WASHINGTON, Jan 3 – The U.S. Food and Drug Administration (FDA) will allow retail pharmacies to sell abortion pills in the United States for the first time, the agency said on Tuesday, even as more states seek to ban abortion.
The regulatory change will potentially expand access to abortion as President Joe Biden’s administration grapples 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 and the state bans that followed.
Pharmacies can begin applying for certification to distribute the abortion pill mifepristone from one of the two companies that make it, and if successful, will be able to dispense it directly to patients after receiving a prescription from a certified prescriber.
The FDA first said it would make the changes in December 2021, when it announced it would loosen some of the risk evaluation and mitigation strategies, or REMS, on the pill that had been in place since the agency’s approval in 2000 and had been temporarily lifted. in 2021 due to the COVID-19 pandemic.
The changes included the permanent removal of restrictions on mail order pills and telehealth prescribing.
The agency finalized the changes Tuesday after reviewing supplemental applications from Danco Laboratories and GenBioPro, two companies that manufacture the drug in the United States.
“Under the amended Mifepristone REMS program, Mifeprex and its approved generics may be dispensed by or under the supervision of certified pharmacies or certified prescribers,” the agency said on its website Tuesday.
Mifeprex is a brand-name version of mifepristone that, when combined with a second drug called misoprostol, which has a variety of uses including abortion management, induces a miscarriage up to 10 weeks into a pregnancy in a process known as medical abortion.
Abortion rights activists say the pill has a long history 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 an abortion.
“Today’s news is a step in the right direction for health equity,” Planned Parenthood President Alexis McGill Johnson said in a statement.
“Being able to access a prescription abortion through the mail or pick it up in person at a pharmacy like any other prescription is a game-changer for people trying to get basic health care,” Johnson added.
NO EQUAL ACCESS
However, the regulatory change will not ensure equal access for all people, GenBioPro, which makes the generic version of mifepristone, said in a statement.
Abortion bans, some targeting mifepristone, have taken effect in more than a dozen states since the U.S. Supreme Court struck down the constitutional right to terminate a pregnancy when it overturned the 1973 Roe v. Wade ruling last year.
Women in these states could potentially travel to other states to obtain a medical abortion.
Marjorie Dannenfelser, president of the anti-abortion group SBA Pro-Life America, said the FDA’s latest move threatens the safety of women and the lives of unborn babies.
“State lawmakers and Congress must stand as a bulwark against the pro-abortion extremism of the Biden administration,” she said in a statement.
FDA records show a small number of deaths related to mifepristone. As of June 2021, there have been reports of 26 deaths linked to the pill out of an estimated 4.9 million people who have taken it since it was approved in September 2000.
Retail pharmacies will have to consider whether or not to offer the pill given the political controversy surrounding abortion and determine where they can do so.
A spokesman for CVS Health ( CVS.N ) said the drugstore chain’s owner is reviewing updated “REMS drug safety program certification requirements for mifepristone to determine dispensing requirements in states that do not restrict dispensing of the drug prescribed for elective termination of pregnancy.” .”
A spokesman for Walgreens ( WBA.O ), one of the largest U.S. drugstores, said the company was also reviewing the FDA’s regulatory change. “We will continue to allow our pharmacists to dispense medications in accordance with federal and state law.”