Florida health agency issues notice to providers following FDA decision on mifepristone

JACKSONVILLE, Fla. – The state of Florida’s health care regulator is pushing back against a regulatory change recently made by the Food and Drug Administration that paves the way for the sale of mifepristone at retail pharmacies.

After the FDA approved the sale of mifepristone, an abortion pill used to terminate a pregnancy up to 10 weeks, at retail pharmacies, big companies like Walgreens and CVS said they would sell it in their stores as long as it was legal in the state. But in Florida, it looks like that’s not going to happen.

On Tuesday, the Agency for Health Care Administration in Florida issued a notice, reminding providers that they “must continue to comply with Florida laws that govern the performance of abortions.”

It makes note of two Florida statutes, writing:

“First, section 390.0111(2), Florida Statutes, provides that ‘[n]o termination of pregnancy shall be performed at any time except by a [licensed] physician.’ Second, section 797.03 (1), Florida Statutes, states that ‘[i]t is unlawful for any person to perform or assist in performing an abortion on a person, except in an emergency care situation, other than in a validly licensed hospital or abortion clinic or in a physician’s office.’”

The notice states that violating the provisions could result in criminal penalties, and it says it will referring to local law enforcement “any evidence of criminal activity” discovered in surveys of providers.

“So it was very clear to us that it is not legal to do so in a community pharmacy,” said Dr. Kevin Duane, a pharmacist and owner of Panama Pharmacy.

Duane said the state is using existing laws to take a stance against the pregnancy-ending drug, threatening legal action for anyone in violation.

News4JAX asked Duane what safety concerns he has about it being dispensed at a pharmacy versus a licensed and certified doctor’s office.

“I think anytime you expand access, you worry that the setting is not appropriate for it. You worry about increased risk of bleeding with this drug, hemorrhaging. The drug is not benign. There’ve been several dozen deaths attributed to it,” Duane said.

LINK: FDA’s questions and answers: Mifepristone for medical termination of pregnancy through 10 weeks gestation

Duane said there will likely be legal challenges to the rules, but for now, the state laws will take precedence over the FDA approval.

The medication was previously only available for people to get at an authorized doctor’s office or through special mail order.

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Lifetime Jacksonville resident anchors the 8 and 9 a.m. weekday newscasts and is part of the News4Jax I-Team.