By Corinne Murdock
State Senator Nancy Barto (R-Phoenix) reminded Arizonans last week that off-label treatments are legal during public health emergencies, including the COVID-19 pandemic. Barto cited her bill, SB1416, which was signed into law in May.
Barto explained the significance of the law during a radio interview on Monday. According to the senator, the law grants flexibility for health care providers to offer more tailored treatments to their patients.
“We know how important early treatment and prevention is in health care,” said Barto. “Expanding access to certain off-label medications during a pandemic can be life-saving in this fight, and physicians need every tool in the toolbox to appropriately treat patients without fear of losing their license.”
Last month, Governor Doug Ducey rescinded restrictions on the filling of two off-label drugs some prescribed for COVID-19: hydroxychloroquine and chloroquine. This further allowed health care providers flexibility, complementing Barto’s law:
“ ‘Lawful health care service’ means any health-related services or treatment, to the extent that the service or treatment is allowed or prohibited by law or regulation, including the off-label use of medications during a public health emergency, that may be provided to persons or businesses that are otherwise allowed to offer such services,” reads the law. “‘Off-label use’ means any use if the intent is the practice of medicine and the use is not specified in the labeling or indications for use for prescription drugs, biologics, approved medical devices and dietary supplements approved by the United States food and drug administration.”
Hydroxychloroquine and chloroquine aren’t recommended currently by the FDA to treat COVID-19. The FDA cautioned that the drug could cause heart rhythm problems, and the National Health Institute (NIH) assessed that it could work in theory but has failed in terms of both safety and efficacy.
In the case of COVID-19, treatments like Ivermectin have been popularized as off-label treatment options. When previous President Donald Trump contracted COVID-19 last October, he was given a cocktail of off-label drugs including: dexamethasone, remdesivir, and Regeneron’s monoclonal antibody. The president was also given zinc, Vitamin D, famotidine, melatonin, and aspirin.
Those are a few of several treatments approved by the FDA. For more severe cases, patients may be given Veklury (remdesivir). Monoclonal antibody treatments include sotrovimab, REGEN-COV (casirivimab and imdevimab), and Olumiant (baricitinib). Other treatments include the immunosuppressive Actemra (tocilizumab).