WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), announced a hearing for Wednesday, September 13, 2017, at 10:15 a.m. in room 2322 of the Rayburn House Office Building. The hearing is entitled, “Modernizing FDA’s Regulation of Over-the-Counter Drugs.”
#SubHealth will examine draft legislation to establish an over-the-counter (OTC) monograph user fee program at the Food and Drug Administration (FDA). The hearing follows the successful five-year reauthorization of several of FDA’s critical medical product user fee programs.
“The process of bringing a new OTC monograph drug product to market is outdated and in need of reform,” said Chairman Burgess. “The committee will hear from FDA and stakeholders about a proposed regulatory framework that will bring low cost medicines to patients and consumers safely and more efficiently.”
The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted.