Leaders of the House Energy and Commerce Committee, including Chairman Fred Upton (R–MI) and Health Subcommittee Chairman Joseph Pitts (R–PA) have written a letter questioning the off-label regulations of the U.S. Food and Drug Administration (FDA).
Upton and Pitts sent a letter to the Department of Health and Human Services (HHS) to request answers about how the FDA communicates its off-label authority.
“We are writing to express our concerns about the Department of Health and Human Services’ current position on the Food and Drug Administration’s 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,” they said in the letter. "Recent litigation has raised significant questions about FDA’s authority to restrict such communication.”
Upton and Pitts stated that they are willing to collaborate with the FDA and the committee in order to create responsible policy solutions.
“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,” they said. “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being on FDA’s guidance agenda since 2014, it is our understanding that HHS has not allowed FDA to issue its completed draft guidance addressing the scope of permissible ‘scientific exchange.’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.”
Upton and Pitts hope that the FDA will be open to updating the laws.
“The committee is open to considering alternative approaches to address such an important issue,” they said. “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.”
