On the recordMay 22, 2018
Before giving my remarks, I include in the Record a statement by Senator Johnson explaining the intent of S. 204. Statement of Legislative Intent (By Sen. Ron Johnson on S. 204 (as considered by the House of Representatives)) In a recent article about pending right to try legislation, FDA Commissioner Scott Gottlieb was quoted as saying: ``In terms of making sure that it balances [access to experimental drugs] against appropriate patient protections . . . with [S. 204], we'd have to do a little bit more . . . in guidance and perhaps in regulation to achieve some of those goals, and I think those are the goals that Congress wants us to achieve.'' The article went on to quote Commissioner Gottlieb as saying: ``We felt that there were certain aspects of [S. 204] that could be modified to build in additional patient protections, but if you weren't able to do that legislatively, that there [was] a pathway by which you do that administratively and still remain consistent with the letter and the spirit of this law.'' In response to this article, Commissioner Gottlieb tweeted the ``FDA . . . stands ready to implement [right to try] in a way consistent with the intent of Congress.'' As S. 204's primary author and lead sponsor, I want to make this legislation's intent absolutely clear and remove any ambiguity that the FDA could use to implement right to try in a way contrary to its aim. S.…
