FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway

Author:

Mahase Elisabeth

Publisher

BMJ

Subject

General Engineering

Reference8 articles.

1. US Food and Drug Administration. CDER drug and biologic accelerated approvals based on a surrogate endpoint as of December 31, 2020. 2021. https://www.fda.gov/media/88907/download

2. Federal Register. Pfizer, Inc.; withdrawal of approval of familial adenomatous polyposis indication for CELEBREX. 8 Jun 2012. https://www.federalregister.gov/documents/2012/06/08/2012-13900/pfizer-inc-withdrawal-of-approval-of-familial-adenomatous-polyposis-indication-for-celebrex#:~:text=On%20February%202%2C%202011%2C%20FDA,subpart%20H%20was%20never%20completed

3. US Government Accountability Office. Drug safety: FDA expedites many applications, but data for postapproval oversight need improvement. 14 Jan 2016. https://www.gao.gov/products/gao-16-192

4. Institute for Clinical and Economic Review. Strengthening the accelerated approval pathway: an analysis of potential policy reforms and their impact on uncertainty, access, innovation, and costs. 26 Apr 2021. https://icer.org/wp-content/uploads/2021/04/Strengthening-the-Accelerated-Approval-Pathway-_-ICER-White-Paper-_-April-2021.pdf

5. Report: FDA lacks follow-up on unproven drugs. NBC News 2009 Oct 26. https://www.nbcnews.com/health/health-news/report-fda-lacks-follow-unproven-drugs-flna1c9453895

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