As drug shortages swell, FDA seeks more clarity from manufacturers

During dozens of drug shortages, which include cancer medications, emergency treatments and 14 others after a U.S. pharma company closed, the FDA drafted a guidance asking manufacturers to alert the agency on drug supply disruptions. 

If the guidance is approved, drug manufacturers would be legally required to immediately notify the FDA of permanently discontinued products and interruptions "likely to lead to a meaningful disruption in supply," according to the draft published April 6 in the Federal Register. 

The draft guidance also asks for notifications on permanently discontinued manufacturing of active pharmaceutical ingredients and possible supply disruptions of APIs.

At a Senate committee hearing in March, pharmaceutical supply experts testified about decadeslong issues with drug supply chains, including the lack of transparency from drug manufacturers and how it leads to a "never-ending game of drug shortage Whac-A-Mole," one expert said.

The agency is asking for comments on the draft until June 5.

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