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The Legal Argument for Banning the Abortion Pill Is Based on a Lie
SlateNo paywall
At Wednesday’s hearing over the fate of mifepristone, conservative lawyers repeatedly insisted that the FDA wrongly greenlighted the abortion medication in 2000 through an “accelerated approval” process. Judge Matthew Kacsmaryk—the far-right Trump nominee whom the plaintiffs hand-picked to oversee the case—evidently agreed: According to reports from the courtroom in Amarillo, Texas, Kacsmaryk continually pressed 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 (and arguably superfluous) examination of its (very minor) risks. When the FDA did finally approve the use of mifepristone, after an unusually thorough review, however, it imposed heightened restrictions on its distribution. It was these extra barriers to mifepristone access that were set up through a process known as accelerated approval. The plaintiffs here exploit confusion about these procedural details to peddle the false narrative that the agency recklessly hastened review of mifepristone. It is an extremely ominous sign that Kacsmaryk appeared to agree with their false history.
These plaintiffs, a group of anti-abortion doctors represented by Alliance Defending Freedom, did not have to work very hard to devise this story: A great deal of media coverage, and even some medical literature, states in passing that mifepristone received accelerated approval because it was ultimately greenlighted under an FDA regulation called Subpart H. The confusion arises from a misunderstanding about how, exactly, the FDA relied on this regulation back in 2000. It is worth recounting the actual events that led up to that point.
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 clinical studies, from the sponsor. (Ironically, you can find all this information in a 505-page appendix submitted by Alliance Defending Freedom, much of which contradicts the group’s own legal and factual claims.) Eventually, Population Council’s data convinced the FDA that mifepristone was both safe and effective enough for use through 49 days’ gestation. After completing review of all data, including clinical trials, the FDA issued an approval letter in the ordinary manner. In keeping with its ultra-cautious approach to the drug, though, the agency decided to continue studying the drug post-approval and to enact additional burdens on its distribution. Only then was Subpart H invoked—at the time, federal law allowed the FDA to impose these rules through Subpart H.
It is true that Subpart H regulations are commonly referred to as “accelerated approval.” It is also true that the FDA often used this process to fast-track drugs for HIV, cancer, and other lethal conditions in desperate need of new treatments. But it is not true that Subpart H existed only to expedite review.
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 (and arguably superfluous) examination of its (very minor) risks. When the FDA did finally approve the use of mifepristone, after an unusually thorough review, however, it imposed heightened restrictions on its distribution. It was these extra barriers to mifepristone access that were set up through a process known as accelerated approval. The plaintiffs here exploit confusion about these procedural details to peddle the false narrative that the agency recklessly hastened review of mifepristone. It is an extremely ominous sign that Kacsmaryk appeared to agree with their false history.
These plaintiffs, a group of anti-abortion doctors represented by Alliance Defending Freedom, did not have to work very hard to devise this story: A great deal of media coverage, and even some medical literature, states in passing that mifepristone received accelerated approval because it was ultimately greenlighted under an FDA regulation called Subpart H. The confusion arises from a misunderstanding about how, exactly, the FDA relied on this regulation back in 2000. It is worth recounting the actual events that led up to that point.
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 clinical studies, from the sponsor. (Ironically, you can find all this information in a 505-page appendix submitted by Alliance Defending Freedom, much of which contradicts the group’s own legal and factual claims.) Eventually, Population Council’s data convinced the FDA that mifepristone was both safe and effective enough for use through 49 days’ gestation. After completing review of all data, including clinical trials, the FDA issued an approval letter in the ordinary manner. In keeping with its ultra-cautious approach to the drug, though, the agency decided to continue studying the drug post-approval and to enact additional burdens on its distribution. Only then was Subpart H invoked—at the time, federal law allowed the FDA to impose these rules through Subpart H.
It is true that Subpart H regulations are commonly referred to as “accelerated approval.” It is also true that the FDA often used this process to fast-track drugs for HIV, cancer, and other lethal conditions in desperate need of new treatments. But it is not true that Subpart H existed only to expedite review.
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