FDA’s decision to make Elizabeth Dickinson permanent chief counsel was welcome news to those within and outside the agency, who hailed her as the perfect person to oversee the raft of legal issues confronting the agency.
FDA Looks Inside For Chief Counsel, Taps Elizabeth Dickinson
Former FDA attorneys laud her appointment, saying she is highly regarded inside and outside the agency for her intelligence, warmth and expertise on Hatch-Waxman and other key issues.
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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.
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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."
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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.
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Pink Sheet reporter and editors discuss how the massive layoffs will reshape the FDA and its impact on the drug and biologics industries.
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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.
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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.
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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?