Because No One is Immune to the Law
January 27, 2022 - FDA, Biotech, Healthcare, Pharma

FDA OKs Mail-Order Mifepristone: State Laws May Inhibit its Use

Is 2021 the Value-Based and Shared Savings Revolution?

In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and through telemedicine in order to reduce the burden on patient access.  This policy change will be effected by the drug’s manufacturers making modifications to their Risk Evaluation and Mitigation Strategy (REMS), a program to restrict distribution of drugs that, in FDA’s judgment, is necessary for the safe and effective administration of such drugs.  The FDA announcement stated that it had ordered the drug’s manufacturers to modify their shared-system REMS to remove the requirement that mifepristone be dispensed only in certain certified in-person healthcare settings and allow for certified pharmacies to dispense the drug.  While the FDA’s announcement was met with much breathless commentary by proponents and opponents of the new policy, implementation is most likely at least a year away, and conflicts with many state laws may preserve the status quo until resolved by a court, effectively preventing mail order delivery of the drug or telemedicine prescribing of the drug in states that currently prohibit such practices.

Although many other drugs approved by FDA are subject to REMS, mifepristone is the only drug that FDA requires in-person dispensing.  FDA approved MIFEPREX (mifepristone) for early nonsurgical abortion in 2000, before amendments to the Federal Food, Drug, and Cosmetic Act authorized REMS designation.  Yet, FDA tightly regulated distribution of the drug, requiring in-person administration of mifepristone at a health care facility by a specially trained physician with an in-person signature requirement.  With the accumulation of scientific evidence of the drug’s safety over time, including its use since the 1980s in Europe, FDA and the manufacturers of mifepristone have gradually made changes to the REMS to reduce barriers to access, including prescribing by non-physicians, allowing patients to take the medication at home, and extending the gestational period during which the medication is approved for use from seven weeks to ten weeks.  The COVID-19 pandemic, which has placed unprecedented burdens on the health care system and made in-person appointments more risky for patients and providers, likely created the conditions for a change in the in-person dispensing and signature policy at the federal level.  The American College of Obstetricians and Gynecologists and others sued FDA to eliminate these in-person requirements during the public health emergency and were successful in the trial court.  FDA’s announcement mooted the case on appeal.

As of June 16, 2021, at least nineteen (19) states prohibited telemedicine abortion, either expressly or impliedly, by requiring the prescribing clinician to be physically present with the patient.[1]  Moreover, there are also twenty-six (26) states that require patients to receive an ultrasound before an abortion and another twelve (12) that have in-person counseling requirements.[2]  In other words, the option for a telehealth protocol for medication abortion  is currently available in only 22 states and DC.  This acutely demonstrates the conflict that can arise between the traditional domain of the states with respect to regulation of the healthcare professions (including medicine and pharmacy) and the execution of federal health care policies. 

Some argue that REMS should preempt the state laws  in this particular situation because FDA’s modification to the REMS for mifepristone considered factors that place the state laws in direct contradiction.  Others argue that the REMS would not preempt more stringent state laws that would prohibit a provider from prescribing the drug via a telemedicine setting.  Another potential outcome is that a court could allow an alternative approach, such as allowing states to impose telemedicine restrictions but preempting state restrictions on distribution of the medication (e.g. via the mail) or declaring such restrictions a burden on interstate commerce.  A compromise along those lines would mean that the need for an in-person visit would hinder initial access for rural populations; however, a patient’s local pharmacy could then dispense the medication or a mail-order pharmacy could deliver the medication to a patient’s home.

Although the consumer uptake of telemedicine continues to increase at a rapid pace during the public health emergency, it remains to be seen whether the modification of the REMS for mifepristone will result in wider access to the drug through telemedicine.  Setting aside the deep rifts in public opinion on the issue of abortion, another likely reason that companies have yet to undertake offering mail order mifepristone is likely due to the national scope of their businesses.  State-by-state regulatory hurdles, which require different processes and procedures, create operational hurdles that are time consuming and burdensome to overcome.  Without federal legislation legalizing the use of telemedicine to prescribe mifepristone, or a court decision that clarifies the roles of the states and federal government respectively, the nationwide patchwork of requirements will likely remain barriers to businesses who would otherwise enter this market.

[1] Kaiser Family Foundation, Medication Abortion and Telemedicine: Innovations and Barriers During the COVID-19 Emergency (June 16, 2021),

[2] Id.