June 16, 2020
Rep. Pressley, Colleagues Lead More than 100 Members of Congress in Urging FDA to Ease Restrictions on Medication Abortion Drug
WASHINGTON – While the Trump administration has encouraged the use of telemedicine across the health care industry during the pandemic, it has refused to relax rules around medication abortion drugs, a move that experts warn may put both patients and providers at greater risk of contracting the coronavirus.
Today, Congresswomen Ayanna Pressley (D-MA), Chair of the Pro-Choice Caucus Abortion Rights & Access Task Force, Diana DeGette (D-CO), Barbara Lee (D-CA), and Jan Schakowsky (D-IL) led a group of 109 lawmakers in urging the Food and Drug Administration (FDA) to ease the dispensing restrictions on mifepristone – the first of two medications used in combination to safely and effectively induce an early abortion or treat an early miscarriage. While the pill has been used in the U.S. for more than 20 years, FDA has long subjected mifepristone, when used for early pregnancy termination, to a set of highly restrictive requirements, known as Risk Evaluation and Mitigation Strategies (REMS). These requirements make it unnecessarily difficult for patients to access care.
One of those policies – the “in-person dispensing requirement” – requires patients to make a potentially unnecessary trip to a hospital, clinic, or medical office just to pick up the mifepristone pill. Out of more than 20,000 FDA-approved drugs, mifepristone is the only drug that FDA requires to be dispensed only in clinical settings while permitting patients to self-administer it at home.
“The REMS in its current form creates an illogical situation in which a patient can meet with her doctor by telehealth from the safety of her home, take the pills at home, safely have her abortion at home, and follow up with her doctor after the abortion by telehealth again, but must first travel in the midst of a global pandemic just to pick up the pills from a registered facility or provider,” the lawmakers wrote to Food and Drug Administration Commissioner Stephen Hahn. “For many patients, this requirement can mean taking public transportation, riding in someone else’s car, or traveling hundreds of miles away from home to another county or state — significantly increasing their risk of exposure to the virus. It also means that some providers and clinic staff are forced to have unnecessary in-person interactions that increase their own exposure risks.”
The United Kingdom has already issued guidance authorizing physicians to mail mifepristone to pregnant patients during the pandemic following a telephone or video consultation, and FDA itself has already suspended enforcement of other types of REMS restrictions necessitating in-person visits, noting that “patients may need to avoid public places and patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine.”
The lawmakers are urging FDA to take immediate action to allow certified prescribers to mail mifepristone to patients during the pandemic.
As Chair of the Abortion Rights and Access Task Force, Congresswoman Pressley has fought to protect