HHS Blocking FDA Off-label Policy: Congressmen
Republican leaders of the House Energy and Commerce Committee say they understand that FDA’s failure to publicly clarify its thinking on communication of truthful and non-misleading information on off-label uses of drugs and medical devices may be due to a disagreement between FDA and HHS leadership. In a 5/26 letter to HHS secretary Sylvia Burwell, committee leaders say that “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being on FDA’s guidance agenda since 2014, it is our understanding that HHS has not allowed FDA to issue its completed draft guidance addressing the scope of permissible “scientific exchange.”
The letter says that although comprehensive guidance will be a welcome step in the right direction, the committee members question whether non-binding policy statements can satisfy due process requirements. It notes that as part of the 21st Century Cures Act deliberations, the committee proposed legislation (draft attached to letter) to clarify key terms and concepts within the Federal Food, Drug, and Cosmetic Act to establish clearly defined ways that manufacturers could disseminate scientifically accurate information and preserve FDA’s approval standards for drugs and medical devices.
Committee members say they remain “ready and eager to help FDA develop a constitutionally sound path forward.” They say that the 21st Century Cures Act includes a requirement that FDA issue within 18 months of the bill enactment a draft guidance, which it now appears has already been sent to HHS for clearance.
“In addition,” the letter says, “the bill includes statutory changes clarifying how manufacturers can communicate healthcare economic information about their products to insurance companies and other similarly discerning entities in a slightly less restrictive manner. Nonetheless, the White House issue a statement of administration policy prior to 344 members of the House voting for the bill, asserting that this provision ‘could undermine regulatory standards by allowing unproven uses of therapies to be marketed to healthcare payors as though such uses had been proven safe and effective. The fact that such rhetorical ire was focused on such a common sense change was somewhat surprising, particularly given that the provision in question specifically requires a ‘conspicuous and prominent statement describing any material differences between the [information] and the [approved] labeling. It did however confirm our suspicions that HHS has become reflexively opposed to enabling FDA to make even minor policy changes in this space, despite their legal footing continuing to crumble. It also shows why it is becoming increasingly apparent that Congress must act.”