OPDP to Study Accelerated Approval Disclosures in DTC Ads

The CDER Office of Prescription Drug Promotion (OPDP) is soliciting comment on a proposal to study accelerated approval disclosures on direct-to-consumer (DTC) prescription drug Web sites. A Federal Register announcement of the study comes just days after the controversial 6/7 FDA accelerated approval of Biogen’s Aduhelm (aducanumab-avwa) to treat Alzheimer’s disease.

OPDP says that some DTC Web sites have included disclosures about accelerated approval and of those, many included similar content to that in the Indications and Usage section of the approved labeling. The notice says the purpose of the proposed project is to replicate and extend prior general-population research through studies that (1) test the same experimental conditions with a study population of cancer survivors and caregivers and (2) test additional consumer-friendly disclosures.