Richard Pazdur, former FDA Oncology Center head with 26 years at the agency, resigned after being pressured to endorse a policy reducing required clinical trials from two to one for drug approvals.
Pazdur told The Wall Street Journal he was given a press release with a fabricated quote attributed to him and instructed to 'just agree to it.'
FDA Commissioner Marty Makary announced the change in December, making one well-controlled trial the default, supplemented by confirmatory evidence like mechanistic data.
HHS spokesperson stated Pazdur was indecisive on reforms and that Makary's leadership delivers cures urgently with career scientists' recommendations.
The policy shift, formalized recently, aims to speed drug access amid Trump administration efforts to cut bureaucracy, though experts question its scientific and legal basis.