| |  | | | | |  | By Megan R. Wilson | - Pfizer vs. Novo: Pfizer filed a second lawsuit against Novo Nordisk, alleging an “anticompetitive conspiracy” in the bidding war over a biotech start-up developing an anti-obesity medication.
- FDA shake-up: George Tidmarsh, head of the FDA’s Center for Drug Evaluation and Research, is reportedly out following concerns over comments he made about a Canada-based drug company.
- Medicare changes: CMS finalized the physician fee schedule, including changes to payments for specialty services and pricey bandages.
Good afternoon, and welcome to Health Brief. Send all your best health policy intel, tips and scoops to megan.wilson@washpost.com or message me 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. | | | |  | The Lead Brief | The fight for market share in the $150 billion anti-obesity drug market is getting even hotter. On Friday, I wrote about the bidding war between Pfizer and Novo Nordisk for biotech start-up Metsera — and, around the time the newsletter came out, federal antitrust regulators gave Pfizer an early okay to pursue the transaction. And then, the lawsuits came. → This morning, Pfizer filed a second lawsuit against Metsera’s controlling shareholders and Wegovy-maker Novo Nordisk, accusing them of anticompetitive conduct. Metsera is developing a once-monthly medication to help with weight loss that has shown in early clinical testing to have fewer gastrointestinal side effects than other drugs on the market. Pfizer, which is based in New York, is alleging that Novo Nordisk is deliberately attempting to “capture and kill” a competitor in the rapidly growing obesity drug market with its offer valued at up to $9 billion. Meanwhile, Pfizer offered $4.9 billion in cash, in addition to milestone payments that could push the value beyond $7 billion. “Instead of competing on price, Pfizer has taken the highly unusual and seemingly desperate approach in filing its antitrust lawsuit today,” Ambre James Brown, Novo Nordisk’s vice president of global media, said in a statement. “This offer highlights Novo Nordisk’s commitment to investing in the US," Brown continued. “Pfizer’s suggestion that Novo Nordisk would impair or potentially stop an emerging US competitor is absurd and not based on facts, common sense, or market realities." In a statement, Pfizer said the company is “confident in the merits of our case and look forward to presenting it to the Court.” The complaint asserts that Novo Nordisk’s unsolicited bid for Metsera is the result of the two companies engaging in an “anticompetitive conspiracy” that would ultimately suppress competition. Metsera called the lawsuit’s allegations “nonsense”: “Pfizer is trying to litigate its way to buying Metsera for a lower price than Novo Nordisk,” the company said in a statement. → It comes on the heels of Pfizer’s initial lawsuit on Friday, in which it claimed that Metsera breached its merger agreement by declaring Novo Nordisk’s offer “superior” — while Pfizer argues that Novo’s bid carried significant regulatory risk. Why it matters: - Competition in the obesity drug market: Novo Nordisk already holds market-leading products Wegovy and Ozempic, meant to treat obesity and weight loss, respectively. Pfizer is seeking entry into this high-growth space after deciding to shelve the anti-obesity pill it had in development earlier this year. The outcome of this fight could have a big impact on which companies have a larger foothold in next-generation therapies in a market projected to surge over the next decade.
- Strategic and regulatory stakes: It will be interesting to watch how Pfizer’s antitrust arguments play out. It’s trying to paint Novo, a Danish company, as using its global scale to consolidate dominance in the U.S. According to a Reuters report, Pfizer warned Metsera that a Novo-led transaction could draw additional scrutiny from the Committee on Foreign Investment in the United States, which reviews certain foreign transactions on a national security basis.
