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An FDA Memo addressing First Amendment legal issues regarding off-label use of medical products falls short of the necessary clarity, write Jamie Kendall and Alexandra Schulz.
Perhaps it was wishful thinking. Did the industry believe that the FDA would wave its wand and provide clarity on the topic of manufacturer communications regarding unapproved uses of approved or cleared medical products? Apparently, yes.
In response to numerous comments made regarding First Amendment legal issues surrounding off-label uses of medical products at a public hearing held by FDA back in November 2016, the agency issued a draft 63-page Memorandum (the Memo)(1), which at first blush leads readers to believe that the Memo will address such constitutional issues associated with off-label communications. Constitutional issues which the industry has and continues to patiently wait for the FDA to opine upon from its perspective, particularly given recent legal developments that call into question the agency’s authority. However, this Memo does very little-if anything at all-to change FDA’s previously articulated positions on the current regulatory framework and outright dismissal of related First Amendment challenges.
In what appears to be a preemptive attack against First Amendment challenges to the current regulatory framework, FDA advances ways in which its premarket review of medical products for safety and efficacy advances public interest needs in comparison to off-label communications. FDA details seven ways in which its regulatory framework meets those needs, while acknowledging only two ways off-label communications achieve the same objective. The agency then undermines the two advances of off-label communications, stating that off-label uses are only truly beneficial to patients where there are no proven treatments or to patients that have exhausted all available approved treatment options. Shockingly, in doing so, FDA scorns patients who may benefit from off-label uses of medical products due to other circumstances and the professional medical judgment of such treating physicians.
Any remaining industry hopes that FDA would provide meaningful insight regarding off-label uses of approved drugs are quickly dashed in FDA’s discussion of First Amendment considerations. In an interesting twist, the agency not only advances its current regulatory framework but does so by recycling tired arguments industry and other interested parties are accustomed to. Rather than providing new commentary addressing public hearing comments on the Second Circuit’s landmark decision against the FDA in Caronia v. United States (2), FDA attempts to limit the impact by arguing that under Caronia, the agency is still permitted to utilize a company’s promotional speech of off-label indications as evidence of intent to misbrand the medical product (3).
This argument is not as availing as FDA suggests and is weakened by the fact that the Second Circuit assumed without deciding that honest speech could be used as evidence of illicit intent to misbrand a drug (4). FDA then sidesteps Caronia’s constitutional implications by arguing that the opinion is based on faulty analyses as it ignored “[m]ultiple components of public health interests advanced by FDA Authorities and FDA’s implementation approach.”(5)
Even less convincing is the agency’s defense of its prohibition and enforcement of company off-label communications in light of Sorrel v. IMS Health Inc. (6) FDA dismisses strict scrutiny challenges under Sorrel based on company off-label speaker- and content-based speech restrictions because such restrictions are “necessary…as part of reasonable government regulation of particular industries in the interest of greater public good.” (7) Such rhetoric seems unconvincing. as a similar argument was rejected by the Second Circuit in Caronia (8).
To further support its proposition that FDA’s prohibitions of firm off-label communications is not more burdensome than necessary to further its government interests in protecting public health, FDA examines and outright rejects 11 alternative methods for regulating off-label speech. These alternatives range from a blanket universal prohibition on the use and/or prescribing of medical products for off-label uses, to the wholesale authorization for companies to communicate off-label uses with appropriate warnings and disclosure that such use is off-label (9).
Functionally, this list is self-serving, as it only reinforces FDA’s premarket regulatory review framework as the only method that advances all public health interests and purportedly does not raise First Amendment issues. The agency then provides an appendix of examples where unapproved uses have caused patient harm and studies demonstrating the same. Such inclusions, particularly references to patient harm, are far from persuasive, considering these types of examples were ineffective in the past (10).
It remains unclear whether the recent changing of the guard in the White House will directly or indirectly influence FDA’s position on this issue. However, one thing is for sure. Based upon this Memo, it is apparent that FDA intentions are to maintain the status quo regarding the agency’s position on the topic-and may be going through the motions of a public comment period to appease increasing congressional and political pressures to act on this topic.
Jamie Kendall is Principal and Managing Partner of The Kendall Law Firm PC. She can be reached at firstname.lastname@example.org. Alexandra Schulz is Associate at the Kendall Law Firm PC. She can be reached at email@example.com.
1. Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products, 2 Fed. Reg. 6367, 6368 (Jan. 19, 2017).
2. 703 F.3d 149 (2d Cir. 2012).
3. Memo at 22.
4. Caronia at 169.
5. Memo at 23.
6.131 S. Ct. 2653 (2011).
7. Memo at 24-25.
8. Marcia M. Bouumil, et. al., Off-Label Marketing of Pharmaceutical Products in the Wake of United States v. Caronia and United States v. Harkonen, 9 J. Health & Biomedical L. 385, 419 (2014).
9. Memo at 26-34.
10. Caronia v. United States, 703 F.3d 149, 168 (2d Cir. 2012).