MedCity Influencers, Legal

Challenging State Abortion Bans in Light of FDA’s Rule Change on the Sale of Abortion Pills

The current legal landscape makes access to medication abortion crucial in protecting as much access to reproductive healthcare as possible and in protecting healthcare providers’ abilities to do their jobs without fear of prosecution. 

In June, the United States Supreme Court abandoned nearly 50 years of precedent and, for the first time in this nation’s history, eliminated a fundamental right: the right to choose.  This decision, Dobbs v. Jackson Women’s Health Organization, overruled the landmark case, Roe v. Wade, and triggered changes in abortion laws around the country. Many states immediately eliminated access.

The Supreme Court’s decision also eliminated women’s ability to challenge state laws restricting or banning abortion care as violating their federal, constitutional rights.  In states with restricted or eliminated access, healthcare providers have bene unable to deliver the standard of care to pregnant women, in part, because they cannot decipher what kinds of healthcare are permitted under these laws and when.  For example, healthcare providers are often unable to determine how sick a woman must be to qualify for the life-of-the-mother exceptions in many of these abortion bans—for example, it’s unclear how much blood a hemorrhaging woman must lose before abortion care can be provided or how sick a woman suffering through a miscarriage must be before miscarriage care can be provided.  Moreover, for many of the laws using a standard based on medical judgment, medical providers are afraid to provide care at all as these new, draconian laws leave providers with little room for mistakes or misunderstandings.  The confusion has resulted in pregnant women being denied crucial healthcare in emergency situations because a healthcare provider feared prosecution.

The current legal landscape makes access to medication abortion crucial in protecting as much access to reproductive healthcare as possible and in protecting healthcare providers’ abilities to do their jobs without fear of prosecution.  Mifepristone—the “abortion pill” that can be prescribed for a pregnancy up to ten weeks—is currently the most common method for terminating a pregnancy, accounting for more than half of all U.S. abortions.  Access to this medication allows pregnant women to access abortion care without having to undergo any procedure in person and, crucially, has provided limited access to healthcare for women in states with strict abortion bans who obtain the medication through the mail.

Recently, the FDA enacted rules allowing pharmacies to dispense mifepristone directly to patients, foregoing the previous requirement that a doctor dispense it directly.  This rule change unlocks a huge potential market share for pharmacies.  Prior to Dobbs, an estimated 4.9 million pregnant women used mifepristone in the U.S. to terminate a pregnancy from its initial approval through the end of June 2021.  All accounts expect this number to skyrocket in the face of diminished and eliminated access to reproductive healthcare following Dobbs.

But in states where abortion is either fully banned or banned at some point before 10 weeks, pharmacies won’t be able to dispense the drug.  Criminal state-law abortion bans typically cover providing medication with the intent of terminating a pregnancy, making a pharmacy’s dispensing of mifepristone to pregnant women a crime in those states.  And pregnant women in those states won’t be able to benefit from the FDA’s new rule at all, despite that rule being based on data about the pill’s safety and effectiveness.

The FDA’s rule was intended to expand access, yet these laws subvert that intent.  Private pharmacies, however, are uniquely and powerfully poised to challenge these laws in order to simultaneously protect market share and access to healthcare.  For example, pharmacies could bring challenges in federal court to bans on the distribution of FDA-approved abortion pills based on the Supremacy Clause and preemption of state law.

A successful challenge would be lauded for numerous reasons.  First, access to mifepristone is widely supported by Americans, with more than half of Americans specifically supporting access to medication abortion and 67% of Americans supporting access to abortion generally in the first trimester of pregnancy—the only period for which mifepristone is FDA approved.  Second, as more states restrict abortion, easy access to medication abortion is more critical to reproductive health than ever.  A successful challenge would preserve critical healthcare to immeasurable pregnant women living in states that have been chipping away at their rights over the last several years.  It is these states where demand for medication abortion will be highest, and thus where a preemption challenge is most critical.  Finally, given how many abortions in America occur by medication abortion, a preemption challenge would also preserve some of the economic value in allowing pharmacies to dispense mifepristone in states where demand is highest.

Pursuant to the Supremacy Clause, state law that conflicts with federal law is without effect.  State law and federal law can “conflict” in various ways.  First, under a form of preemption called “obstacle preemption” theory, state and federal law conflict if state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Hines v. Davidowitz, 312 U.S. 52, 67 (1941).  Under obstacle preemption, bans on dispensing mifepristone arguably conflict with the Federal Food, Drug, and Cosmetic Act (“FDCA”).  The FDCA created the FDA and charged it with “promot[ing] the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.” 21 U.S.C. § 393(b)(1). Congress required the FDA to “protect the public health” by making sure that “drugs are safe and effective,” and granted it the authority to assess the benefits and risks of various drugs.  Id. § 393(b)(2)(B).  Here, the FDA has approved mifepristone subject to a Risk Evaluation and Mitigation Strategy (“REMS”), a safety program explicitly meant to ensure that the drug’s benefits outweigh its risks.

State abortion bans plainly stand as an obstacle to accomplishing the FDCA’s goals.  These bans prohibit access to medications specifically approved by the FDA, despite the FDA’s determination that they are safe and effective and that their benefits outweigh their risks subject to the REMS.

Second, under an “impossibility preemption” theory, state law is preempted by federal law “where compliance with both federal and state regulations is a physical impossibility for one engaged in interstate commerce.”  Fla. Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142–43 (1963).  The Supreme Court has specifically rejected the argument that the option of choosing not to sell a drug in states with requirements that conflict with federal law makes it possible for the manufacturer to comply with both state and federal requirements.  Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472, 476 (2013). Thus, under this separate theory, FDA approval preempts state abortion bans because the only way a manufacturer could comply with a state ban on FDA-approved mifepristone would be to stop selling the drug in the state altogether.

These preemption theories stand a reasonable to strong chance of success and any pharmacy who brings them would enjoy the dual benefits of being a first mover and establishing itself as a leader in this evolving area of crucial healthcare.  Indeed, the Department of Justice has already signaled support for these preemption arguments, even signaling that it might bring a preemption challenge to state bans of mifepristone itself.  The FDA’s new rule gives pharmacies standing to bring this type of challenge, as well—these state bans now directly, economically harm pharmacies who would be able to get certified to dispense mifepristone but-for the bans that arguably violate the Supremacy Clause.  Pharmacies seeking certification to dispense mifepristone could therefore challenge any bans on it, arguing that those bans harm its economic interests, providing a new set of potential plaintiffs to enter the battle for reproductive freedoms.

Photo: Bet_Noire, Getty Images

Joanna Wright is a partner with Boies Schiller Flexner LLP in New York.

Sabina Mariella is an associate with Boies Schiller Flexner LLP in New York.

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