STAT+: Pharmalittle: We’re reading about FDA rehiring PDUFA staff, pharma and Medicaid prices, and more

The FDA is asking some of its recently fired staff responsible for critically important funding negotiations with drugmakers to return

May 5, 2025 - 14:05
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STAT+: Pharmalittle: We’re reading about FDA rehiring PDUFA staff, pharma and Medicaid prices, 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 meetings, deadlines, and messages has returned. But what can you do? The world, such as it is, continues to spin. So time to nudge it in a better direction with a cup of stimulation. Our choice today is Mexican cinnamon. As always, you are invited to join us. Meanwhile, we must get cracking and dig in to the tasks at hand. On that note, we have assembled a menu of tidbits to help you get started. We hope your day is productive and meaningful, and of course, do keep in touch if something important or saucy arises. …

The U.S. Food and Drug Administration is asking some of its recently fired staff responsible for critically important funding negotiations with drugmakers to return, Reuters reports. The staff being asked back are involved with renewing programs under which drugmakers provide user fees that pay for the agency’s drug review system. The FDA last month fired most of its senior negotiators, as well as their project managers. U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. directed the FDA to fire 3,500 employees as part of a massive restructuring of U.S. health agencies in March. HHS has said 20,000 employees have left the agency through layoffs, buyouts, and early retirement offers spearheaded by the Department of Government Efficiency. At least one negotiator and nine other recently fired staff who support negotiations were asked to come back.

President Trump has set his sights on the pharmaceutical industry to shoulder part of the cost of his tax cuts, pressing congressional Republicans to force drugmakers to accept lower prices on prescriptions covered by Medicaid, Bloomberg News reports. Trump asked House Republicans to mandate the government health program for low-income and disabled Americans get the lowest price for drugs that certain foreign countries are charged. The president made the request during ongoing talks over how to cut hundreds of billions of dollars in government spending to fund tax cuts. The strategy could potentially ease one of the most contentious issues dividing Republicans as they seek to offset some of the cost of the tax cuts: whether to force millions of low-income Americans off Medicaid health coverage. But it risks antagonizing a powerful Washington lobby. The pharmaceutical industry has fiercely fought efforts to lower the prices federal programs pay for drugs.

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