ArticlePharmacoepidemiology and drug safety2018
Disclosing accelerated approval on direct-to-consumer prescription drug websites.
Article in Pharmacoepidemiology and drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- FDA Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites: Testing Presence, Prominence, and Wording.Therapeutic innovation & regulatory science · 2026Article
- Content Analysis of Promotional Materials for Prescription Drugs Authorized Under Emergency Use Authorization.Drug safety · 2026Article
- Cancer Survivors' and Caregivers' Understanding of FDA Accelerated Approval Disclosures.Journal of cancer education : the official journal of the American Association for Cancer Education · 2025Article
- Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017.JAMA health forum · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
purposeWe examined direct-to-consumer (DTC) websites for brand-name accelerated approval prescription drugs to determine whether and how accelerated approval is communicated to consumers.
methodsFrom 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.
resultsMost (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.
conclusionsDirect-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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.