WASHINGTON — A new program intended to fast-track drug reviews at the Food and Drug Administration is quickly becoming a way for the White House and top political officials at the agency to exert control over which medicines make their way fastest to patients in the United States.
The FDA has historically aimed to keep drug reviews in the hands of career scientists to avoid political interference, or even the appearance of political interference. But STAT has learned that high-level FDA officials have been involved in every part of the new program to award “Commissioner’s National Priority Review” vouchers. They have awarded at least one voucher over the concerns of staff, and pressed staff to award vouchers to certain companies as part of the drug-pricing agreements being struck by the White House.
The political pressure is creating uncomfortable situations for career scientists at the FDA, and some say it runs roughshod over normal processes meant to ensure the safety and efficacy of drugs. The accounts below, many of which have not previously been reported, are based on conversations with six government officials who requested anonymity because they were not authorized to speak publicly.
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