As we have previously covered, the Food and Drug Administration is in the midst of reevaluating its policy on off-label promotion of medical products—that is, promotion of drugs, medical devices, and biologics for uses not approved by FDA. However, on March 21, Arizona Governor Doug Ducey signed a bill into law that challenges FDA’s prohibitive stance on off-label promotion.
HB 2382, titled “The Free Speech in Medicine Act,” permits “a pharmaceutical manufacturer or its representative” to engage in “truthful promotion of an off-label use of a drug, biological product or device.” The brief, one-page piece of legislation protects pharmaceutical manufacturers from penalties under the Arizona law on misbranding. The law uses the same definition of “misbranding” as the federal definition in 21 U.S.C. 352. Under the law, companies may promote their products to physicians for uses not approved by FDA, as long as this promotion is “truthful.”
The Arizona law provides a definition of “truthful promotion”:
the sharing of information that is not misleading, not contrary to fact, and consistent with generally accepted scientific principles, between pharmaceutical manufacturers and licensed professionals who can prescribe medication within the provider’s scope of practice.
Here, notably, the statute limits promotion to communication with healthcare professionals, and it provides no detail on what is sufficient evidence to constitute “truthful” information (i.e., the weight of clinical evidence needed).
The Arizona law has passed at a moment of uncertainty for companies looking to FDA for guidance. FDA held a November hearing on off-label promotion, then reopened the docket and issued a memorandum in January (which we have written about) to provide an overview of the agency’s considerations on the issue. In the January memo, FDA reiterated that it views its role as vital in regulating off-label promotion.
- Practically, Arizona’s new law seems to be largely symbolic. Though the law removes Arizona’s state penalties for off-label promotion, federal penalties have not changed.
- The law only protects communication between pharmaceutical manufacturers and healthcare providers—the law does not protect direct-to-consumer off-label promotion.
- Arizona’s law is the first state initiative to pass, but other states may follow suit. The Goldwater Institute, whose vice president authored the model language upon which the law is based, has stated that the Institute “is pursuing several additional healthcare policies to remove barriers that prevent healthcare professionals from providing the care they are trained to give.”
- Because of federal preemption, manufacturers cannot rely on the Arizona law as a basis for disregarding the current federal law.
- However, the passage of Arizona’s law brings even more attention, and perhaps pressure, to FDA’s evaluation of its policy on off-label promotion. FDA will still be ultimately responsible for any substantive change to off-label promotion, but Arizona’s law is yet another reminder for FDA that others are not sitting idly by while the agency decides on its next steps.
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