STAT+: Pharmalittle: We're reading about a Novo challenge to Medicare talks, a scuttled FDA office, and more

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of deadlines, online meetings, and phone calls has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction by brewing cups of stimulation. Our choice today is coconut rum, a welcome shot for the needy neurons. Meanwhile, here are a few items of interest to start you on your journey, which we hope is meaningful and productive. Best of luck, and do keep in touch. …

When should six drugs count as one? That question is at the heart of an unusual challenge that Novo Nordisk is pursuing against the federal government, STAT writes. And the answer could have major ramifications for the Medicare drug price negotiation program, a signature accomplishment of former President Biden that President Trump has also embraced. Novo argues the federal government should be forced to negotiate the price for six of its insulin products separately, even though they all contain the same active ingredient. The government says that the law allows it to lump all these products together. Although the lawsuit focuses on insulin products from the first year of the program, Medicare also lumped together three Novo blockbuster diabetes and weight loss products — Ozempic, Rybelsus, and Wegovy — in the second round of negotiations. Semaglutide is the active ingredient in all of them.

The U.S. Food and Drug Administration office that investigates complaints and disputes between reviewers and the drug industry is currently unavailable following massive layoffs across U.S. government health agencies, Bloomberg Law tells us. The office, known as the Center for Drug Evaluation and Research Ombuds, receives questions and investigates complaints from regulated industry, law firms, and health care providers to informally resolve disputes between those entities and the FDA’s drug reviewers. The disputes handled by CDER Ombuds range from regulatory and scientific issues to administrative topics. The layoffs targeted 3,500 employees at the FDA, which broadly hit staff working in program management, human resources, technology, policy, and communications, as well as several top leaders with years of institutional knowledge. Virginia Behr, who served as CDER’s ombudsman for over 18 years, retired from the agency April 10.

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