No, Judge Matthew Kacsmaryk, mifepristone did not undergo 'accelerated approval.'
government lawyers to defend the FDA’s “accelerated approval” of mifepristone nearly 23 years ago. In doing so, he implied that the agency’s allegedly rushed decision might justify pulling the drug from the market today.This entire argument is built upon a lie. The FDA did not fast-track mifepristone in 2000. Rather, the agency took more than four years to greenlight the drug, doing so only after extensive examination of its risks.
In 1996, mifepristone’s “sponsor,” an organization called the Population Council, submitted an application for the drug to the FDA. The agency spent the next four years soliciting voluminous amounts of data, including multiple clinic studies, from the sponsor. Eventually, Population Council’s data persuaded the FDA that mifepristone was both safe and effective enough for use through 49 days’ gestation.
true that Subpart H only existed to expedite review. This regulation had another purpose: It allowed the FDA to approve a new drug conditionally, set up extra roadblocks around its use, and monitor its impact to ensure safety and efficacy. Indeed, when the agency proposed Subpart H in 1992, some commentators urged it to call the regulation “conditional approval” instead of “accelerated approval,” as the later term wrongly suggests that all drugs greenlit under Subpart H were fast-tracked.
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