|  | | The Food and Drug Administration headquarters in White Oak, Maryland. (Andrew Kelly/Reuters) | | | | | | Agency Alert | George Tidmarsh, a top drug regulator at the Food and Drug Administration, resigned over the weekend, according to officials, amid growing scrutiny of public comments he made questioning the FDA approval of a treatment made by a Canadian company. That company, Aurinia Pharmaceuticals, has filed a lawsuit accusing Tidmarsh of making false statements and soliciting a bribe. The company alleges the actions stem from a “long-standing personal vendetta” against its board chairman, Kevin Tang, who previously pushed Tidmarsh out as CEO of another company in 2019 following “growing concerns over Dr. Tidmarsh’s management.” The lawsuit also claims Tidmarsh attempted to extort Tang over a product made by another company. My colleague Rachel Roubein in the Washington Post newsroom dove into the Tidmarsh news this morning. By Monday afternoon, Tidmarsh told Endpoints News he was second-guessing his decision to resign. He said would fight the probe into his alleged conduct. Health officials told Rachel that concerns about Tidmarsh’s conduct stemmed from a September LinkedIn post criticizing voclosporin, an FDA-approved drug made by Aurinia Pharmaceuticals for treating a condition that affects the kidneys in people with lupus. The post, which has since been deleted, described the medication as having “significant toxicity.” Tidmarsh, who joined the FDA’s Center for Drug Evaluation and Research in July, oversaw the approvals of over-the-counter medicines and the majority of prescription drugs. The LinkedIn post — notably, a regulator chiding a specific FDA-approved drug from a personal account — was seen by industry observers as highly unusual. The company’s stock dipped. Emily Hilliard, a spokeswoman for the Department of Health and Human Services, told Rachel that Tidmarsh was placed on administrative leave Friday after the Office of the General Counsel and the Office of the Inspector General were “notified of serious concerns about his personal conduct.” Tidmarsh resigned Sunday morning effective immediately, Hilliard said in a statement. The initial news of Tidmarsh being put on leave came from an interview he did over the weekend with the New York Times in which he denied any wrongdoing. He told the outlet he believes a review was opened in retribution for questioning a new program meant to accelerate the approval of treatments in mere weeks. Tidmarsh confirmed to Rachel he was placed on administrative leave, and his comments to the Times, but declined to comment further. Stat first reported the lawsuit, which has been filed in a federal Maryland court. | | | | | | Executive Health Brief | The Trump administration released the first of the two highly anticipated annual Medicare payment rules on Friday evening, finalizing an overall payment bump for providers, but making a number of other changes that some providers worry could hit their bottom lines. — ‘EFFICIENCY ADJUSTMENTS’ Some doctors with specialty practices will see a squeeze in Medicare payments next year, this time from a new “efficiency adjustment” tucked into the agency’s final physician fee schedule. The Centers for Medicare and Medicaid said the move is about reflecting real-world productivity gains. In other words, it believes many medical services can now be done more efficiently — thanks to technology, streamlined workflows and experience — than when they were last priced. To account for that, the agency is trimming the work component of payments for most non–time-based services by 2.5 percent. Services that depend mainly on time spent with patients — such as primary care visits or behavioral health appointments — are exempt and may see a boost. CMS plans to revisit the adjustment every three years. Some physician groups, including the American Medical Association, pushed back, warning the policy could compound existing cuts and make it even harder for practices to stay financially viable. When combined with other cuts, the adjustments could have a major impact, the AMA says, citing agency data: - Nearly 40 percent of oncologists would receive 10 to 20 percent reduction in Medicare payments
- More than half of internists and 81 percent of infectious-disease physicians are looking at reductions of 5 percent or more
Others applauded the move, saying it could “offer an immediate revenue boost to independent practices,” said Mark E. Miller, Arnold Ventures’ executive vice president of health care, “which could help reduce incentives for vertical integration — a frequent driver of rising health care costs.” — SKIN SUBSTITUTES Despite a high-dollar lobbying campaign, CMS is moving ahead with a major change to how Medicare pays for skin substitutes — the pricey wound-care materials that have seen explosive spending growth in recent years. Until now, most of these products were treated like biologics, each with its own billing code and payment rate. But under the final rule, CMS will instead treat them as “incident-to” supplies — meaning they’ll be bundled into the payment for the procedure rather than reimbursed separately. It’s also capping the reimbursement for skin substitutes at about $127 per square cm. The agency says the new approach better reflects how the products are actually used and will curb overbilling and ballooning costs. Medicare went from spending $256 million on the bandages in 2019 to $10 billion in 2024. The agency is on track this year to spend $15 billion on them, according to an analysis of federal data from the National Association of ACOs, an industry group. Why it matters: This isn’t just a paperwork tweak. Reclassifying skin substitutes effectively pulls them out of the biologics payment structure — a move that physicians warn could ripple through the entire coding system. Still, CMS argues the shift will promote consistency and save billions of dollars. Some physician groups warned that reclassifying skin substitutes could force cuts to payments for other services because the system must stay budget-neutral. CMS ultimately disagreed, arguing that any impacts will be phased in slowly and may actually stabilize payments over time as competition drives prices down. | | | | | | | | | ©2025 WP Intelligence, a division of The Washington Post | Privacy Policy |
| | | |
_tstmp_1756933376-1920-1080.png)
