Arizona law OKs off-label drug promotion, contradicts FDA rules

 Arizona Republican Gov. Doug Ducey on March 21 signed a bill into law that allows drug and device companies to promote off label uses of their drugs to clinicians, reports The Arizona Republic.

While physicians are allowed to — and commonly do — prescribe drugs to patients for uses not approved by the Food and Drug Administration, the agency prohibits drug and devicemakers from marketing their drugs for these off label uses.

"The drugs are legal. Prescribing is legal. The only thing illegal was for the [drug] company to talk to the physician about off-label uses," Arizona Rep. Phil Lovas, R-Peoria, told The Arizona Republic.

The law, called the Free Speech in Medicine Act, passed the Arizona Senate in a 29-0 vote and the House in a 60-0 vote. Under the law, company representatives can share drug and device information with clinicians that is "not misleading, not contrary to fact and consistent with generally accepted scientific principles," according to the report.

Despite the new law, companies may be hesitant to promote off label uses as they operate on a national level and still report to the FDA under federal law, according to The Arizona Republic.

More articles on supply chain:

Mallinckrodt drops out of PhRMA
FDA approves more drugs, faster than EU regulator: 4 findings
FDA nominee Dr. Scott Gottlieb's confirmation hearing: 6 things to know

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars

>