> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Academics Urge Tougher FDA Stance on Accelerated NDAs
- URL: https://www.fdaweb.com/academics-urge-tougher-fda-stance-on-accelerated-ndas/
- Published: 2022-12-09T12:00:00.000Z
- Updated: 2026-09-14T18:09:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153360

Two 12/8 *JAMA* viewpoint articles examine potential tweaks to FDA’s accelerated approval program to make it easier for the agency to pull an approval if a confirmatory study does not demonstrate clinical benefit.

One [article](https://jamanetwork.com/journals/jama/fullarticle/2799570?utm%5Fsource=silverchair&utm%5Fmedium=email&utm%5Fcampaign=article%5Falert-jama&utm%5Fcontent=olf&utm%5Fterm=120822), authored by Harvard Law School’s **Daniel G. Aaron** and **I. Glenn Cohen**, and Brown University’s **Eli Y. Adashi**, examines the struggles FDA encounters when seeking the withdrawal of a therapy, illustrated by the recent three-year ordeal to remove Covis’ Makena (hydroxyprogesterone caproate) after confirmatory trial data showed it was not effective ([see earlier story](https://www.fdaweb.com/fda-panel-shoots-down-makenas-continued-availability/)). The authors support an approach in a bill that circulated during the user fee reauthorization on Capitol Hill that would set expiration dates on accelerated approvals to make withdrawals automatic if a sponsor fails to provide sufficient evidence to persuade the agency otherwise.

The [other viewpoint](https://jamanetwork.com/journals/jama/fullarticle/2799571?utm%5Fsource=silverchair&utm%5Fmedium=email&utm%5Fcampaign=article%5Falert-jama&utm%5Fcontent=olf&utm%5Fterm=120822), from University of Pennsylvania Carey Law School’s **Holly Fernandez Lynch** and Washington University Law School’s **Rachel E. Sachs**, looks at adding teeth to voluntary withdrawal commitments that a company may offer during the review period if a subsequent confirmatory study fails to show a benefit. This recently came into play at a recent advisory committee meeting discussing Amylyx’s amyotrophic lateral sclerosis also known as Lou Gehrig's disease) drug Relyvrio (sodium phenylbutyrate and taurursodiol) and where FDA was provided assurance from the company that if the drug were approved and the confirmatory trial failed to show a benefit, then the company would remove it from the market ([see earlier story](https://www.fdaweb.com/2nd-time-a-charm-in-als-drug-panel-vote/)).

“If the FDA plans to consider company pledges to voluntarily withdraw their products from the market when deciding whether to grant approval, the strength of those pledges must be improved,” the authors write. They say Amylyx’s pledge was “ambiguous” and did not define “not successful,” leaving room for disagreement. “For example,” they continue, “even when primary end points are not met, companies sometimes point to other data, such as promising trends shy of statistical significance, success on secondary end points, or post hoc evidence of benefit. They may also argue that a trial was flawed, necessitating further study.”

Fernandez-Lynch and Sachs recommend that FDA “only consider withdrawal pledges made in writing, which should be incorporated into approval documents and associated commitments. Moreover, it should include explicit waivers of procedural rights, including the right to a hearing, if the FDA subsequently proposes withdrawal.” They also say “triggering conditions for voluntary withdrawal” should be explicit with an objective definition, “such as failure to meet the primary end point to a level of statistical significance.”