Policy

President Donald Trump’s tariffs on pharmaceuticals “to come at some point,” per CNBC, as companies promise to build infrastructure in the U.S.
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IRA
While the former Biden administration showcased the Inflation Reduction Act as a key victory in the fight over high drug prices in the U.S., Trump has so far been mum on how the controversial law could evolve in the coming years.
FDA
Ahead of Robert F. Kennedy Jr.’s confirmation hearings, experts—and RFK’s own family—expressed concerns about his vaccine-related views, though the same experts are largely unfazed by the level of power he and Marty Makary could ultimately wield over the FDA.
Less than a day into his second term, President Donald Trump ordered a freeze on communications at major public health agencies, among other moves that have sent waves through the biopharma industry.
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The Outsourcing Facilities Association, a trade group representing compounders, filed a similar lawsuit in October last year after the FDA formally ended the tirzepaptide shortage.
Samsung Bioepis allegedly entered into an agreement with a third-party health company, allowing it to market its own private label of a Stelara biosimilar.
President Trump also refused to promise pharma execs that he would hamstring the IRA’s drug negotiation program.
Around 300 FDA staffers laid off last week are being asked to return. So far, the Trump administration has terminated some 1,000 employees from the agency.
The postponed ACIP meeting comes barely a week after Robert F. Kennedy, Jr. was confirmed as Secretary of Health and Human Services, despite controversy regarding his anti-vaccine history.
FDA
Morale is low at the FDA, which was hit with layoffs this week following RFK Jr.’s confirmation. Biopharma leaders and agency insiders fear further workforce cuts could delay new medicines.
Despite expectations of dealmaking leniency, new FTC chairman Andrew Ferguson told staff that he will retain the current 2023 FTC and DOJ guidelines on mergers, upholding stricter anti-trust scrutiny on deals.
Recently appointed HHS Secretary Robert F. Kennedy Jr. in 2018 helped bring several cases against vaccine maker Merck, alleging injury linked to its HPV shot Gardasil.
FDA
The hammer came down on an unspecified number of FDA employees this weekend, days after Robert F. Kennedy Jr. was confirmed as HHS Secretary.
Continuing our SCOPE 2025 coverage, Rohit Nambisan, CEO at Lokavant addresses not only current challenges, but the life sciences industry’s responsibility to maintain scientific integrity.