Earlier this month, Tennessee House Bill 2220 (substituted for Senate Bill 2361) (Tennessee Law) was enacted, which provides, “A pharmaceutical manufacturer or its representatives may engage in the truthful promotion of off-label uses.” The Tennessee Law is effective July 1, 2018. This law follows on the heels of “The Free Speech in Medicine Act” (Arizona Law) enacted last year in Arizona. Like the Tennessee Law, the Arizona Law states that, notwithstanding any other law, “…a pharmaceutical manufacturer or its representative may engage in the truthful promotion of an off-label use of a drug, biological or device.”

There are many similarities between the two laws. Both the Tennessee Law and Arizona Law:

  • Define “off-label” as the use of a United States Food and Drug Administration (FDA)-approved drug, biologic or device for a use not otherwise approved by the FDA;
  • Define “misbranding” under the definition in 21 U.S.C. § 352, or the state’s applicable misbranding law ( Code Ann. § 53-10-106; Ariz. Rev. Stat. Ann. § 32-1967);
  • Delineate that the new laws do not create any obligation on the part of a healthcare insurer, other third-party payor or other health plan sponsor to provide coverage for the cost of any off-label use of a drug, biologic or device;
  • Prohibits, notwithstanding any other law, officials and employees of the state from enforcing the state’s misbranding prohibition against, or otherwise prosecute, a pharmaceutical manufacturer or its representatives for the truthful promotion of an off-label use of a drug, biologic or device; and
  • Prohibits, notwithstanding any other law, applicable state licensing boards from revoking, failing to renew, or taking any other action against the license of a pharmaceutical manufacturer, its representative, healthcare institution, or physician solely on the basis of engaging in truthful promotion of an off-label use of a drug, biologic or device.

In the Arizona Law, “truthful promotion” is defined as, “…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.” “Truthful promotion” is not defined in the Tennessee law and it is difficult to predict how Tennessee state regulators will interpret this pivotal term.

It bears noting that despite these two laws, off-label promotion between pharmaceutical manufacturers and physicians is regulated by the FDA under its authority provided by the Food, Drug, and Cosmetic Act (FDCA). While a number of state legislatures have introduced similar off-label legislation, it remains unclear if additional states will enact such legislation or if the FDA will provide additional clarity regarding such communications.

Posted by Robert A. Paster