Congressmen Criticize FDA’s Approach to Off-label Concerns

Two House Republicans are accusing the FDA of shirking its responsibility when it comes to explaining the limits of off-label promotion, leaving it up to the courts to decide the matter for it.

In a pointed letter that took aim at both the FDA and HHS, top members of the House Energy and Commerce Committee said they were “perplexed by the agency’s unwillingness or inability to publicly clarify its current thinking on these issues in a coherent manner.”

Committee Chairman Fred Upton (R-Mich.) and Subcommittee on Health Chairman Joe Pitts (R-Pa.) note that the agency has not issued any guidance explaining how it will respond to the off-label promotion of prescription drugs in the wake of three high-profile court battles challenging the constitutionality of the FDA’s promotional regulations.