The regulatory change will potentially expand abortion access as President Joe Biden's administration wrestles with how best to protect abortion rights after they were sharply curtailed by the Supreme Court's decision to overturn the landmark Roe v Wade ruling and the state bans that followed.
Pharmacies can start applying for certification to distribute the abortion pill mifepristone with one of the two companies that make it, and if successful they will be able to dispense it directly to patients upon receiving a prescription from a certified prescriber.
Abortion rights activists say the pill has a long track record of being safe and effective, with no risk of overdose or addiction. In several countries, including India and Mexico, women can buy them without a prescription to induce abortion.
Abortion bans, some targeting mifepristone, have gone into effect in more than a dozen states since the USSupreme Court overturned the constitutional right to terminate pregnancies when it scrapped the 1973 Roe v. Wade ruling last year.
Women in those states could potentially travel to other states to obtain medication for abortion.
The president of the anti-abortion group SBA Pro-Life America, Marjorie Dannenfelser, said the latest FDA move endangers women's safety and the lives of unborn children.
FDA records show a small mortality case number associated with mifepristone. As of June 2021, there were reports of 26 deaths linked with the pill out of 4.9 million people estimated to have taken it since it was approved in September 2000.
Retail pharmacies will have to weigh whether or not to offer the pill given the political controversy surrounding abortion and determine where they can do so.
A spokesperson for CVS Health said the drugstore chain owner was reviewing the updated REMS "drug safety program certification requirements for mifepristone to determine the requirements to dispense in states that do not restrict the dispensing of medications prescribed for elective termination of pregnancy."
A spokesperson for Walgreens, one of the largest U.S. pharmacies, said the company was also reviewing the FDA's regulatory change.
Reuters