People will have an easier time getting pills to end early pregnancy after the FDA nixed a requirement that they must physically visit a medical provider for the drug—a boon to abortion rights advocates as they await a Supreme Court decision that could determine the fate of Roe v. Wade.
The Food and Drug Administration on Thursday said people no longer need to go to certain health-care settings, such as clinics, medical offices, and hospitals, to get the drug mifepristone. If Roe is overturned, those living in states with new abortion restrictions may still be able to get mifepristone through telemedicine from a doctor practicing in a different state, some advocates say.
The FDA had temporarily suspended the longstanding in-person dispensing requirement for mifepristone for the duration of the Covid-19 public health emergency. The high court case, over a Mississippi law, had intensified pressure on the agency to permanently remove that requirement.
Republicans and anti-abortion activists, however, have said maintaining restrictions on mifepristone access is necessary to protect women against potential side effects from using the drug.
The agency said its decision followed a full review into whether existing evidence indicates the drug is still safe and effective when patients pick it up at pharmacies or by mail.
Mifepristone’s in-person dispensing rule was part of the drug’s risk evaluation and mitigation strategy (REMS), a safety program the FDA uses to make sure the benefits of a medication outweigh its risks. Doctors and abortion rights advocates argued the rule is no longer necessary due to research on the drug’s safety since the FDA first granted approval more than two decades ago.
“FDA determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks,” the agency said in an update on its website. It is also adding a requirement that pharmacies that dispense the drug be certified.
The agency said in April that it was temporarily lifting the dispensing requirement after health-care providers sued the agency in May 2020, citing safety concerns amid the rapid spread of Covid-19. The case was subsequently dismissed.
The FDA received praise from lawmakers and abortion rights groups over its change to mifepristone’s REMS program.
“Removing the in-person dispensing requirement to medication abortion care is a crucial step toward ensuring that all people can exercise their constitutional right to abortion without stigma or delay,” Rep. Carolyn Maloney (D-N.Y.), chairwoman of the House Committee on Oversight and Reform, said in a statement Thursday.
“I applaud the FDA’s momentous decision to lift medically unnecessary restrictions on mifepristone, which will expand access to abortion care for patients across the country,” Maloney said. She added that the move is “particularly important for people of color, people in rural communities, and people with lower incomes, who are disproportionately harmed by abortion restrictions.”
Reproductive health advocacy group All Above All Co-Director Destiny Lopez called the move “an important step toward abortion justice.”
But pro-life groups said the policy change places women at risk.
The change “allows for dangerous at-home, do-it-yourself abortions without necessary medical oversight,” Susan B. Anthony List said in a statement.
“The Biden administration’s reckless move puts countless women and unborn children in danger,” Sue Liebel, the group’s state policy director, said. “Abortion activists’ longtime wish has been to turn every post office and pharmacy into an abortion center.”
Randall K. O’Bannon, director of education and research at National Right to Life, said in a statement that women “may not be adequately screened to make sure they have no disqualifying conditions like allergies or ectopic pregnancy and are not so far along that the drugs will not work or are more likely to result in life-threatening complications.”
The decision helps to expand access to the pill in the states where pharmacy dispensing of mifepristone is allowed, said Daniel Grossman, a professor at the University of California, San Francisco. Restrictions on mifepristone access still remain, however.
Alabama, Texas, and 17 other states, mostly Republican-controlled, have their own provisions requiring clinicians providing medication abortion to administer the drugs in person, effectively barring access via telemedicine or mail-order.
“The FDA must permanently lift all restrictions on medication abortion and states with politically motivated bans on medication abortion, particularly via telehealth, must reverse these policies so people can get care in a way that makes sense for them,” Lopez said.
Supreme Court Battle
Proponents of abortion access are bracing for a decision in Dobbs v. Jackson Women’s Health Organization, the Mississippi appeal that seeks to overturn Roe. The state law at issue there bans nearly all abortions after 15 weeks of pregnancy.
A decision upholding that law would give states new license to slash abortion access. And about a dozen states already have laws largely barring abortion that would be triggered if Roe—the landmark 1973 high court ruling that legalized abortion nationwide—is overturned.
Sen. Roger Marshall (R-Kan.), a physician, questioned President Joe Biden’s nominee for FDA commissioner, Robert Califf, on the mifepristone issue at his confirmation hearing Dec. 14.
Marshall asked Califf if he would ensure that the responsibility of dispensing abortion drugs be “in the hands of physicians and prescribers and not handed out like candy.”
Califf responded that he isn’t currently involved in the FDA’s internal discussions on mifepristone, but added that he trusts “FDA staff to make good decisions.”
“The FDA has to make this decision based on the latest data and scientific principles,” Califf said.
To contact the reporter on this story:
To contact the editor responsible for this story: