Regulatory change to expand access to abortion comes after more than a dozen states banned abortion.
The U.S. Food and Drug Administration (FDA) will allow retail pharmacies to offer abortion pills in the United States for the first time, the agency said, even as more states try to ban medication abortion.
“Under the Mifepristone REMS Program, as amended, Mifeprex and its approved generic drugs may be dispensed by certified pharmacies or under the supervision of a certified prescriber,” the agency said on its website Tuesday.
The rule change will potentially increase access to abortion as President Joe Biden’s administration grapples with how best to protect abortion rights after they were sharply curtailed last year by the Supreme Court’s decision to overturn the milestone Roe v Wade ruling and the state bans that followed.
The agency finalized the changes after reviewing additional applications from Danco Laboratories and GenBioPro, the two companies that make the drug in the US.
Pharmacies can begin applying for certification to distribute the Mifepristone abortion pill with one of the two companies that make it, and if successful, they can dispense it directly to patients upon receipt of a prescription from a certified prescriber.
The FDA first said it would make those changes in December 2021, when it announced it would relax some risk assessment and risk mitigation strategies, or REMS, for the pill that had been in place since the agency approved it in 2000. approved and were temporarily suspended in 2021 due to the COVID-19 pandemic.
The changes include permanently removing restrictions on mail-order shipping of the pills and prescribing them through telehealth — or remote care.
Mifeprex is the brand name version of mifepristone which, when combined with a second drug called Misoprostol which has various uses including miscarriage management, causes abortion up to 10 weeks into pregnancy in a process known as medication abortion.
Abortion rights activists say the pill has a long track record safe and effective, without the risk of overdose or addiction. In several countries, including India and Mexico, women can buy them without a prescription to induce an abortion.
“Today’s news is a step in the right direction for health equity,” Alexis McGill Johnson, president of Planned Parenthood, said in a statement.
“Being able to access your prescription abortion medication through the mail or pick it up in person from a pharmacy like any other prescription is a breakthrough for people trying to access basic health care,” Johnson added .
However, the regulatory change won’t provide equal access to all people, GenBioPro, which makes the generic version of mifepristone, said in a statement.
Abortion bans, some targeting mifepristonehave come into effect in more than a dozen states since the U.S. Supreme Court overturned the constitutional right to terminate pregnancies when it struck down the 1973 Roe v Wade ruling.
Women in those states could potentially travel to other states to obtain abortion drugs.
The president of the anti-abortion group SBA Pro-Life America, Marjorie Dannenfelser, said the FDA’s latest move puts the safety of women and the lives of unborn children at risk.
“State legislators and Congress must build a bulwark against the Biden administration’s pro-abortion extremism,” she said in a statement.
FDA records show a small number of deaths associated with mifepristone. As of June 2021, there were reports of 26 deaths related to the pill out of the 4.9 million people estimated to have taken the pill since its approval in September 2000.