Anti-abortion advocates take aim at FDA approval and regulation of the abortion drug mifepristone, threatening access nationwide.
The U.S. Food and Drug Administration (FDA) should have the final say on what drugs are safe and effective for use in their prescribed populations—not states, not courts, and certainly not the Alliance for Hippocratic Medicine (AHM).
The organization, a consortium of medical advocacy groups gathered to challenge FDA, filed its final brief in a Alliance for Hippocratic Medicine v. FDA in a federal trial court in Texas earlier this week. The group argues that the FDA’s approval of the medical abortion drug mifepristone lacks authority, harms women and their doctors, and must be withdrawn.
This case is one of many to come in the aftermath of the Dobbs v Jackson Women’s Health decision, which gave states the power to regulate any aspect of abortion not regulated by federal law.
If AHM prevails, mifepristone, one of two drugs that taken together account for over half of U.S. abortions, may be pulled from the market. With millions of women relying on the dual drug regimen for abortion access in the post-Dobbs world, such a misguided decision would cause short-term chaos and set a dangerous long-term precedent.
Mifepristone works by blocking the hormone progesterone, which supports the pregnancy. Once mifepristone is used to pause the pregnancy, it is typically followed by misoprostol, which simulates contractions and expels the embryo from the uterus. If AHM succeeds on its claim, misoprostol can be used alone for medical abortions. Health care practitioners warn, however, that misoprostol in isolation may be less effective while causing more severe side effects, such as pain, bleeding and nausea.
AHM’s main claim is that FDA’s initial approval of the abortion drug was defective, because the agency relied on a regulatory provision known as Subpart H addressing the accelerated approval of drugs “for serious or life-threatening illnesses.” The organization argues that because pregnancy is not an illness, but a “normal physiological state,” the agency’s initial approval of the drug and all subsequent controls over its distribution lacked authority.
In reality, FDA explains that the four-year approval process for mifepristone was far from “accelerated.” Scholars also note that FDA has a history of using the terms “illness” and “condition” interchangeably. Both the preamble of FDA’s Subpart H regulation as well as Congress’s codification of Subpart H in the FDA Modernization Act of 1997 demonstrate this trend.
Moreover, Subpart H was used to enhance the drug’s safety as the section provides a mechanism for placing additional restrictions on the drug’s use. When the FDA Amendments Act of 2007 established the Risk Evaluation and Mitigation Strategy (REMS) program for drugs that required special restrictions, FDA made mifepristone one of the first drugs regulated by REMS.
Although AHM contends that FDA has not addressed patient safety concerns expressed in repeated citizens petitions, scholars have chronicled the long history of FDA’s comprehensive, science-based regulation of the drug.
In fact, scholars highlight that the Government Accountability Office (GAO) has twice reviewed FDA’s approval and controls of mifepristone. In 2008, in response to calls from anti-abortion members of Congress, GAO published a 43-page report in which it determined that mifepristone’s approval was consistent with that of other Subpart H drugs. GAO also said that the drug’s approval was supported by FDA’s comprehensive evaluation of clinical studies and other substantial medical and scientific data.
In 2018, GAO published yet another report reviewing FDA’s changes to mifepristone’s REMS. After conducting an independent review of the clinical data supporting those changes, GAO found that the agency’s decision was supported by “numerous studies” of tens of thousands of women.
FDA has continued to adjust the REMS restrictions in response to additional data. In 2021, the agency evaluated clinical and scientific information generated during the COVID-19 public health emergency and determined that removing the in-person dispensing requirement would reduce the burden on doctors and patients while maintaining the drug’s risk to benefit ratio. In January 2023, the REMS webpage for mifepristone was updated to allow distribution via mail and retail pharmacies with prior certification.
As part of a strategy to ensure continued access to the drug, twelve attorneys general have filed a lawsuit in a Washington State federal court on February 24, 2023 claiming that even those reduced REMS requirements should be eliminated to expand access to the drug. The complaint also requests that the court declare FDA’s approval of the drug lawful and valid and prevent FDA from “from taking any action to remove mifepristone from the market or reduce its availability.”
That same afternoon, Vice President Kamala Harris convened a team of doctors and abortion rights advocates to generate a plan for continued access. Harris condemned attempts to “question the legitimacy of a group of scientists and doctors who have studied the significance of this drug.”
AHM’s case is not the first time, however, that such legal attacks in Texas courts have attempted to disempower scientific decision-making. Another federal case pending final disposition, Braidwood Management v Becerra, entertained Appointments Clause and nondelegation arguments to strip federal entities such as the U.S. Preventative Services Task Force of the authority to make evidence-based recommendations for mandatory insurance coverage under the Affordable Care Act.
When courts are asked to second-guess FDA directly, however, scholars contend that U.S. Supreme Court precedent supports preemption of state drug laws by federal regulations. Even conservative justices on the Court have advocated broader FDA preemption. In a 2009 dissenting opinion joined by Chief Justice John Roberts and Justice Antonin Scalia, Justice Samuel Alito noted that “where FDA determines, in accordance with its statutory mandate, that a drug is on balance ‘safe,’ our conflict preemption cases prohibit any state from countermanding that determination.”
FDA preemption jurisprudence will be put to the test soon in another courtroom showdown in West Virginia, where GenBioPro, the generic manufacturer of mifepristone, has filed a suit challenging the state’s ban of the drug. Although victory for the manufacturer could override state restrictions on the drug, scholars warn that if West Virginia prevails such precedent could lead to state bans of other FDA approved drugs or COVID-19 vaccines.
The post-Dobbs battleground for abortion access is sprawling and uneven, but patient health and access must prevail. FDA’s decisions, rooted in scientific and medical principles, supported by years of clinical data and experience, certified by Congress’s watchdog, and trusted by health care professionals and the women they serve throughout the nation, should not be second-guessed and overridden by a single judge, in a single state.