‘In­ac­cu­ra­cies’ push FDA to re­verse Trump-era ter­mi­na­tion of its Un­ap­proved Drugs Ini­tia­tive

Due to “mul­ti­ple le­gal and fac­tu­al in­ac­cu­ra­cies,” the Biden ad­min­is­tra­tion’s FDA said Wednes­day that it will re­verse the Trump-era de­ci­sion to pull the agency’s con­tro­ver­sial Un­ap­proved Drugs Ini­tia­tive.

The de­ci­sion to with­draw the Trump HHS no­tice ter­mi­nat­ing the ini­tia­tive comes as Biden’s FDA says it was nev­er con­sult­ed on the de­ci­sion in the first place, and it does not ac­cu­rate­ly re­flect HHS’ or FDA’s think­ing “be­cause it is in­con­sis­tent with the FD&C Act, FDA reg­u­la­tions, and ju­di­cial prece­dent, among oth­er le­gal au­thor­i­ties, and is not sup­port­ed by the facts,” ac­cord­ing to a Fed­er­al Reg­is­ter post­ing on Wednes­day.

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