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Wednesday
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22 October, 2025 |
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FDA Commissioner Marty Makary, CBER Director Vinay Prasad and senior advisor Sanjula Jain-Nagpal took to the airwaves on YouTube earlier this week, for the first time since Prasad departed and then returned to the FDA. The trio offered up some sharp critiques of anti-FDA Wall Street Journal editorials that referred to Prasad as "the grim reaper." Makary said the WSJ opinion desk has been the most critical of any news outlet or editorial team, adding, "I don't think they believe in an
FDA." Prasad also revealed that more details behind the new "plausible mechanism" drug approval pathway for rare diseases are coming in the next two weeks in the New England Journal of Medicine. |
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Zachary Brennan |
Senior Editor, Endpoints News
@ZacharyBrennan
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FDA Commissioner Marty Makary speaks alongside President Donald Trump during an announcement about in vitro fertilization in the Oval Office at the White House Oct. 16, 2025. (Francis Chung/POLITICO via AP Images) |
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by Max Bayer, Zachary Brennan
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FDA Commissioner Marty Makary unveiled the first nine companies to win his new National Priority Vouchers, a bigger cohort than originally planned as part of the agency’s effort to significantly cut some drug review times. The voucher program aims to review selected drugs in as little as one month after submission, instead of
the typical 10 to 12-month timeline. When it was first announced in June, the FDA said up to five companies would participate in the first year, according to a webpage screenshot from July. That language has since been removed from the FDA’s site. Makary has vowed to release even more vouchers in the coming weeks, aligning with President Donald Trump’s priorities for lowering drug prices and increasing US manufacturing. | |
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by Zachary Brennan
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The FDA's drug and biologics centers saw nearly 1,000 net departures in the last quarter of fiscal 2025, the latest agency hiring data show, revealing historic losses that overshadow hundreds of added staff in recent years. Neither center has ever recorded net losses at fiscal 2025 levels, and no quarter has been as low as the fourth quarter of this year. CDER lost 746 staffers (and gained six) — almost three times as many losses as the third quarter — while CBER lost 194 employees (and gained four), according to FDA data updated last week. The FDA exodus includes senior leadership, even as some teams were reinstated following the April reduction in force (RIF) across the agency. It remains unclear how these losses will affect the agency's drug and biologic reviews or other work, which have so far maintained pace with years past. And it's unclear if the latest data released by the FDA include the more than 3,000 FDA staff cut by the
RIF. | |
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by Zachary Brennan
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Pfizer CEO Albert Bourla called China's biopharma ecosystem "remarkable," telling CNBC's Invest in America forum on Wednesday that the US should focus less on slowing down China and more on how to adapt to the new competition. "They have done a tremendous job, not only in investing a lot, but in regulatory changes, IP protections, funding their national institutions, creating phenomenal universities," Bourla said of China, noting more patents were filed there than in the US last year. To get ahead, the US needs "regulatory changes, stability," Bourla said. "Tariffs and pricing were not helping," he added, referring to the Trump administration's trade and drug cost programs. Pfizer struck a deal with the Trump administration last month as part of the White House's "most favored nation" pricing push. | |
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President Donald Trump speaks in the Oval Office on Oct. 16, 2025 (Andrew Caballero-Reynolds/AFP via Getty Images) |
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by Max Bayer
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President Donald Trump announced a sweeping new effort to broaden IVF access by securing “massive discounts” on fertility drugs from EMD Serono, the latest deal in the White House's "most favored nation" drug pricing push. The announcement Thursday at the White House also came with a brief update on how the administration plans to
negotiate discounts for GLP-1 weight loss drugs, as well as the rollout of the FDA's new priority review vouchers that could provide an even faster pathway for companies to get products assessed. The IVF announcement was the most significant effort by the Trump administration to make good on a campaign pledge to widen access to fertility treatments, but falls short of Trump’s previous goal to make the treatments free. | |
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Mark Cuban at #HLTH25 (Michael Vanarey/HLTH) |
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by Zachary Brennan
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Billionaire entrepreneur Mark Cuban and his heavily discounted, mostly generic drug online pharmacy will link up with President Donald Trump's incoming online marketplace TrumpRx, aiming to connect more patients with better drug prices. Cuban announced the partnership on Sunday at the HLTH conference in Las Vegas, and called on the
administration to go further on drug pricing reform, particularly around pharmacy benefit managers. "If you pull out the money going to PBMs and their vertically integrated insurance companies, then our price right now would be almost as low, if not lower, than the MFN prices that they're looking to do," Cuban told CNBC. The Trump-Cuban partnership follows pledges from Pfizer, Amgen and |
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