STAT reported that the FDA’s new Commissioner’s National Priority Review voucher program has drawn political involvement at the highest levels, with White House and agency officials influencing voucher awards and pressuring staff on selections. Career staff expressed concerns about political interference in review prioritization, which could alter standard scientific decision‑making processes. The accounts cite internal staff and describe at least one voucher awarded despite staff objections. Separately, STAT and related reporting indicate the White House plans to announce drug pricing agreements with major manufacturers, including "most‑favored nation" style deals and price concessions in exchange for regulatory benefits such as expedited reviews. Companies weighing such deals face tradeoffs between price concessions, domestic investment commitments and accelerated regulatory pathways. Together, these developments signal heightened politicization of regulatory levers, adding uncertainty to go‑to‑market and pricing strategies for biopharma companies.
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