WASHINGTON — Vice President Mike Pence publicly threw his support behind efforts to help terminally ill patients access experimental treatments in a Thursday morning tweet. “Let’s get this DONE,” Pence said about the “right-to-try” legislation currently stalled in Congress, citing a meeting earlier this week with Food and Drug Administration Commissioner Scott Gottlieb.
Yesterday I met with @SGottliebFDA on the importance of passing a Right to Try law. It's about restoring hope and giving patients with life threatening diseases a fighting chance. Let's get this DONE.
— Vice President Mike Pence (@VP) January 18, 2018
Pence, a longtime advocate of right-to-try legislation, has been working with his staff and several lawmakers who support the measures to pressure leaders in the House of Representatives to act on the issue early this year, several members have confirmed to STAT. The Senate passed legislation, from Sens. Ron Johnson (R-Wis.) and Joe Donnelly (D-Ind.), last fall.
The effort has since stalled in the House, thanks in part to concerns from Gottlieb. He suggested at an October hearing on the issue that lawmakers should significantly limit the scope of the legislation to avoid undermining the FDA’s authority over the drug approval process. Pharmaceutical companies, too, have pushed back on the legislation out of concern that providing experimental treatments might jeopardize their drug approval applications.
A spokeswoman for the FDA said Gottlieb met with Pence and members of Congress in the Capitol “to discuss how to advance this measure in a way that protects patients and provides them with the potentially lifesaving opportunities they deserve.”
Rep. Greg Walden (R-Ore.), who chairs the Energy and Commerce Committee that has jurisdiction over the bill, has not yet said whether his committee will move the legislation or when. When STAT asked last week whether he had plans to mark up the bill, Walden ducked into a part of the Capitol that is off limits to reporters. He confirmed that his staff, too, had heard from Pence’s staff on the issue.
Supporters of right to try have pushed for federal legislation on the topic to bar FDA and other agencies from intruding on the more than 30 existing state laws that already allow some patients access to experimental treatments. They say patients deserve a chance to try whatever treatment they can.
Opponents point out that the FDA itself already has a pathway for granting expedited access to treatment to patients with terminal illness. It grants many of those requests in a short time frame.