Navigating Abortion Restrictions Post Dobbs: Considerations for Pharmacy Providers
As a result of the United States Supreme Court’s June 24, 2022 ruling in Dobbs v. Jackson Women’s Health Organization overturning Roe v. Wade and Planned Parenthood v. Casey, and eliminating a constitutional right to abortion, pharmacy providers are looking to state laws and other recently issued federal guidance in determining how they can meet patient needs and deliver medications in compliance with applicable laws.
Pharmacy challenges: mifepristone and misoprostol
Mail order pharmacies that ship medications across all 50 states are having to get up to speed on resident and non-resident pharmacy requirements related to certain medications. Two such drugs are mifepristone and misoprostol, a two-drug protocol that first blocks progesterone, a hormone necessary for pregnancy, and then 24 to 48 hours later, helps to empty the uterus. These drugs, however, may be prescribed for other clinical situations other than abortion, which create challenges for pharmacists attempting to navigate the new, and often vague, abortion restrictions.
The US Food and Drug Administration (FDA) approved mifepristone over 20 years ago in 2000,1and over time has removed some restrictions. However, the medication remains under a risk evaluation and mitigation strategy (REMS), which FDA may require for certain medications “with serious safety concerns to help ensure the benefits of the medication outweigh its risks.”2 Although questions have been raised as to whether mifepristone should still be subject to a REMS, to date, FDA has given no indication that the REMS for this drug will be significantly modified or removed.
In December 2021, FDA removed an in-person requirement from the REMS, following a relaxation in this requirement due to the COVID-19 public health emergency, and the medication can now be prescribed via telehealth. While there is no longer an in-person requirement under the REMS, FDA did include an additional requirement: Pharmacies that dispense mifepristone must be certified. This certification is to be done by the manufacturers of the medication, and to date an FDA-approved certification process has not been implemented. Therefore, even though the FDA pre-Dobbs, moved to relax the prescribing of mifepristone, as a practical matter, the REMS requirement of certification for pharmacies restricts mail order pharmacies’ ability to deliver medications.
After the Dobbs decision was released, Attorney General Merrick Garland reiterated that FDA has already approved the use of mifepristone, and stated that “States may not ban mifepristone based on disagreement with FDA’s expert judgment about its safety and efficacy.”3 However, while FDA relaxed the in-person requirement, this still remains a permissible requirement when these drugs are provided for purposes of causing an abortion in several states, in contravention of the federal law. Some states, such as Illinois, have established a fundamental right to make autonomous decisions about one’s own reproductive health, including the right to have an abortion,4 though its neighboring states have additional barriers in place.
For example, Wisconsin allows for the use of abortion inducing drugs, though requires the physician to perform a physician exam and be physically present in the room when the drug is given.5 In addition to an in-person requirement, Indiana prohibits the use of abortion inducing drugs after “eight (8) weeks of postfertilization age”.6 It is also important to note that virtually all abortion restrictions have some form of “intent” element, which suggests that prescribing and dispensing these drugs may still be permissible when dispensed for purposes other than causing an abortion. For example, Wisconsin defines an “abortion-inducing drug" as a drug, medicine, oral hormonal compound, mixture, or preparation, when it is prescribed to terminate the pregnancy of a woman known to be pregnant.7
In another post-Dobbs development, the US Department of Health and Human Services (HHS) issued guidance on July 13, 2022, to pharmacies and pharmacists, related to the nondiscrimination obligations of pharmacies under the federal civil rights laws.8 For example, under Section 1557 of the Affordable Care Act and its implementing regulation, a pharmacy provider that receives federal funds (e.g., Medicare and Medicaid reimbursement), is prohibited from discriminating against individuals on the basis of sex.9
Other federal laws prohibit discrimination on the basis of disability. Discrimination against pregnant women on the basis of their pregnancy or related conditions is a form of sex discrimination. This discrimination extends to current, past, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth. HHS points out that while pregnancy itself is not a disability, medical issues resulting from it may qualify as a disability and are also protected.
The HHS guidance provides several examples of situations where a pharmacy may be discriminating based on sex or disability if a pharmacist does not fill prescriptions, including refusing to fill mifepristone and/or misoprostol.
