Arizona Law Puts Pressure on FDA to Change Off-Label Policies

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By Bronwyn Mixter

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.

Protecting Free Speech

The purpose of the legislation is “to protect free speech rights,” Christina Sandefur, executive vice president of the Goldwater Institute and the person who drafted the legislation, told Bloomberg BNA March 31.

While doctors are allowed to prescribe treatments off-label, pharmaceutical companies aren’t allowed to share information about those treatments, she said. “This is a free speech violation.”

Sandefur said 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.

“While federal law does preempt state law, a federal law that’s unconstitutional doesn’t,” Sandefur said.

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.

“Hopefully lawmakers in other states will follow suit,” Sandefur said. The Arizona law passed unanimously and this shows that “people recognize how important this is for patients.”

The Goldwater Institute also has pushed for states to enact “right to try” laws, which have now been adopted in 33 states. These laws allow terminally ill patients to get access to treatments that are being studied in clinical trials but haven’t yet been approved by the FDA.

Federal Law Preemption

Little will change for off-label communications until the FDA modifies its policies, according to sources contacted by Bloomberg BNA.

“The state law can effectively remove state penalties, and that’s what it’s done. But it doesn’t touch the federal requirements. They remain in place and the law of the land,” Bradley Merrill Thompson, a Washington-based health-care attorney with Epstein Becker & Green PC, told Bloomberg BNA in a March 29 email. “This really seems more of a symbolic act, than anything with practical effect.”

Deborah M. Shelton, a partner in the FDA Practice Group of McCarter & English in Washington, also told Bloomberg BNA in an email, “while this state-law approach helps to continue to shine a spotlight on the overarching need for greater flexibility in manufacturer’s medical product communications with health-care providers, it is not any sort of game-changer from a substantive standpoint.”

“This sort of state approach may help to constrain those going forward in a specific state with this type of law, but it is FDA that has the significant authority under federal law to regulate most manufacturer communications,” Shelton said. “Thus, it remains of critical importance that FDA modernize its regulatory framework governing product communications, separate and apart from whatever limited relief state law may provide. Without FDA acting as the change agent, whether through a federal legislative mandate or by its own regulations, the current environment of significant uncertainty and extensive litigation will continue.”

Thompson and Shelton are both Bloomberg BNA advisory board members.

A Pharmaceutical Research and Manufacturers of America (PhRMA) spokeswoman told Bloomberg BNA in a March 29 email that PhRMA didn’t take a position on Arizona’s legislation. “Our companies follow federal FDA regulations and laws on off-label promotion of medicines,” she said.

Will FDA Change Its Policies?

Bloomberg Intelligence Analyst Brian Rye told Bloomberg BNA in an email “the FDA does dictate off-label promotion, but it’s worth noting that they’re re-examining their policies in the wake of some legal decisions suggesting that a prohibition on truthful discussions may have First Amendment implications.” For example, the FDA held a public meeting in November 2016 to seek stakeholder input on off-label promotion.

Rye said 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.”

John Kamp, director of the Coalition for Healthcare Communication, told Bloomberg BNA in a March 30 email, “the Goldwater Institute and Arizona clearly have the policy right. Truthful off-label information from drug sponsors helps doctors and patients know what is needed to make appropriate treatment decisions.”

“But, according to the law of preemption, these are FDA, not state, policy decisions,” Kamp said.

Kamp said he’s optimistic that Gottlieb “will create rules that make such information sharing the law of the land.” The Coalition for Healthcare Communication, whose members include media, health-care and other organizations, promotes the free exchange of scientific and medical information.

The FDA declined to comment on the Arizona law.

What About Device Companies?

The Arizona law says drug manufacturers can engage in “truthful promotion of an off-label use of a drug, biological product or device.” But it doesn’t say medical device companies also can engage in off-label promotion.

“This is a very odd law,” Epstein Becker & Green’s Thompson told Bloomberg BNA. “For some reason, it only empowers pharmaceutical companies to engage in this off label promotion of drugs or medical devices. It does not allow a medical device manufacturer to do likewise.”

Thompson said, “To me, that’s a constitutional flaw in the Arizona law because there has to be a rational basis to distinguish among speakers when it comes to First Amendment rights, and there would not seem to be a rational basis to distinguish between pharmaceutical and medical device speakers.”

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

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