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Abortion Pill In-Person Dispensing Rule Permanently Nixed by FDA (2)

Dec. 16, 2021, 9:37 PMUpdated: Dec. 17, 2021, 12:00 AM

People seeking to end an early pregnancy will no longer need to physically visit a medical provider to receive the pill mifepristone as the Supreme Court weighs a case that will determine the fate of Roe v. Wade, the landmark ruling that legalized abortion nationwide.

The Food and Drug Administration’s Thursday decision will make it easier for women to access the drug, especially if Roe is overturned and states begin imposing additional abortion restrictions. The high court case, over a Mississippi law, had intensified pressure on the FDA to permanently nix the in-person dispensing rule for mifepristone.

The agency’s 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. The FDA had temporarily suspended the longstanding in-person dispensing requirement for the duration of the public health emergency.

Permanently allowing women to access mifepristone via telemedicine or mail-order pharmacy marks a win for abortion rights advocates and some lawmakers. But Republicans and anti-abortion activists say maintaining restrictions on mifepristone access is necessary to protect women against potential side effects from using the drug.

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 argue 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.

The policy change will remove “the requirement that mifepristone be dispensed only in certain healthcare settings, specifically clinics, medical offices, and hospitals,” according to the update. The FDA said 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.

‘Crucial Step’

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.”

“Today, after reviewing years of evidence on the safety and effectiveness of medication abortion care, the FDA removed some outdated barriers,” said Kirsten Moore, director of the Expanding Medication Abortion Access (EMAA) Project. “The in-person dispensing requirements on medication abortion care have proven to be unnecessary during the pandemic, and the FDA did the right thing today by lifting them.”

But Susan B. Anthony List, a pro-life group, said in a statement that the policy change “allows for dangerous at-home, do-it-yourself abortions without necessary medical oversight.”

“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.”

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 is overturned.

If Roe is overturned, however, people living in states with abortion restrictions could still get mifepristone through telemedicine from a doctor practicing in a different state under the FDA’s rule change, abortion advocates say.

Sen. Roger Marshall (R-Kan.), a physician, questioned President Joe Biden’s nominee for FDA commissioner, Robert Califf, on the 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.

(Updated with comment from Susan B. Anthony List in the 14th and 15th paragraphs.)

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com