Disclosing accelerated approval on direct-to-consumer prescription drug websites.

Abstract

We examined direct-to-consumer (DTC) websites for brand-name accelerated approval prescription drugs to determine whether and how accelerated approval is communicated to consumers. From the 34 brand-name prescription drugs under the Food and Drug Administration's accelerated approval pathway presubmission requirement for promotional materials in December 2016, we identified a sample of 26 that had active DTC websites. Two raters independently coded the websites for the presence, placement, content, and readability of an accelerated approval disclosure. Most (73%) of the websites contained an accelerated approval disclosure. Most of the disclosures (84%) included the basis for accelerated approval, whereas 68% stated that the clinical benefit of the product was unknown and 47% conveyed the need for additional research to confirm study findings. On average, the disclosures required at least a high school reading level, and most conveyed the information in medical terms. Direct-to-consumer websites for brand-name accelerated approval prescription drugs do not consistently communicate the accelerated approval information for the product to consumers in a prominent, comprehensive, or readable manner.