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# OPDP Study on Accelerated Approval Info DTC Web Sites
- URL: https://www.fdaweb.com/opdp-study-on-accelerated-approval-info-dtc-web-sites/
- Published: 2022-03-24T12:00:00.000Z
- Updated: 2026-09-14T17:38:04.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5151446

CDER’s Office of Prescription Drug Promotion (OPDP) is proposing to conduct a study entitled “Accelerated Approval Disclosures on Direct-to-Consumer (DTC) Prescription Drug Websites.” A recent OPDP analysis of DTC Web sites for accelerated approval products found that 21% contained disclosures about the accelerated approval that used language directly from the approved physician labeling, 79% of the disclosures used at least some medical language, but 27% of the Web sites reviewed did not include any disclosure about accelerated approval.

OPDP says it recently conducted a general-population study testing the disclosure of FDA accelerated approval information on a DTC prescription drug Web site which suggested that consumer-friendly disclosures helped participants understand information related to a drug’s accelerated approval, “but that participants’ understanding was low overall.” It says the proposed study is intended to replicate and extend OPDP’s prior research by: (**1**) Testing the same experimental conditions with a different study population (cancer survivors and cancer caregivers), and (**2**) testing additional consumer-friendly disclosures.

A *Federal Register* [notice](https://www.govinfo.gov/content/pkg/FR-2022-03-24/pdf/2022-06220.pdf?ref=fdaweb.com) invites comments on the proposed study design.