Alabama enacts law to protect physicians prescribing off-label medications

Sen. Arthur Orr, R-Decatur, reads documents in the Alabama Senate on May 8, 2024 at the Alabama Statehouse in Montgomery, Alabama. (Brian Lyman/Alabama Reflector)

Gov. Kay Ivey signed a bill Thursday prohibiting the Alabama Board of Medical Examiners and the Medical Licensure Commission of Alabama from taking adverse action against a physician who prescribes or recommends off-label medical treatments.

SB 72 , sponsored by Sen. Arthur Orr, R-Decatur, passed out of both chambers unanimously.

“This bill just allowed a doctor to do what they’re already doing without any fear of reprisal from the State Medical Board,” Orr said in a phone interview Friday, adding that often there are FDA drugs that can be beneficial in treating ailments they were not initially intended for.

Off-label use refers to prescribing an approved drug for an unapproved disease or condition, administering it in a different form, or giving it in a different dose than approved, according to the U.S. Food and Drug Administration . Once the FDA approves a drug, healthcare providers may prescribe it for an unapproved use if they believe it is medically appropriate for their patient.

The bill was significantly changed from the introduced version. Orr said the changes were a recommendation from the Alabama Board of Medical Examiners to make it more “succinct.”

The introduced bill would have prohibited any state board, agency or commission from taking action against a doctor. The amended version narrowed it down to two agencies. The previous bill also would have given doctors the right to sue the state if they were subject to punishment.

Orr said that the issue became more prominent at the beginning of the COVID-19 pandemic when doctors in some states were threatened by their state’s medical authorities with adverse action for prescribing off-label treatment for COVID-19.

Off-label prescribing, common during the pandemic, raised scientific and ethical concerns due to limited data on safety and efficacy, according to the American Medical Association . Physicians were advised to base prescriptions on medical needs and reasonable expectations, to assess evidence, consult peers and obtain patient consent, explaining risks and benefits.

At least 20 doctors across the U.S. faced punishment for complaints related to COVID misinformation, according to a Washington Post investigation. Five lost their licenses.

Dr. David Williams, a Tuscaloosa doctor who brought the issue to Orr’s attention,  said that he felt a responsibility to offer off-label treatment in the beginning of the pandemic when there was no treatment for COVID yet. Before the FDA approved Paxlovid to treat COVID, the general recommendation when someone became sick with COVID was to stay home, unless they needed immediate medical attention. Williams said he wanted to do more for his patients.

“There’s no other condition in medicine where we’re like, the best thing to do is nothing and just hope for the best. If your foot is infected, let’s see if we can get that fixed before your foot rots,” he said.

Williams said he prescribed the anti-parasitic drug ivermectin for patients, even though ivermectin hadn’t been studied at the time as a treatment for COVID. Williams said felt it was FDA approved for other conditions and thus safe to use for humans, and that it was “not like pulling something off the industrial shelf.”

The FDA has since found that current clinical trial data does not support ivermectin being effective against COVID-19. Ivermectin is approved to treat certain parasitic worms in humans. In animals, different forms of ivermectin, like pour-on, injectable, paste, chewable, and drench, are approved to treat or prevent parasites.

Prescribing off-label medication is not new to the medical profession, Williams said, and he did not foresee this bill being needed before the pandemic.

“I think some people might get the impression that these things are done kind of cavalier. They’re really not. They’re usually done on medicines that we are very comfortable with already, and that we just see another benefit,” he said.

Both Orr and Williams said there were no threats of adverse action in Alabama.

When asked about the potential for abuse or unintended consequences, such as prescribing off-label medicines that have been less studied and are new to the market, Williams said that it’s the physician’s role to look at the risks and benefits of any medication and to inform the patient of what they know and don’t know.

For a medication like Ozempic, which was approved by the FDA in 2017 to treat type 2 diabetes and is increasingly prescribed off-label for weight loss, Williams said he would tell his patients that he can’t tell them what will happen in 20 years.

“Nobody will ever have time, resources to study every medicine for everything it might or could possibly do. So it’s trying to pick up benefits when we can, because if we had to wait years to use them for a certain indication if we don’t use them off-label,” he said.

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