U.S. FDA wants more generic drug-device combos

Abstract

U.S. Food & Drug Administration Commissioner Scott Gottlieb is continuing his push for cheaper drugs by making approvals of generics easier. FDA is committed to giving guidance on how companies can develop copycat products on complex drugs at least two years before the branded product’s patent expires, Gottlieb said on Nov. 28. He spoke at FDA’s Generic Drug Science Day in Silver Spring, Md. Complex formulations and active ingredients make some drugs difficult to copy. Drug-device combinations, such as inhalers or autoinjectors, are particularly tricky, since the device can be protected with new patents while the drug itself is decades old. For instance, Mylan’s EpiPen autoinjector contains epinephrine, a hormone first synthesized over 100 years ago. Mylan protested when other companies submitted generic drug applications for an epinephrine autoinjector, arguing that design changes confuse users. Adrenaclick is a cheaper alternative to the EpiPen. But because of design differences, it’s not