Ed Silverman , 2025-04-18 13:54:00
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up. We expect to promenade with the official mascots and catch up on our reading, and hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This is a lovely time to enjoy the great outdoors — beaches, parks, lakes, and woods are beckoning. Or if you prefer hustle and bustle, you could stroll city streets and engage in people watching. Those in need of still further distractions from recent events may want to take in a moving picture show or make time to see someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
The U.S. Food and Drug Administration will remove industry representatives from advisory committees and replace them with patients and caregivers, STAT writes. This is the latest effort by FDA Commissioner Marty Makary and his boss, U.S. Health and Human Services Secretary Robert F. Kennedy Jr., to reduce the influence of the pharmaceutical industry. Makary announced the change during his first interview as commissioner, with former Fox News host Megyn Kelly. He spent much of the conversation with Kelly lambasting his agency for its ties to industry, and said he was shocked to learn that drug industry representatives are allowed to sit on FDA advisory committees. The FDA is required by law to include non-voting industry representatives on advisory panels, in accordance with the FDA Modernization Act of 1997. The one industry representative on each panel of 11 to 13 members does not get to vote, and the industry member cannot be from the company whose product is under review.
The mass layoffs at the FDA included senior negotiators in talks with the pharmaceutical industry over renewing the user fee programs that fund the agency drug review system, Reuters reports. Among the 15 people fired were the head negotiator and deputy head negotiator for one of the user fee agreements. The firings of most of the negotiators and their project managers throw into disarray the complex process of reauthorizing the agreements, overseen by Congress, under which big pharma and generic drug companies pay for FDA product reviews. The loss of those FDA employees jeopardizes agency preparations for the looming reauthorization process for the program that funds its budget for one of its core functions, reviewing drug products that can be life-saving and approving treatments that are safe and effective. Drug and device companies build their business models on the predictability provided in the user fee agreements, in which the FDA commits to complete new drug reviews within either 10 months or six months depending on whether it is a standard or priority application.
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