Abortion pills to become available at retail, online pharmacies under 2023 FDA change
The U.S. Food and Drug Administration will allow select retail and online pharmacies in the United States to provide abortion pills to people with prescriptions, in a move that will greatly increase the availability of the medication at a time when many states are trying to limit these measures.
The two biggest pharmacy chains — CVS Health Corp. and Walgreens — quickly confirmed they would seek to become certified to sell the drugs, often known by the brand name Mifeprex. “We plan to seek certification to dispense mifepristone where legally permissible,” CVS said in a statement.
“We are working through the registration, necessary training of our pharmacists, as well as evaluating our pharmacy network in terms of where we normally dispense products that have extra FDA requirements and will dispense these consistent with federal and state laws,” a Walgreens spokesman told medical publication STAT News on Wednesday.
The FDA altered its requirements for selling mifepristone on Tuesday, allowing retail pharmacies to offer the medication for the first time.
All pharmacies must first complete an FDA certification process before they can fill prescriptions for the abortion pills.
What has changed?
Before the rule change, mifepristone was only available through certain mail-order pharmacies and clinics. And prior to the pandemic, people were required to pick up the medication in person.
Mifepristone has been available since 2000 and used by an estimated 3.7 million people. More than half of abortions in the U.S. are now induced by medications.
“If Walgreens leads the way, others will likely follow,” University of Pittsburgh health law professor Greer Donley told STAT News. “Clearly, they think the benefits outweigh the burdens.”
The FDA’s final rule change on Tuesday comes during a period when an increasing number of states are seeking to ban abortion pills, emboldened by the U.S. Supreme Court’s decision in June to overturn Roe v. Wade. The Supreme Court decision eliminated a woman’s constitutional right to an abortion in the United States after nearly 50 years.
While the FDA’s move is meant to make getting an abortion easier in the United States, it won’t change the medication abortion process in Florida, according to Laura Goodhue, vice president of public affairs at Planned Parenthood of South, East and North Florida.
A prescription is still required
The FDA is allowing certified pharmacies to dispense mifepristone to people who have a prescription. It’s no longer requiring patients seeking an abortion to get the first of the two drugs in person at a doctor’s office, hospital or health center. (The FDA temporarily lifted this mandate during the COVID-19 pandemic to let people receive the medication by mail, pending state law)
Mifeprex (mifepristone) and its generic version, Mifepristone tablets, 200 mg, is a medication that when used together with another medicine called misoprostol, can end pregnancy through week 10, according to the FDA, which approved the medication more than 20 years ago to a limited number of specialized offices and clinics. The FDA approved Mifepristone’s generic counterpart in 2019.
Under the new regulations, certified healthcare providers can prescribe the abortion-inducing medication and the patient can go pick up the pills at a certified pharmacy or have the pharmacy mail it to them, just like they would other medications. Both CVS Health and Walgreens said they’re reviewing the FDA’s updated guidelines.
In order to be certified, healthcare providers and pharmacies will have to submit a form with the FDA and get the agency’s approval.
The Supreme Court’s decision in June to overturn Roe v. Wade, the 1973 landmark Supreme Court decision giving women across the United States the constitutional right to an abortion, has led some states to rewrite their abortion laws, including outlawing the procedure.
So far, abortion is illegal now in 12 states and 18 states have banned access to medication abortion via telemedicine, according to the Center for Reproductive Rights. Oregon, meantime, has been a leader in providing abortion services through telemedicine.
Legal experts say they foresee years of court battles over access to the pills.
–The Associated Press, Tribune News Service and Bloomberg contributed