IPM: Key Facts in Alliance for Hippocratic Medicine v. FDA

TO: Interested Parties

FROM: ACLU, PPFA

DATE: March 24, 2023

RE: Key Facts in Alliance for Hippocratic Medicine v. FDA

The lengthy oral argument in Alliance for Hippocratic Medicine v. FDA that took place on Wednesday, March 15, continued the anti-abortion movement’s pattern of attacking reproductive health care through patently false and misleading claims. Unfortunately, despite the case lacking merit and any scientific credibility, Judge Matthew Kacsmaryk may accept some of the claims and try to block access to mifepristone when he issues his decision, expected imminently. 

Here’s what you need to know about the key legal arguments raised in the case by the plaintiffs, and why they should all be rejected:

CLAIM: Mifepristone is dangerous and should have never been approved. 

FACT: Since it was approved two decades ago, over 5 million people have safely and effectively used mifepristone to end a pregnancy. There is overwhelming evidence that medication abortion is safe and effective for virtually anyone who wants to end an early pregnancy, with a safety record of over 99%. Study after study confirms its safety, efficacy, and its critical role in abortion and miscarriage care. 

CLAIM: Pregnancy is not a disease, and therefore mifepristone should not have been considered for “accelerated approval” under the FDAs Subpart H authority. 

FACT: The FDA has stated that its approval of mifepristone was an appropriate use of Subpart H: “Unwanted pregnancy falls within the scope of subpart H under § 314.500 because unwanted pregnancy, like a number of illnesses or conditions, can be serious for certain populations or under certain circumstances,” and “medical abortion through the use of Mifeprex provides a meaningful therapeutic benefit to some patients over surgical abortion.” 

Pregnancy is indisputably a medical condition – one that can be serious and life-threatening. In fact, carrying a pregnancy to term carries far greater risk — 14 times greater — than an early abortion. Further, mifepristone was NOT approved on an accelerated basis under this regulation – it took the FDA four years for mifepristone to be approved in 2000. And in other countries, mifepristone has been approved and safely used since the 1980s. In 2008, the Government Accountability Office (GAO) examined FDA’s approval and oversight of mifepristone and rejected the very claims plaintiffs raise here. The GAO concluded in its report that the agency properly used its Subpart H authority to impose dispensing restrictions and did not use Subpart H to accelerate the drug’s approval.

CLAIM: Doctors with the Alliance for Hippocratic Medicine and other plaintiffs have “standing” to bring this case because mifepristone has harmed their practice.

FACT: Anti-abortion providers should not be able to bring this case because they have no injury  from mifepristone’s approval more than two decades ago and they cannot satisfy binding standing precedent. They claim that if patients take mifepristone to end their pregnancies, plaintiffs won’t have as many pregnant patients to treat — an egregious claim that puts their bottom line ahead of patient well-being and safety. They also argue that they are “harmed” because they sometimes have to treat people who have side effects from taking mifepristone – another ridiculous claim given that all doctors treat people who have side effects from medication. As the government has correctly argued, if these plaintiffs are allowed to bring this challenge on this basis, then virtually any doctor could challenge any FDA action, no matter how impacted they are from the action. That’s not how the law works. 

CLAIM: The 1873 Comstock laws make it a federal crime to send or receive drugs used for abortion care and should have prevented FDA from approving mifepristone. 

FACT: The Comstock laws are inapplicable with respect to legal abortion, as the DOJ’s Office of Legal Counsel recently confirmed. Furthermore, the Comstock laws’ restrictions on mailing certain items have no bearing on the FDA’s approval process for safe and effective medications, so this claim should not be considered at all in this case. Indeed, these claims are not even properly before the court, since plaintiffs never raised these arguments in their petitions to the FDA.  

CLAIM: FDA violated federal law by failing to consider the effect of mifepristone on adolescents.

FACT: Plaintiffs did not even raise this argument in their briefs, and, in any event, it is false. The FDA has evaluated this issue and has expressly concluded that medication abortion appears to be as safe, if not safer, in adolescents as in adult women.

CLAIM: Plaintiffs need the court to grant emergency relief to maintain the status quo.

FACT: To the contrary, an injunction granting the requested relief would upend the decades-long status quo and impose devastating harm on patients, health care providers, and businesses. It would disrupt the health care system and interfere with the longstanding gold-standard drug approval process with which Congress entrusted the FDA. 

CLAIM: Relief is required to protect the police powers of half the states in the country.

FACT: This claim distorts reality, as it is plaintiffs who are seeking a national policy, banning a drug that has been safely and effectively used by millions over two decades – prohibiting its use in every state across the country, including those with extensive protections for access to the full range of reproductive health care.