FDA to allow abortion pills in the mail during pandemic

The Biden administration has decided to allow women to receive abortion pills by mail for the duration of the coronavirus pandemic, the latest development in an issue that is increasingly coming to the fore in the American debate over abortion.

In one letter Sent Monday to two leading organizations representing reproductive health physicians, the acting commissioner of the Food and Drug Administration said the agency would temporarily stop enforcing its requirement that the first of two drugs needed to discontinue a early pregnancy should be issued in a medical clinic.

The new policy contradicts a Supreme Court ruling in January that sided with the Trump administration, which appealed a federal judge’s decision last July to suspend the requirement. The judge had argued that this requirement put women at risk during the pandemic because they would have to attend clinics in person and often travel significant distances to do so.

Medical abortion, first approved by the FDA in 2000, is increasingly becoming women’s preferred method of terminating a pregnancy. In 2017, research estimated that about 60% of patients who had an abortion early enough in pregnancy to be eligible — 10 weeks pregnant or less — chose medical abortion over aspiration or surgery.

But the FDA requires that the first drug in the two-drug regimen, mifepristone, be dispensed in clinics or hospitals by specially certified physicians or other medical providers. For years, reproductive health experts have urged that the requirement be lifted on the grounds that there are no significant safety reasons for the in-person distribution of a pill that women are then legally allowed to take. take on their own anywhere, and that the restriction places the greatest burden on low-income women and those who live in areas with limited access to abortion providers.

For several years, with the authorization of the FDA, researchers have been carrying out a study which offers telemedicine consultations to women wishing to have an abortion and sends them the pills by mail. Their research found the approach to be safe and effective.

Additional data has been gathered in recent months from the experiences of women during the pandemic who received abortion pills in the mail after the judge lifted the restriction and before the Supreme Court reinstated it.

Dr. Janet Woodcock, acting commissioner of the FDA, wrote in her letter to the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine that studies of the pandemic experience “do not appear to show any increase in serious safety issues,” such as bleeding, ectopic pregnancy, or the need for surgical procedures “occurring with medical abortion as a result of the change in in-person delivery requirement during the Covid-19 pandemic.”

Groups that oppose abortion opposed the decision. Jeanne Mancini, president of March for Life, said in a statement that allowing medical abortion appointments via telemedicine posed a “serious danger” to women’s safety, adding that “chemical abortions should be ‘subject to greater medical surveillance’.

Health professional organizations and reproductive health groups, which sent a letter in March to President Biden and Vice President Kamala Harris asking the FDA to lift restrictions during the pandemic, welcomed the decision.

“Mifepristone itself has been shown, both through clinical studies and decades of use, to be a safe and effective drug,” said the president and CEO of the American College of Obstetricians. and Gynecologists in a statement. “Requiring that the drug be dispensed in person and then taken elsewhere at the patients’ discretion is arbitrary and does nothing to enhance the safety of an already safe drug.”

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