Arizona Law Puts Pressure on FDA to Loosen Restrictions on Off-Label Communications

Arizona is the first state to enact a law to allow drug companies to communicate off-label uses of their products. A conservative think tank is hoping other states will follow suit.

The Free Speech in Medicine Act (H.B. 2382), signed March 21 by Arizona Gov. Doug Ducey (R), allows drug companies to communicate with doctors and other health-care providers about safe and effective off-label uses for approved medical products. But it doesn’t permit manufacturers to advertise off-label uses directly to the public.

The legislation was drafted by the Goldwater Institute, a Phoenix-based think tank that advocates for limited government. It’s hoping that other states also enact the legislation in order to either push the Food and Drug Administration to allow off-label communication or force a Supreme Court case on the issue.

Doctors can prescribe drugs for off-label uses, meaning uses that aren’t approved by the FDA. However, drugmakers can’t promote or provide information about off-label uses.

Christina Sandefur, executive vice president of the Goldwater Institute and the person who drafted the legislation, told me there have been a series of court cases where drug companies have sued the FDA for not allowing them to share off-label information. The agency then settles with the company, which keeps any precedent from being set on this, she said. No case has ever gotten to the U.S. Supreme Court.

Sandefur said one of two things may happen in Arizona. Either the FDA may decide not to step in or prosecute anyone, or the FDA will step in. If the FDA takes action, this would establish a legal challenge that can’t be settled and would force the issue up to the Supreme Court, she said.

Bloomberg Intelligence Analyst Brian Rye also told me President Donald Trump’s nominee to head the FDA, Scott Gottlieb, “is likely to support relaxing the agency’s existing restrictions on communications between drugmakers and payers, both pre- and post-approval.

Read my full article here.

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