The abortion drug mifepristone is safe enough that local pharmacies can supply the drug as long as it is prescribed by a certified healthcare provider and that pharmacy meets certain requirements, according to new rules released Tuesday by the US Food and Drug Administration.
If pharmacies jump on board, the FDA’s decision could expand access to the drug in states where it’s already legal. Doctors, for example, might be more willing to get certified to prescribe the drug because they would no longer need to store it themselves and could write a prescription like they would any other drug.
The new rule also opens the door to a new round of legal challenges. Abortion rights advocates have been expected to use the latest regulatory update to argue that under the law, only the FDA — not state governments — can decide which drug is safe enough to be sold in pharmacies.
In a statement, Evan Masingill, CEO of GenBioPro, which makes the generic version of the abortion pill, called the FDA action “a step in the right direction” to improve access and one that “relieves the burden on the health care system.” would minimize.
“Despite the FDA’s expert judgment, some states have restricted access to medical abortion treatment, so unfortunately today’s announcement will not grant equal access to all people,” Masingill said. “GenBioPro looks forward to working with prescribers and pharmacies to improve access to medical abortion treatment for all people.”
Mifepristone, also sold under the brand name Mifeprex, is FDA approved to terminate pregnancy up to 10 weeks. The single pill blocks the hormone progesterone and is typically paired with a second drug, misoprostol, which causes spasms to empty the uterus. However, only mifepristone is subject to a special regulatory framework used by the FDA to minimize the risks of certain drugs.
An estimated half of abortions now rely on the drug, with the rest being performed surgically.
The FDA did not issue a formal statement Tuesday, but updated information about the drug online. Since 2021, the FDA has said mifepristone is safe enough for certified providers to prescribe it via telemedicine and ship the drug directly to the patient. However, the FDA had no plan until this week to give pharmacies the green light to supply the drug, limiting distribution access mainly to abortion clinics that could stock the drug.
Kirsten Moore, director of the Expanding Medication Abortion Access Project, said it’s not clear how quickly Americans might see an impact or how far-reaching these changes might be. Pharmacies would have to raise their hand to be allowed to fill the prescription for the drug, and even then some pharmacists might refuse to personally dispense the pill because of religious objections.
Still, she said, the FDA’s action signals a federal government intention to treat the drug more like other drugs.
“This is a product that’s been niche for a long time,” Moore said. “But this is definitely a step towards mainstreaming this drug.”
Opponents of abortion rights say the top priority this year is to challenge the drug’s FDA approval in court and try to convince the government to crack down on unregulated websites selling the pill online. In a closely watched case in Texas federal court, the Alliance for Defending Freedom argued that the FDA exceeded its powers when it gave the drug the green light more than two decades ago.
Supporters of abortion rights counter that the FDA’s power to decide which drugs to sell to consumers is rooted in federal law and that states have no authority to block it.
In an interview last month before the FDA’s announcement, Kristan Hawkins, president of the anti-abortion rights group Students for Life, said she believes there is enough political support in some conservative states to crack down on the illegal sale of mifepristone.
However, she acknowledged that the widespread availability of mifepristone has made work difficult for the anti-abortion rights movement, even after the Supreme Court Roe v. Wade had fallen.
“I think when it comes to chemical abortion, we have an uphill battle,” she said.
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https://abc7.com/abortion-pill-fda-mifepristone-pharmacies/12647702/ The FDA will give pharmacies the green light to fill prescriptions for the abortion pill mifepristone, the agency says