FDA pauses enforcement of in-person dispensing requirement for abortion pill


The FDA will pause enforcement of a rule requiring mifepristone be dispensed in person, citing the potential risk of COVID-19 exposure to patients and providers.

Mifepristone, which is used to end early pregnancies and for miscarriage management, can now be mailed to patients by certified prescribers.

Medical groups have long argued that the in-person dispensing requirement is unnecessary because the drug is safe. During COVID-19, the American College of Obstetricians and Gynecologists (ACOG) ramped up their efforts to have the requirements paused at least temporarily so patients would not have to risk exposure to the virus at the pharmacy, doctor’s office or public transportation.

“By halting enforcement of the in-person dispensing requirement during the COVID-19 pandemic, the FDA is recognizing and responding to the available evidence – which has clearly and definitively demonstrated that the in-person dispensing requirement for mifepristone is unnecessary and restrictive,” ACOG CEO Dr. Maureen Phipps said in a statement.

ACOG will continue to push for the policy to be permanently changed.

Earlier in the pandemic, after ACOG sued the previous administration, a federal judge ordered the FDA to pause enforcement of the policy, resulting in a six-month period where people could get mifepristone through the mail. The injunction was later overturned by a hi gher court at the request of the Trump administration.

In a letter to ACOG, acting FDA commissioner Janet Woodcock noted that studies done during this six month period “do not appear to show increases in serious safety concerns” like hemorrhage, ectopic pregnancy or surgical interventions.

ACOG has long argued that the in person dispensing requirements are politically motivated at aimed at reducing access to abortion.

“We are pleased to see mifepristone regulated on the basis of the scientific evidence during the pandemic, rather than political bias against comprehensive reproductive health care, and we look forward to working with policy makers to ensure this principle governs post-pandemic care,” Phipps said.


Source: modernhealthcare.com

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