Tennessee becomes the second state in the country permitting pharmaceutical companies, including its representatives, to engage in truthful promotion of off-label uses (the first being Arizona in 2017; see our Policy & Medicine article here). On May 3rd, Governor Bill Haslam (R) signed House Bill 2220 (companion Senate Bill 2361) into law (Public Chapter No. 893). Similar to Arizona’s legislation, Tennessee’s legislature unanimously passed their respective bills (House: Ayes 94, Nays 0; Senate: Ayes 25, Nays 0). The law becomes effective on July 1, 2018.
Tennessee’s law defines “off-label” as “the use of an United States Food and Drug Administration (“FDA”)-approved drug, biological product, or device other than the use or uses approved by the FDA.” Health insurance entities, other third-party payers, or other health plan sponsors, may, but are not required to provide coverage for an off- label treatment. Provided manufacturers, including representatives, engage in the truthful promotion of off-label uses, the law prevents
(1) state officials, employees, or agents of the state from prosecuting either under the state’s misbranding provisions, and
(2) state regulatory boards (e.g., Board of Pharmacy, Board of Medicine, etc.) from taking any action against either (i.e., revoking, failing, renewing a license).
The biggest difference between the Arizona and Tennessee laws is that Tennessee’s law does not define “truthful promotion” (see Ariz. Rev. Stat. Ann. § 32-1997(E)(4)). Regardless, most companies will likely forgo engaging in truthful off-label promotion until the FDA issues clear guidelines in this area.
Over a year ago, former FDA Commissioner Dr. Robert Califf issued a press release announcing the issuance of two draft guidance documents and a memorandum related to “[its] rules and policies relating to firm communications regarding unapproved uses of approved or cleared medical products, including a discussion of First Amendment considerations” (see FDA Press Release here).
Despite the Memorandum doubling-down on the Agency’s position of generally prohibiting manufacturers from engaging in off-label promotion, there appears to be pressure mounting within the Agency to lift the ban. Recently at the FDAnews Off-Label Communication: Top Tips for Compliance Conference, then-Deputy Assistant Attorney General Ethan P. Davis provided remarks reaffirming the Department of Justice’s position on off-label promotion. He stated “[DOJ] will vigorously investigate and prosecute firms that make false or misleading statements to prescribers or patients.” He provided several examples of recent enforcement actions targeting off-label promotion (read the DOJ press releases here, here, and here) that were symbolic of companies engaging in practices that could potentially pose a threat to patient health or safety. The silver-lining in the remarks is that companies that engage in truthful promotion of off-label uses may not trigger enforcement action unless the speech at issue is false or misleading or the off-label use caused injury or harm.
This year alone, at least five states (Colorado, Missouri, Mississippi, and Wyoming) including Tennessee, have introduced similar legislation. Without clear guidance from federal regulators, states and federal legislatures will continue introducing legislation (see recent journal article from PLoS Med for support).
If you’re a subscriber to Policy & Medicine’s Life Science Compliance Update, you can find more articles written about off-label promotion here.