Government Healthcare Policy, Business and Technology

Will Arizona's Off-Label Drug Law Spur Changes Elsewhere?

Stateline: When the Food and Drug Administration gives its OK for a new drug to be sold, it specifies the diseases or conditions for which the medicine has been approved. That does not mean doctors can’t prescribe that prescription drug for other diseases and conditions. They do. All the time. And it’s perfectly legal.

But for decades drugmakers couldn’t actively promote the use of their drugs in ways that hadn’t gone through rigorous testing in clinical trials. The FDA, worried about safety issues, has prosecuted numerous drugmakers for illegal promotion of off-label uses and extracted billions of dollars in fines and settlements.

Those restrictions could be giving way, in part due to the appointment of Scott Gottlieb as the new FDA commissioner in May. Prior to his nomination, Gottlieb, a resident fellow at the conservative American Enterprise Institute and a doctor, advocated loosening the restrictions on off-label communications.

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