When FDA and the Practice of (Tele)Medicine CollideOctober 24, 2019
It is generally accepted that FDA’s authority under the Federal Food, Drug, and Cosmetic Act (FDCA) does not allow for FDA to regulate the practice of medicine. FDCA § 1006 (21 U.S.C. § 396) explicitly states that FDA may not interfere with the practice of medicine related to legally marketed medical devices. However, when it comes to the practice of medicine related to prescription drugs, this line is not always bright. A complaint filed in September in the District Court for the District of Idaho by Rebecca Gomperts, a European physician, and Aid Access, a website designed to “serve women with unwanted first trimester pregnancies globally”, draws new attention to FDA’s role in regulating access to prescription medications and how FDA’s authority may intersect with the practice of medicine. Gomperts v. Azar et al., 1:19-cv-003450DCN (D. Idaho Sept. 9, 2019). At the outset, we note that this case is centered on two potentially divisive issues – telemedicine and medical abortion.
As discussed in our article, in March 2019, Aid Access received a Warning Letter from FDA alleging that Aid Access violated the FDCA by introducing misbranded and unapproved new drugs into interstate commerce. This lawsuit appears to be a direct consequence of that Warning Letter.
Before discussing the allegations in the complaint, it is helpful to understand the regulatory background of the drugs used for medical abortion. Mifeprex (mifepristone) is used with misoprostol to end an early pregnancy. FDA approved Mifeprex in September 2000 with a REMS program that includes an Element to Assure Safe Use (ETASU). The ETASU allows only specially certified prescribers that have completed a Prescriber’s Agreement to prescribe Mifeprex. In order to prescribe Mifeprex to a patient, a certified prescriber must have:
- the ability to date a pregnancy and diagnose an ectopic pregnancy,
- made plans for the patient to receive surgical abortion care in cases of incomplete abortion or severe bleeding, and
- ensured that the patient has access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
The certified prescriber must also agree to provide the patient with the Medication Guide and a Patient Agreement, discuss the Patient Agreement with the patient, have the patient sign the Patient Agreement, and counter-sign the Patient Agreement. Mifeprex may only be dispensed in certain health care settings, specifically clinics, medical offices, and hospitals, by and under the supervision of a certified prescriber. Mifeprex may not be distributed or dispensed through retail pharmacies.
According to the complaint, the REMS and ETASU imposed by FDA pose an undue burden on the rights of U.S. women to terminate unwanted pregnancies during the early stages. Because of the high cost of in-clinic abortion services and the limited availability of misoprostol and mifepristone in the U.S., the complaint argues that many women in the U.S. are forced to use the internet to obtain the medications necessary to end their unwanted pregnancies. The complaint alleges that women who live in rural or medically underserved areas, have low income, are experiencing domestic abuse and/or are young, are the most impacted by the restrictions imposed by FDA. The complaint characterizes FDA’s restrictions on these drugs as “actively using the power of the US government to deny Plaintiffs’ patients their constitutionally protected right to terminate their unwanted pregnancies.”
Dr. Gomperts founded Aid Access in 2018; she uses the website to serve women with unwanted first trimester pregnancies by prescribing misoprostol and mifepristone after a telemedicine consultation. The complaint explains that, between March 30, 2018 and August 27, 2019, over 37,000 women in the U.S., spanning all fifty states and the District of Columbia, contacted Aid Access. Dr. Gomperts prescribed misoprostol and mifepristone to 7,131 of these women. According to the complaint, Dr. Gomperts only prescribes the drugs to women in the U.S. if, in her professional judgment as a licensed physician, she believes that the woman can safely have a medical abortion.
Since the REMS specifically state that these drugs may not be distributed or dispensed through retail pharmacies, Dr. Gomperts provides her patients with instructions for how to get the misoprostol and mifepristone delivered to them in the U.S. Patients are directed to send their prescriptions to a merchant exporter of prescription medications in India. The exporter sends the prescription medications from India directly to the U.S. patients with customs declarations describing the contents of the packages as “Personal Supply of Rx Medicines.” Notwithstanding this apparently accurate description, the complaint alleges that FDA, through U.S. Customs and Border Patrol and the U.S. Postal Service, has seized between three and ten individual doses of misoprostol and mifepristone prescribed and exported to individuals in the U.S.
The complaint alleges that FDA is violating Dr. Gomperts’ patients’ substantive due process rights to liberty and privacy. The complaint includes a number of allegations that the FDA is violating Dr. Gomperts’ and her patients’ right to equal protection under the Fifth Amendment by treating Dr. Gomperts and her patients differently from other similarly situated parties without a sufficient state interest. The complaint also includes several claims under the Administrative Procedure Act, such as FDA is acting in excess of its statutory authority under the FDCA, and that FDA’s treatment of these drugs is arbitrary, capricious and an abuse of discretion.
FDA has not yet filed a response to this complaint, but we expect that the Agency will fight to preserve its authority to regulate access to these prescription medications under the FDCA. As mentioned above, although the practice of medicine is generally outside of FDA’s statutory purview, this case presents facts that may tip the balance in FDA’s favor. For example, Dr. Gomperts is not licensed to practice medicine in the U.S. FDA typically avoids issues related to the practice of medicine because the regulation of the practice of medicine has been delegated to the states. Each state sets its own licensure requirements and the individual state Boards of Medicine enforce compliance with those state laws. Here, however, where multiple states are implicated, it may be that FDA is an appropriate agency to regulate the practice of medicine for these particular products.
FDA’s statutory authority does allow the Agency to regulate medications that are in the stream of commerce. As already asserted in its Warning Letter to Aid Access, FDA will likely argue that Dr. Gomperts has violated the FDCA by causing the introduction of an unapproved and misbranded drugs, since the misoprostol and mifepristone prescribed by Dr. Gomperts and shipped directly to the patients from India is not in compliance with the REMS provisions for these drugs. We note that FDA’s website includes numerous warnings that patients should not buy Mifeprex or mifepristone over the internet because doing so “will bypass important safeguards designed to protect your health.”
We will continue to monitor this case and other developments related to FDA and the use of telemedicine.