WASHINGTON, DC - In light of recent litigation, House Energy and Commerce Committee leaders today sent a letter to the Department of Health and Human Services (HHS) questioning the U.S. Food and Drug Administration’s (FDA) current approach to regulating off-label communications. The letter, sent by full committee Chairman Fred Upton (R-MI) and Health Subcommittee Chairman Joseph Pitts (R-PA), also expressed a willingness from the committee to work with the agency to institute responsible policy solutions.
In the letter to HHS Secretary Sylvia Burwell, Upton and Pitts write, “We are writing to express our concerns about the Department of Health and Human Services’ (HHS) current position on the Food and Drug Administration’s (FDA) regulation of medical product manufacturer communications, including the proactive dissemination of truthful and non-misleading information that is outside the scope of a product’s FDA-approved labeling. … Recent litigation has raised significant questions about FDA’s authority to restrict such communication."
Upton and Pitts continue, “As FDA’s authorizing committee, we are increasingly perplexed by the agency’s unwillingness or inability to publicly clarify its current thinking on these issues in a coherent manner. If FDA continues to remain silent, settlement agreements will be the only means by which policy is formulated-and it will be in an ad hoc manner lacking any semblance of consistency and cohesiveness. It has come to the committee’s attention that such inaction may be the result of disagreements between FDA and HHS leadership. Specifically, despite being on FDA’s guidance agenda since 2014, it is our understanding that HHS has not allowed FDA to issue its completed draft guidance addressing the scope of permissible ‘scientific exchange.’ While comprehensive guidance would be a welcome step in the right direction, we still question whether non-binding policy statements would satisfy due process concerns."
The leaders conclude, “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."
