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# Changes Urged in FDA Accelerated Approval Program
- URL: https://www.fdaweb.com/changes-urged-in-fda-accelerated-approval-program/
- Published: 2017-05-25T12:00:00.000Z
- Updated: 2026-09-14T22:25:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138791

Researchers say the FDA accelerated approval process has had generally positive results in speeding new drugs to patients, but it also has created financial issues for public insurers. Writing in a *New England Journal of Medicine* Perspective [column](http://www.nejm.org/doi/full/10.1056/NEJMp1700446?rss=searchAndBrowse&ref=fdaweb.com), **Walid Gellad** and **Arnold Kesselheim** say that “at a time when medications can cost thousands of dollars per year, accelerated approval can lead to a situation in which private payers may choose not to cover a drug because of high cost and lack of evidence of clinical efficacy, thereby thwarting the pathway’s goal of getting potentially important therapies to patients earlier, while major government payers are forced to cover the product, directing substantial tax dollars to drugs not yet shown to have clinical benefit. For public insurers, accelerated approval thus becomes not only a pathway for a new product to enter the market, but also a mandate to pay high prices for an unproven therapy.”

The authors suggest three policy options to address the situation: 

- require manufacturers to offer additional price concessions to public insurance programs for drugs receiving accelerated approval until confirmatory trials are completed;
- encourage FDA to do more to ensure that confirmatory trials conducted after receiving accelerated approval are performed in a timely fashion and are designed optimally to limit the period of uncertainty about true clinical effect; and
- subject all drugs that move through the accelerated approval pathway and cost over $100,000 per year, or some other agreed-upon threshold, to formal economic analyses after 1-2 years on the market.

“In an era of constrained resources at both the state and federal levels, accelerated approval of expensive drugs leads to reduced resources available for other healthcare services that are already supported by strong clinical evidence,” the authors conclude. “We believe that changes to the accelerated approval process are required in order to ensure that it continues to benefit society.”