GenBioPro v. Dobbs
Mail order pharmacy providers should take note of the lawsuit filed by GenBioPro, the manufacturer of the generic form of mifepristone in the Southern District of Mississippi, Genbiopro, Inc. v. Dobbs, S.D. Miss., No. 3:20-cv-00652. GenBioPro makes arguments under both the Supremacy Clause and Commerce Clause of the US Constitution that (a) federal law, in this case, the FDA approval of mifepristone preempts any contrary state laws (such as e.g., the Wisconsin and Indiana examples cited above, or more restrictive states such as Mississippi the subject of the GenBrioPro litigation which prohibits abortions using “any instrument, medicine, drug or any other substance or device to terminate the pregnancy of a woman known to be pregnant”)10 and (b) the states cannot interfere with interstate commerce. Mississippi, for its part, generally takes the position that it is only restricting these drugs for the purposes of causing an abortion, which is within its legal authority.
Mississippi’s briefings do not address situations where the drug is dispensed for another purpose or whether the simple possession of a drug (e.g., at a wholesaler warehouse) constitutes some violation of the state abortion restriction. A ruling by a court that allows states to outright ban, or restrict mifepristone could have other unintended consequences to other FDA-approved drugs, such as another drug referenced in the HHS guidance, methotrexate, which is a standard immunosuppressive treatment but has an alternative use to induce abortions.
The Commerce Clause argument advanced in the GenBrioPro case could also be used to challenge state laws that interfere with the ability of pharmacies to deliver these medications across state lines through the US Mail or by common carrier. Under the Commerce Clause, states are limited in their authority to enact laws which impose an undue burden on interstate commerce. The Dormant Commerce Clause prohibits states from regulating in a manner that would discriminate against or unduly burden interstate commerce and would thereby impede free trade in the national marketplace. Arguably, just as states should not be permitted to prohibit their citizens from traveling across state lines to obtain pharmacy services that are not available in their state, the Dormant Commerce Clause could be used to challenge laws that prohibit a patient from accessing those pharmacy services through the mail.
Consistent with the Mississippi position that it is only restricting drugs for the purposes of causing an abortion, a new Louisiana law, effective August 1, 2022, restricts provision of “abortion-inducing drugs”, including specifically the Mifeprex regimen (the brand name for mifepristone), misoprostol, or methotrexate, when “knowingly” provided to induce an abortion, but does seem to acknowledge that there may be other uses for the medications. Exceptions under the Louisiana law include acts by a licensed pharmacy or pharmacy related to filling a prescription for a drug for a “bona fide medical reason,” provided the diagnosis code is included on the prescription indicating that the purpose is other than to cause an abortion.11
Mail order pharmacy providers that do business in several states need to consider both the federal and state laws and guidance in how they approach the dispensing of these drugs. The GenBioPro case highlights some of the risks that pharmacies are trying to manage, including an obligation not to discriminate against certain classes of people and to fill prescriptions for a drug that is approved by the federal government with certain conflicting state restrictions.
Jaya White is Chicago office chair of the Health Law Practice Group; Edward Rickert is a partner; and Richard Davis is an associate, all at the law firm, Quarles & Brady LLP.
References
1. US Food And Drug Administration, Mifeprex (Mifepristone) information.https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information
2. US Food And Drug Administration, Risk Evaluation And Mitigation Strategies.
3. US Dep’t of Justice, Attorney General Merrick B. Garland Statement on Supreme Court Ruling in Dobbs v. Jackson Women’s Health Organization (2022).
4. 775 Ill. Comp. Stat. Ann. 55/1-15.
5. Wis. Stat. Ann. § 253.105(2).
6. Ind. Code Ann. § 16-34-2-1(a)(1). On 8/5/2022, Indiana enacted Public Law 179(ss) which effectively bans abortions unless the pregnant person’s serious health or life is at risk OR if there’s a lethal fetal anomaly up to 20 weeks post-fertilization OR and in cases of rape or incest, but only up to 10 weeks post-fertilization. The majority of the new restrictions take effect on 9/15/2022.
7. Wis. Stat. Ann. § 253.10 (2)(am).
8. US Dep't Of Health & Human Services, Office For Civil Rights, Guidance to Nation’s Retail Pharmacies: Obligations Under Federal Civil Rights Laws to Ensure Access to Comprehensive Reproductive Health Care Services (2022).
9. 42 U.S.C. § 18116; 45 C.F.R. § 92 et seq.
10. Miss. Code. Ann. § 41-41-45.
11. La. Stat. Ann. § 14:87.9.