Some drugmakers quietly concerned about legal risk with speedy FDA review program

Reuters

16 January 2026 - More than half a dozen major drug makers are participating in the Trump Administration's speedier review program for new medicines, yet other leading pharmaceutical companies are hesitating over what they see as potential legal risks, six industry sources told Reuters.

Under the FDA Commissioner's National Priority Voucher Program unveiled in June, US FDA chief Marty Makary can issue approval decisions in one to two months on a limited number of drugs deemed critical to public health or national security, or if they were manufactured in the US or offered at low prices.

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Michael Wonder

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Michael Wonder