United States
Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.
The hub’s goals of efficiency, centralization and coordination fit with the Trump Administration’s current focus for the FDA, Amy Comstock Rick, director of strategic coalitions, told the Biopharma Congress.
The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.
The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.
Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.
Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.
The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.
The forced departure of CBER Director Peter Marks is a milestone event for the agency, as center directors now are likely to be treated as political positions subject to change with each new administration.
Eli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products.
Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
Most, if not all, adcomm support staff in the drug and biologic centers who handled meeting-specific tasks have been laid off, although sponsors still are preparing for the public reviews. Meanwhile, some cut FDA employees are being called back to work for "continuity of operations activities."
Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.
Pink Sheet reporter and editors discuss how the massive layoffs will reshape the FDA and its impact on the drug and biologics industries.
While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.
Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.
Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?
As CMS administrator, Mehmet Oz will oversee the second cycle of Medicare drug price negotiations and Part D redesign issues, but will have experienced deputies to help.
The departure data emerged along with a Health and Human Services Department memo describing conceptual plans to consolidate and restructure offices at the FDA and other agencies.
Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.