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President Donald Trump's pharma-specific tariffs are back in the spotlight, with his continued push to drive home foreign manufacturing. But analysts seem to think the tariffs won't take effect anytime soon. And earlier today, the Senate HELP Committee advanced Susan Monarez, Trump's selection to run the CDC (see more below). |
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Zachary Brennan |
Senior Editor, Endpoints News
@ZacharyBrennan
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President Donald Trump at a Cabinet meeting on July 8, 2025 (Evan Vucci/AP Images) |
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by Max Bayer
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President Donald Trump said pharmaceutical companies will have a grace period of at least a year to move their manufacturing to the US before facing tariffs on their drugs. The new detail disclosed Tuesday by Trump came as he promised the tariffs on drugmakers, which have been in development since early this year, would come "very soon." Trump has
repeatedly said over the last few months that the tariffs were coming shortly. A grace period would give companies at least some time to shift manufacturing — though it often takes years to build and bring new drug plants online, far longer than Trump is proposing. |
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by Zachary Brennan
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President Donald Trump on July 4 signed into law his wide-ranging tax cuts and reconciliation package, including an expansion of orphan drug protections from Medicare negotiations, and nearly $1 trillion in Medicaid cuts that could upend the operations of hospitals that provide cheaper drugs and care under the 340B federal program. The orphan drug provision is a significant win for the drug industry. Under the law, which is formally called the One Big Beautiful Bill Act, any orphan or rare disease drugs, potentially including blockbusters with multiple orphan indications, won't face Medicare price negotiations under the Inflation Reduction Act. Neither of the first two rounds of drugs selected for negotiation included orphan drugs. But the pharma industry raised concerns that the way the IRA was written could limit
the exclusion to only drugs with one rare disease indication. |
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Susan Monarez (Photo by Kayla Bartkowski/Getty Images) |
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by Alexis Kramer
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Susan Monarez's nomination for CDC director cleared the Senate health committee on Wednesday, putting her one step closer to leading the agency after an upheaval of its vaccine advisers. If confirmed by the full chamber, Monarez will be tasked with overseeing a newly rebuilt Advisory Committee on Immunization Practices (ACIP) and helping to restore public trust in the agency’s decision-making. The Senate Committee on Health, Education, Labor and Pensions voted 12-11 in Monarez’s favor. Monarez “is committed to improving transparency at the CDC and properly communicating health guidance to the American people,” Sen. Bill Cassidy (R-LA) said in a statement before the vote. |
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by Zachary Brennan
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FDA Commissioner Marty Makary pledged to "meaningfully reduce" unnecessary animal testing that's currently used to bring new drugs to market and to test them in early developmental stages. While Makary's proposal is light on specifics, a reduction of animal testing could lower R&D costs, speed up drug
development, and "potentially even translate into lower drug prices," Makary said at an FDA-NIH workshop at the FDA's headquarters on Monday. "One of our biggest goals is to reduce animal testing in a way that's meaningful and continues to protect against public safety," he added. Makary's FDA in April said animal testing requirements, which vary depending on the type of drug in development, will be "reduced, refined, or potentially replaced" via "a range of approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting." |
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by Zachary Brennan
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Thousands of FDA staff departures since April have sparked concerns within the pharma industry that novel drug approval deadlines might slip. But in the first six months of 2025, the approval numbers remain generally aligned with previous years, even as FDA officials warn that the full extent of the staff cuts has yet to be realized. As of July 2, the FDA has approved 24 new drugs and biologics so far in 2025, compared with 36 novel products approved by CDER and CBER over the same time period in 2024, and 40 in 2023. Approval numbers may vary year-to-year, depending on previous years' submissions, and often serve more as a sign of industry productivity and FDA's workload. |
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