Exclusivity, Labeling Are Sticking Points In FDA-Industry Abuse-Deterrence Talks

Branded and generic drugmakers are at odds on whether generic non-abuse deterrent opioid formulations should be withdrawn as soon as an abuse-deterrent innovator drug becomes available or whether FDA should delay taking action until postmarketing studies show the product's tamper-resistant properties are in fact effective. The two sides also diverge on proposed development incentives, with innovators pressing for additional exclusivity for new abuse-deterrent products and generic companies urging FDA to establish a category for abuse-deterrent formulations in the Orange Book...