On the recordMarch 14, 2019
Mr. President, 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 This legislation streamlines the outdated over-the-counter (OTC) drug approval process at the U.S. Food and Drug Administration (FDA)--a process originally developed in 1972.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.…
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