Sen. Ron Wyden (D-OR) (Francis Chung/E News/POLITICO via AP Images)

Sen­a­tor Ron Wyden press­es FDA and DEA on gener­ic Adder­all short­age

Sen. Ron Wyden (D-OR) is putting pres­sure on reg­u­la­tors to ad­dress an on­go­ing short­age of am­phet­a­mine mixed salts, a gener­ic form of Adder­all that treats AD­HD.

The sen­a­tor said in let­ters last week to DEA Ad­min­is­tra­tor Anne Mil­gram and FDA Com­mis­sion­er Robert Califf that he is “deeply dis­ap­point­ed on be­half of the Ore­go­ni­ans I rep­re­sent” over the agen­cies’ re­sponse to the short­age.

“While I ap­pre­ci­ate that your staff fol­lowed up with more in­for­ma­tion on the role the Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) plays in pre­vent­ing and mit­i­gat­ing drug short­ages, it falls short of the state­ment and ac­tions need­ed. Specif­i­cal­ly, the process is mud­dy and ob­scure as to how gener­ic man­u­fac­tur­ers are nav­i­gat­ing the process to re­quest a quo­ta in­crease, and the fact that your agency does not seek out or re­port re­gion­al da­ta is a grave con­cern,” the let­ter said.

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