DTC For Accelerated Approval Drugs: US FDA Is Taking Another Look At Disclosure On Websites

The US Food and Drug Administration plans to conduct another study to determine whether disclosure that a product received accelerated approval impacts consumer perceptions of the drug. The research project comes as accelerated approval is in the public spotlight following the FDA’s approval of Biogen, Inc. and Eisai Co., Ltd.’s ’s Alzheimer’s disease drug Aduhelm (aducanumab) via this pathway.

The proposed study by FDA’s Office of Prescription Drug Promotion is specifically evaluating the responses of cancer survivors and their caregivers to a website for a fictitious oncology prescription drug that discloses the product received accelerated approval