Abortion Pills Can Now Be Offered at Retail Pharmacies, F.D.A. Says

The FDA made a regulatory change Tuesday that will allow retail drugstores to sell abortion pills in the US. Access to abortion could be expanded through medication.

Until now, the first pill used in the two-drug abortion regimen was only available by mail order. Patients will still need a prescription from a certified health care provider, but any pharmacy that agrees to accept those prescriptions and abide by certain other criteria can distribute the pills in its stores and by mail order.

The change comes as abortion pills, already used in more than half of pregnancies in the U.S., are becoming even more sought after in the wake of last year's Supreme Court decision. With conservative states banning or sharply restricting abortion, the pills have become the focus of political and legal battles, which may affect a pharmacy's decision about whether or not to distribute the medication.

The F.D.A. did not make an announcement but did plan to update its website. The agency informed the makers of the pill of the action.

Since it was approved in 2000, the federal government has taken a number of steps to increase access to abortion pills.

In December of 2021, the F.D.A. said it would permanently remove the requirement for patients to get the abortion pill in person from a health provider.

The F.D.A. removed the in-person requirement on Tuesday and left in place two other requirements: that health providers be certified to show they have the knowledge and ability to treat abortion patients and that patients complete a consent.

It is authorized by the F.D.A. to be taken in the first 10 weeks of a pregnant woman's life, but many clinics and providers have begun offering it up to 12 or 13 weeks into the baby's life.

The second drug in the regimen, misoprostol, is easy to get at the pharmacy and is used for many different conditions. It takes 24 to 48 hours after the birth of a baby for the drug to kick in.

There was an agreement between the F.D.A. and the companies that made the pills. The agreement was worked out in negotiations that took about a year and considered issues such as whether to allow pharmacies to offer the pills in stores or only via mail order and how to keep the identity of prescribers confidential to protect their privacy and safety.

It wasn't immediately clear if local drugstores would make the pills available. There are some administrative requirements that go beyond the process pharmacy use with most other medications, such as designating an employee to ensure compliance, when it comes to becoming certified to deliver Mifepristone. The time and resources required by those steps may make it hard for a pharmacy to offer a medication that is only used by a small percentage of their customers.

While abortion pills may make up a small percentage of a pharmacy's sales, they could have a big impact on its public image. Pharmacy decisions are likely to be influenced by public perception and politics.

It would be very difficult for a pharmacy to provide abortion pills if the state had an abortion ban.

In states where abortion is legal, pharmacies may face customer demand for the medication or public pressure. If national chains decided to offer the medication in those states, they would not provide it in their stores in restrictive states.

The drug is only approved for abortions. There may be pressure on the pharmacy to give it for the treatment of some miscarriages. Dozens of groups, including the American College of Obstetricians and Gynecologists and the American Medical Association, filed a citizen petition asking the F.D.A. to take action to make it easier for women to use the drug for fertility reasons.

An official with Danco, which for years was the only company to produce the medication, said the company expected that smaller independent pharmacies would be first to sell the drug and that it might take the bigger chains longer.

The official spoke on the condition of anonymity because of the company's concerns about threats from abortion opponents. An official with Danco said that a chain like CVS would not be able to list a doctor's name in a companywide database, and would have to keep that information restricted to the store that filled that doctor's prescriptions.

The company wasn't expecting a boom in sales from the rule change, so she predicted that small pharmacies that typically serve university health services or retail pharmacy on hospital campuses would be the first to adopt. She said it was possible that more health care providers would become prescribers if they were able to write prescriptions that were filled at the pharmacy.

For some people, this will be a huge improvement on their ability to access the drug and be able to make their own decisions. It's not for other people. They might not want to go to their mom-and-pop pharmacy. They prefer receiving it from a mail order.

The F.D.A. announcement expands access to medications that are essential for reproductive autonomy and is a step in the right direction.