Disclosing Accelerated Approval on Direct-to-Consumer Prescription Drug Websites
| Autor: | Kathleen T. David, Helen Sullivan, Nisha J. Patel, Amie C. O’Donoghue |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Prescription drug Prescription Drugs Time Factors Epidemiology Disclosure Direct-to-Consumer Advertising Reading level Article 03 medical and health sciences 0302 clinical medicine PROMOTIONAL MATERIALS medicine Humans Pharmacology (medical) 030212 general & internal medicine Medical prescription Drug Approval Marketing of Health Services Internet business.industry Information Dissemination United States Food and Drug Administration Presubmission Pharmacoepidemiology Readability United States Health Literacy 030220 oncology & carcinogenesis Family medicine Accelerated approval business |
| Zdroj: | Pharmacoepidemiol Drug Saf |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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