The government is serious about opioids. We can see that in the many big, headline-grabbing steps it is taking to confront the problem. We can also see it in a number of small, less well-known steps it has taken. These often unheralded actions are strong evidence that the government is thinking hard, thinking creatively, and thinking aggressively. We will discuss one of those actions here: the unleashing of the FTC into the opioid field.
To review, over a year ago, the Department of Health and Human Services declared the opioid crisis a public health emergency. Since then, numerous federal agencies have been enlisted to step up their efforts to address the emergency. We highlight just a few of the recent statements by the DOJ, the FDA, and the FTC that affirm their commitment to combat opioid drug abuses. This government-wide effort is necessary. As James M. Burnham, the Deputy Assistant Attorney General of the Department of Justice, recently reminded us, opioid drug overdoses claimed the lives of 49,000 Americans in 2017.
Among the many big steps that the government has taken to address the crisis is the recently enacted SUPPORT for Patients and Communities Act (the “SUPPORT Act”). The SUPPORT Act is a wide-ranging law that seeks to prevent and treat opioid abuse, as well as help people recover from their addictions. Contained in the SUPPORT Act is one of the little steps we mentioned above. Section 8023 of the SUPPORT Act penalizes unfair and deceptive acts or practices involving services or products that treat substance abuse. Importantly, Section 8023 grants the FTC authority to enforce this provision.
Congress’s decision to specifically allow the FTC to enforce Section 8023 is especially noteworthy because it overrides a decades-old agreement between the FTC and the FDA. Since 1974, the FTC and the FDA have operated under a Memorandum of Understanding (“MOU”) that outlined each agency’s responsibility and authority over prescription drugs. Perhaps to oversimplify, the MOU gave the FDA primary authority over prescription drug advertising, leaving the FTC to address non-prescription drug advertising. The SUPPORT Act changed all of that. Congress has effectively reallocated the agencies’ regulatory responsibilities by putting the FTC and the FDA on equal footing with respect to the advertising of prescription opioids.
The consequences of this change remain to be seen. Still, we note that unlike the FDA, the FTC has independent, civil law enforcement authority under the FTC Act. In contrast, the FDA must rely on the DOJ to enforce the Federal Food, Drug, and Cosmetic Act. Bringing the FTC to the fight is one more example of the government expanding its enforcement arsenal, an expansion we’ve noted before.
If you have questions about the SUPPORT Act, or any other information discussed in this blog post, the Venable Team is here to provide additional guidance.