Howard Sklamberg Quoted by POLITICO on Possible Change to FDA Enforcement Efforts

POLITICO’s weekly “Prescription Pulse” has quoted Akin Gump health partner Howard Sklamberg discussing a possible change in the way the Food and Drug Administration (FDA) uses guidance documents as part of its enforcement work.

POLITICO notes that the FDA often uses guidance instead of formal regulations to outline certain expectations, but a new memo from the Justice Department says FDA cannot use its enforcement authority to convert agency guidance documents into binding rules or use noncompliance with guidance as a basis for proving violation of law.

The article reports this could cause problems for FDA since it often cites guidance in warning letters to companies that violate manufacturing requirements or advertising rules. It could also lead to a closer examination of whether FDA’s guidances are overreaching by creating obligations not required by law.

“Many federal agencies, including FDA, cite guidances in their compliance actions,” said Sklamberg, a former deputy commissioner for global regulatory operations and policy at FDA. “Some in regulated industry may examine whether a particular guidance oversteps into an area where it is creating binding obligations.”