Will the FDA Ease Restrictions on Off-Label Drug Use?

The U.S. Food and Drug Administration (FDA) is starting to feel pressure to loosen restrictions on off-label drug use after Arizona passed legislation allowing pharmaceutical manufacturers to communicate directly with health-care practitioners and insurance companies about alternative uses for approved products.

During the approval process, the FDA confirms a drug’s safety and efficacy for specific indications; once a drug is approved, though, physicians may prescribe it for off-label uses. The FDA bars pharmaceutical manufacturers from promoting their drugs for uses that haven’t been investigated in clinical trials, over concerns about patient safety.

According to The Washington Post, FDA Commissioner Scott Gottlieb, MD, previously advocated for loosening the restrictions as a physician and fellow at the American Enterprise Institute, a conservative policy research institute.

With the “Free Speech in Medicine Act,” Arizona is allowing pharmaceutical companies to directly communicate with physicians and insurance companies about off-label uses for approved drugs. The bill states that, “notwithstanding any other law, a pharmaceutical manufacturer or its representative may engage in truthful promotion of an off-label use of a drug, biological product, or device.”

Advocates of loosening off-label restrictions claim that open communication should be allowed if information is not misleading. Though off-label use is technically legal, opponents are concerned about public safety, arguing that, if the FDA has not approved a drug for off-label uses, then the manufacturer hasn’t produced evidence to demonstrate its safety and efficacy for those other uses.

The FDA issued draft guidance in January 2017 regarding how drug manufacturers can communicate supplementary data and information regarding alternative uses while remaining consistent with a product’s approved label.

Source: The Washington Post, October 8, 2017.