Shire's attention deficit drug Adderall is running short in the U.S. So who's to blame? Shire says the Drug Enforcement Agency, which regulates the active ingredient in Adderall, dragged its feet on approving an increase in production. But the DEA rejects that blame, saying it approved enough to prevent supply problems.
As the Wall Street Journal reports, Shire not only supplies branded versions of Adderall, but also makes generics sold by Teva Pharmaceutical Industries and Impax Laboratories. In fact, Impax sued Shire late last year for breaching a supply contract for generic Adderall; in a regulatory filing, Shire blamed DEA's restrictions for the shortfall. "We're not getting the supply we're ordering to meet our strong customer demand," an Impax spokesman told the WSJ.
The shortage has pushed some patients toward newer and more expensive branded drugs, according to Sen. Amy Klobuchar, who wrote Shire last week urging action. But if the Adderall scarcity is like other recent drug shortages, it won't be fixed immediately. Indeed, Aetna recently wrote its members saying it expected the generic form of the drug "to remain in short supply in the coming months" and that members will have to pay more for branded substitutes. Shire says it's working with Klobuchar's office on a solution.