FDA accelerated approval disclosures on direct-to-consumer prescription drug websites

Abstract

OBJECTIVES: The US Food and Drug Administration (FDA) provides a pathway, known as accelerated approval, intended to facilitate and expedite development and review for prescription drugs that treat serious or life-threatening illnesses such as cancer. Many direct-to-consumer websites for accelerated approval prescription drugs include a disclosure describing concepts related to accelerated approval, such as the basis of the approval, uncertainty about clinical benefits of the drug, and the need for confirmatory clinical trials. The current research examined the presence, wording, and prominence of an accelerated approval disclosure on a prescription drug website.

METHODS: We conducted two studies with different populations: Study 1 participants were 822 general population US adults. Study 2 participants were 615 US adult cancer patients and caregivers. In each study, we randomly assigned participants to view one of five versions of a website for a fictitious acute lymphoblastic leukemia prescription drug. The control website did not include the disclosure about accelerated approval. The four disclosure conditions varied by disclosure prominence (low vs. high) and disclosure wording (consumer-friendly vs. based on the physician labeling and disclosures in the real-world marketplace).

RESULTS: In comparison to a disclosure based on physician labeling, a consumer-friendly disclosure helped participants understand accelerated approval concepts. For example, more participants in the consumer-friendly disclosure than in the physician-labeling disclosure condition knew the drug has not been shown to help patients live longer (Study 1: 13.4% vs. 31.4%; Study 2: 12.2% vs. 34.4%). Comparisons with the control condition demonstrated that while including either the physician-labeling or consumer-friendly disclosure increased participants' awareness of the disclosure, only the presence of the consumer-friendly disclosure improved comprehension of accelerated approval concepts. There were few effects for increasing prominence of the disclosure.

CONCLUSIONS: Adding a consumer-friendly disclosure to promotional websites may help consumers, patients, and caregivers understand a prescription drug's accelerated approval status.