLP-1 treatments for weight loss.” “FDA is not aware of data to support the implication that Wegovy, in pill form, is superior to other currently approved GLP1 treatments for weight loss,” the regulator wrote in the “Untitled Letter” — which is less severe than a warning letter — last week. “If you have data to support these claims and presentations, please submit them to the FDA for review.” Although the company wouldn’t confirm which advertisement the FDA is reviewing, one that aired during the Golden Globes last month hits several of the agency’s points. The agency also said the ad “misleadingly imply benefits beyond physical weight loss such as emotional relief, reduced psychological burden, hope, or direction for patients’ lives, positioning the drug as a solution to broader life challenges rather than a treatment for a specific condition.” Liz Skrbkova, Novo Nordisk’s head of U.S. media and stakeholder relations, said the company “take[s] all regulatory feedback seriously and [we] are in the process of responding to the FDA to address their concerns regarding the advertisement’s presentation.” | | | | | | Document Drop | FIRST IN HEALTH BRIEF: A coalition of governors is urging the Centers for Medicare and Medicaid Services to reverse its decision to stop tracking childhood immunization rates in federal health programs for low-income children, arguing the move will leave states flying blind on vaccine coverage and outbreaks. The Governors Public Health Alliance sent a letter to CMS Administrator Mehmet Oz last week, saying that the federal government changed the reporting requirements without consulting states or soliciting public comment. The governors’ argument: They say standardized federal reporting is essential for managing Medicaid programs, comparing performance across states and allocating public health resources. Without it, they argue, states lose data on national vaccination trends and the ability to coordinate across borders — especially as outbreaks of illnesses like measles cross state lines. The context: In a December letter, CMS told states it would stop requiring them to report childhood vaccination rates from the “Core Set” of quality measures starting in 2026, shifting that data to an optional, voluntary measure. The letter also tells states not to use vaccination measures to reward or penalize insurers or health plans, such as by giving bonuses to managed care plans that hit vaccination targets. Why it matters: The so-called Core Sets are federal scorecards meant to track how well Medicaid and CHIP, the government-run health programs for low-income Americans, deliver care. According to KFF, changes to the Core Set are typically discussed by federal working groups first — which didn’t occur this time. While the Governors Public Health Alliance bills itself as nonpartisan, all 15 of the founding members are Democratic governors. Those governors, which represent roughly one-third of the U.S. population, have pledged to continue “tracking childhood immunization data to ensure states have the information needed to protect kids and respond to emerging risks.” What’s next: CMS will be exploring ways “to facilitate the development of new vaccine measures that capture information about whether parents and families were informed about vaccine choices, vaccine safety and side effects, and alternative vaccine schedules,” it said in the December letter. The agency is also planning to meet with states, immunization registry managers, providers and electronic health record vendors “to learn how new measures could capture person and family preferences related to vaccines,” according to the letter. “CMS will also explore how religious exemptions for vaccinations can be accounted for in the data and the subsequent measures.” | | | | | | Jobs Report | Priscilla VanderVeer has been named executive director of No Patient Left Behind, a coalition of biotech companies, investors, providers and patients. She comes from Walgreens but has also worked at the Pharmaceutical Research and Manufacturers of America and APCO Worldwide. VanderVeer succeeds Peter Rubin, who has led No Patient Left Behind since its launch in 2020. Rubin will serve on the group’s board. | | | | |
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