Administration Drags Feet on Off-Label Changes


Growing Chorus of Pleas to Modernize FDA’s Position on Off-Label Communications, But Concerns Grow that Administration Isn’t Serious About Timely Resolution

At the end of August, the FDA announced plans to hold a public hearing in November regarding off-label communications. The agency’s willingness to publicly discuss these issues is a welcome yet long overdue development, and the recent string of FDA losses in the courts should expedite – not further delay – clarifying the rules of the road.

“This announcement comes in the wake of increased pressure from lawmakers, public interest groups, and regulated industry for FDA to issue guidance or propose regulatory changes to address recent litigation clarifying commercial speech protections for pharmaceutical and medical devices manufacturers under the First Amendment,” wrote The National Law Review.

The House Energy and Commerce Committee has led the charge for certainty by proposing statutory clarifications last year and writing to HHS on the issue at the end of May 2016, after FDA lost several high-profile legal battles. Committee leaders declared a willingness to work together with the agency in finding responsible, Constitutionally-sound solutions and hopefully avoid continued litigation.

“The committee is open to considering alternative approaches to address such an important issue. However, Congress needs a willing partner that will engage seriously in modernizing law to reflect the intersection of off-label use and 21st century medicine,” wrote Energy and Commerce Committee Chairman Fred Upton (R-MI) and Health Subcommittee Chairman Joseph Pitts (R-PA).

Unfortunately, the reply received by Chairman Pitts over three months later was not serious. This administration has claimed to be “engaging in a comprehensive review of its regulatory framework” and working on draft guidance documents since at least 2014.

So why hold a public hearing? The National Law Review suggests FDA is continuing to kick the can down the road, writing, “While FDA’s notice and request for comments is a step in the right direction, it likely signals a further delay in the issuance of guidance that is needed to bring greater clarity to the currently unsettled regulatory framework for FDA’s oversight of manufacturers’ off-label communications, and a punting of these important decisions to the next administration.”

Let’s end the continued delays and pursue thoughtful, Constitutionally-sound solutions that will provide certainty for the future.


Health (114th Congress)