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Disclosing accelerated approval on direct‐to‐consumer prescription drug websites
Author(s) -
Sullivan Helen W.,
O'Donoghue Amie C.,
David Kathleen T.,
Patel Nisha J.
Publication year - 2018
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.4664
Subject(s) - medicine , prescription drug , medical prescription , drug approval , drug , pharmacoepidemiology , pharmacology , internet privacy , computer science
Purpose 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. Methods 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. Results 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. Conclusions 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.