US Health Authority Allows Abortion Pills to be Sold in Retail Pharmacies

Illustration. (Unsplash/Gayatri

JAKARTA - The United States Food and Drug Administration (FDA) will allow retail pharmacies to offer abortion pills in the United States for the first time, the agency said Tuesday, as more states seek to ban medication abortion.

Regulatory changes have the potential to 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 decision and the state ban that followed.

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 will be able to dispense it directly to patients, upon receiving a prescription from a certified prescriber.

The FDA first said it would make the change in December 2021, when it announced it would relax some of the risk evaluation and mitigation strategies, or REMS, on pills, that have been in place since the agency approved them in 2000 and were temporarily lifted in 2021 due to the COVID-19 pandemic. .

The changes include permanently removing restrictions on mailing pills and prescriptions via telehealth.

The agency finalized the changes Tuesday, after reviewing additional applications from Danco Laboratories and GenBioPro, the two companies that make the drug in the United States.

"Under the Mifepristone REMS Program, as modified, Mifeprex and its approved generic drugs may be dispensed by a certified pharmacy or by or under the supervision of a certified prescriber," the agency said on its website on Tuesday.

Mifeprex is the brand name version of mifepristone combined with a second drug called misoprostol, which has a variety of uses including management of miscarriages, inducing abortions up to 10 weeks into pregnancy in a process known as medicinal abortion.

Abortion rights activists say the pill has a long track record of being safe and effective, without the risk of overdose or addiction. In some countries, including India and Mexico, women can buy it without a prescription to have 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 prescription abortion drugs by mail or pick them up directly from the pharmacy like any other prescription, is a game changer for people trying to access basic health care," Johnson added.

The regulatory change, however, would not provide equal access for everyone, GenBioPro, which makes a generic version of mifepristone, said in a statement.

Abortion bans, some targeting mifepristone, have been in place in more than a dozen states since the US Supreme Court overturned the constitutional right to terminate a pregnancy when it overturned the Roe v. Wade in 1973 last year. Women in the country have the potential to travel to other states for medical abortions.

Meanwhile, Marjorie Dannenfelser, president of the anti-abortion group SBA Pro-Life America, said the FDA's latest move endangers the safety of women and the lives of unborn children.

"State lawmakers and Congress must stand as a bulwark against the Biden Administration's pro-abortion extremism," he said in a statement.

Note that 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 estimated 4.9 million people who have taken it since it was approved in September 2000.

Retail pharmacies should consider whether or not to offer the pill given the political controversies surrounding abortion, and determine where they can do so.

A CVS Health spokesperson said the drugstore chain's owner is reviewing the 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."

Meanwhile, a spokesman for Walgreens, one of the largest pharmacies in the US, said the company is also reviewing changes to FDA regulations.

"We will continue to enable our pharmacists to dispense medications compliant with federal and state laws."