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Home » Authors » Mari Serebrov

Articles by Mari Serebrov

FDA icons

Loss of experience at US FDA raises concerns as impacts felt

April 10, 2025
By Mari Serebrov
“We’ve lost 1,000 person-years of expertise in a few weeks,” former U.S. FDA Commissioner David Kessler said in an April 9 House Oversight and Government Reform hearing as he discussed the impact of the termination of 3,500 FDA employees the previous week, on top of the 1,000 who were let go or offered retirement in February.
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Pill bottle spilling over EU flag

Many US tariffs paused, pharma warned, EU put on notice

April 9, 2025
By Mari Serebrov
The on-again, off-again U.S. tariffs are off again, at least for now, for more than 75 countries that have reached out to the Trump administration to negotiate instead of retaliating. The 90-day pause will provide some breathing room for the med-tech industry. Pharmaceuticals and active pharmaceutical ingredients were among the few products exempted from the reciprocal tariffs, but that exemption for pharmaceuticals was expected to be short-lived. Meanwhile, pharma CEOs warned European Commission President Ursula von der Leyen April 8 that, unless the EU quickly changes its policy, pharmaceutical research, development and manufacturing is increasingly likely to be directed to the U.S.
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Collection of vials

Much-needed predictability lacking in US biosimilar market

April 8, 2025
By Mari Serebrov
Ill-considered government policies, pharmacy benefit manager market abuses and an unpredictable future are casting doubt on the long-term sustainability of the U.S. biosimilar market, Craig Burton, the executive director of the Biosimilars Council, told a House Ways & Means subcommittee April 8.
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Judge's gavel with US flag

US court says no to NIH indirect rate cut, another suit filed

April 7, 2025
By Mari Serebrov
The nationwide preliminary injunction keeping the U.S. NIH from slashing its indirect cost rate to a flat 15% has become permanent. In issuing the permanent injunction and final judgment April 4 in three challenges to the rate change, Judge Angel Kelley, of the U.S. District Court for the District of Massachusetts, said the NIH’s Feb. 7 notice that it would begin imposing the 15% rate Feb. 10 to all existing and future grants violated the Administrative Procedure Act, as the action was arbitrary and capricious, was impermissibly retroactive and failed to follow notice-and-comment procedures.
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Caution tape displaying US flag, tariffs

Biopharma exempt from US reciprocal tariffs, but not untouched

April 3, 2025
By Mari Serebrov
At first glance, it appears that biopharmaceuticals dodged the latest U.S. tariff bullet; med-tech, not so much. According to the executive order President Donald Trump signed in the Rose Garden late yesterday, pharmaceuticals are one of the few things exempt from the new country-by-country reciprocal tariffs that will be going into effect over the next week. However, U.S.-based manufacturers of both drugs and devices could face supply chain disruptions, further market restrictions and increased operating costs as the new tariffs take effect and other countries retaliate.
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Pills, bottle atop $100 bill

US to impose ‘kind reciprocal’ tariffs on country-by-country basis

April 2, 2025
By Mari Serebrov
After several on-again, off-again tariff threats, U.S. President Donald Trump made it official April 2: Beginning immediately, the U.S. will levy “kind reciprocal” tariffs on countries across the world. Focusing on the numbers, Trump didn’t mention whether any goods would be exempt from the new tariffs, and the executive order he signed at the Rose Garden ceremony wasn’t available as of press time. However, in concluding his remarks, Trump said the pharmaceutical industry would “come roaring back” in the U.S., because if biopharma companies don’t, they will be facing big taxes.
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US flag and HHS logo

Kennedy called to Senate HELP hearing on HHS reorg

April 2, 2025
By Mari Serebrov
U.S. Sens. Bill Cassidy, R-La., and Bernie Sanders, I-Vt., invited Robert Kennedy to testify April 10 before the Senate Health, Education, Labor and Pensions (HELP) Committee for the first time in his capacity as Health and Human Services (HHS) secretary. The HELP invitation went out April 1 amid an outcry as thousands of employees across HHS agencies were being notified of their immediate termination and many lawmakers demanded answers about the mass layoffs.
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HHS Secretary Robert Kennedy

Where’s the ‘radical transparency’ Kennedy promised?

April 1, 2025
By Mari Serebrov
As the U.S. Department of Health and Human Services begins implementing its reorganization and reduction-in-force plan by sending out termination notices this week to 10,000 more employees across its agencies, top Democrats in Congress are demanding details about the plan.
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Marks’ departure intensifies regulatory uncertainty at US FDA

March 31, 2025
By Mari Serebrov
Peter Marks’ March 28 letter giving one week’s notice of his resignation as director of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) is sending more ripples of uncertainty throughout the industry. Marks, who has helmed CBER for nearly a decade, blamed his departure on recently confirmed Health and Human Services (HHS) Secretary Robert Kennedy, who has made a career out of his anti-vaccine stance.
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Website of The Federal Trade Commission

Trump halves the FTC, firing Democratic commissioners

March 19, 2025
By Mari Serebrov
The politicization of the U.S. FTC continued March 18 with President Donald Trump firing the two remaining Democratic commissioners, Rebecca Kelly Slaughter and Alvaro Bedoya. The action leaves what’s supposed to be a five-member bipartisan panel with just two members, both of whom are Republicans. The commission already was down one member, as former Chair Lina Khan’s term expired last year and Trump’s appointee, Mark Meador, is awaiting Senate confirmation with a vote expected yet this month.
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