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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER