A Murky Future for Off-label Promotion: Off-Label Bills Garner Minimal Traction in Congress

Further muddying the off-label waters is the fact that Congress has introduced several bills, attempting to legislate off-label use. Both bills were initially introduced as attachments to the FDA reauthorization bill, but when House Democrats resisted, both sponsors pulled the bills as attachments. On July 12, 2017, the Subcommittee on Health held a brief hearing on both bills, giving industry and others a chance to speak on off-label promotion.

In March 2017, the United States Food and Drug Administration (“FDA”) delayed a rule that would have expanded its ability to police off-label use for one year. With all of the litigation and the various attempts at regulations – at the federal, state and even city level – to clarify this space, it was inevitable that Congress would feel the need to step in.

While the healthcare debate raged in the Senate, the House of Representatives introduced two bills this Congressional session. Both bills were sponsored by Republicans: Representative Morgan Griffith (R-VA 9th District) introduced the Medical Product Communications Act and Representative Brett Guthrie (R-KY 2nd District) introduced the Pharmaceutical Information Exchange Act. While neither bill has gained much traction, a recent hearing held in the House Energy and Commerce Committee allowed a two-hour discussion on the bills and the challenges (and benefits) of current off-label restrictions.