Political Quotes

“I ask unanimous consent that the following letter be printed in the Congressional Record. There being no objection, the material was ordered to be printed in the Record, as follows: U.S. Senate, March 14, 2019. Hon. Mitch McConnell, Senate Majority Leader, U.S. Senate, Washington, DC. Dear Leader McConnell, I am requesting to be consulted before the Senate enters into any unanimous consent agreements or time limitations regarding H.R. 269, the Over- the-Counter Drug Safety, Innovation, and Reform Act. I further request that this legislation not be incorporated into any larger legislative vehicles that the Senate as a whole may consider until the concerns I describe below are fully addressed. This legislation streamlines the outdated over-the-counter (OTC) drug approval process at the U.S. Food and Drug Administration (FDA)--a process originally developed in 1972. Specifically, the legislation allows the FDA to approve OTC versions of prescription drugs administratively, rather than going through the lengthy notice-and comment-rulemaking procedures under the Administrative Procedure Act. The legislation also encourages more innovation and investment in the OTC space by providing an 18-month market-exclusively component that rewards a return on investment for new OTC drugs. The 18-month market exclusivity period is crucial to creating a thriving OTC drug market; however, H.R.…”