WASHINGTON — Senator Ron Johnson (R-Wis.), chairman of the Senate Homeland Security and Governmental Affairs Committee, met with Food and Drug Administration (FDA) Commissioner Scott Gottlieb Tuesday to discuss implementation of S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017. Johnson had previously sent a letter to Gottlieb following remarks suggesting the FDA may need to issue regulations to “balance” the law’s requirements.
“I appreciated the opportunity to meet with FDA Commissioner Scott Gottlieb yesterday to discuss Right to Try. We agreed that the intent of the law is to increase individual patients’ ability to choose for themselves the treatment options they feel give them the best chance to survive given their individual condition. He committed to me that as the Food and Drug Administration (FDA) implements this law, the agency will do so in a way that maximizes access consistent with its intent.
“We discussed the complexity of the development, study, and production of new therapies, especially for rare and severe diseases. There are many risks facing the sponsor of a therapy under study and review, as well as legitimate reasons some sponsors may choose not to participate in Right to Try or the legacy Expanded Access program. These realities are why it is crucial that implementation encourages participation by assuring parties that the Right to Try law and the FDA’s interpretation of the law does not impose additional risk to drug development and approval.
“I look forward to working with Commissioner Gottlieb and his team to make sure Right to Try is ultimately successful and that patients with no other options obtain the hope and freedom the bill was designed to provide.”
Johnson’s letter to Commissioner Gottlieb on May 31, 2018 can be found here.