The Washington Legal Foundation is a heavy hitter in legal circles, especially on matters related to commercial free speech. The CHC contributed to a new legal backgrounder by its senior litigation counsel, Zac Morgan, who writes that if the FDA or HHS pursue a strategy of heavily restricting what companies can say in pharmaceutical direct-to-consumer (DTC) ads, they “will be inviting a serious constitutional challenge” based on Supreme Court precedents about what companies can say about their products.
How Does the FDA/HHS Likely Proceed
In its press releases on September 9th, the FDA announced a three-prong approach to limiting DTC Rx advertising: 1) stricter interpretation and enforcement of the 2023 CCN rules through untitled letters; 2) expanded oversight on Rx social media & telehealth ads which the FDA has focused to date on warning letters to telemarketing compounding pharmacies; and 3) removing the “adequate provision loophole” which effectively is intended to be a backdoor ‘de facto’ Rx ad ban. HHS has needed to pivot to a regulatory scheme as an executive order to outright ban Rx ads was blocked by the White House due to Supreme Court precedents that would have immediately brought a First Amendment legal challenge.
Let’s start in reverse order from above. Misnomered in the FDA September release, “adequate provision” is not a loophole created in 1997 guidance, but a core principle incorporated by Congress and the Food & Drug Administration in the 1960’s original rules that allows broadcast Rx ads for healthcare providers and consumers to include the major side effects and ‘don’t use if’ warnings. And it requires having the full list of risks at another accessible source, such as a website, 1-800 information line, medical journal or magazine, and print information with your healthcare provider or pharmacist. FDA’s “Consumer-Directed Broadcast Advertisements” regulatory guidance, finalized in 1999, only clarified and offered Q&As on the original rule.
It is more likely that the FDA is pursuing a “notice and comment” rulemaking that could be brought forward in the next few months. While FDA could take a more thoughtful approach to codify its recent stricter CCN enforcement, it currently appears that the Administration is less interested in grounded federal rulemaking than playing a “gotcha” game with FDA regulations shifting at the whim of HHS.
Expanded FDA enforcement into social media and telemarketing is another possible area for new regulations, but there are lingering questions of FDA’s authority over other digital channels outside of TV and radio, as well as whether FDA has jurisdiction over telemarketing compounding pharmacies and direct-to-patient platforms such as the anticipated Trump Rx site early next year.
The FDA could also attempt to remove or revise the clarifying DTC broadcast advertising guidance finalized in 1999, yet contrary to the claims made in the FDA’s September release, such an effort would not change the historical underlying statutes and regulations but would bring multiple paths into play for litigation. How ever the FDA proceeds on this issue, the legal commentary noted above has it right – any final rule on DTC Rx advertising will draw constitutional and legal challenges.
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