Foley & Lardner LLP partner Kyle Faget commented in Inside Telehealth on proposed California legislation that could authorize in‑state production of mifepristone even if the U.S. Food and Drug Administration withdraws federal approval.
The bill’s provision suggests that if mifepristone loses FDA approval, California may no longer be bound by federal labeling requirements. “If it’s not an approved product, then the labeling requirements applicable to approved products aren’t going to apply anymore,” Faget explained. “What California is possibly signaling there is that even if FDA withdraws approval of mifepristone, California might continue to dispense mifepristone anyway.”
The measure revises the state’s shield law to apply broadly to providers licensed in California — regardless of patient location — granting authority to determine what personal information is included on mifepristone prescriptions. Faget noted the potential conflict if such a prescription crosses state lines. “If that prescription ends up in Texas,” she said, “certainly Texas could argue, ‘Hey, you’re not following the Federal Food, Drug & Cosmetic Act,’ and that’s where I think you could run into a problem.”
Faget added that the bill’s outcome could influence telemedicine prescribing regulations more broadly, as providers await the U.S. Drug Enforcement Administration’s decision on extending remote prescribing flexibilities for controlled substances.
“There were some states that said, ‘You know what? According to our state requirement, you don’t need to have the Ryan Haight in-office visit, not according to this state,’” she said. “But there’s still the federal requirement that you do. So again, it’s an issue of enforcement.”
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