House Appropriators Propose OTC Monograph User Fee In FDA Budget
Nearly $263.4m in additional funding compared to previous fiscal year's total allocated to FDA in the House appropriations bill. More than 70% of increase, about $185.3m, would be in non-user fees or budget authority and $78.1m in would come from user fee revenue. Bill identifies an additional user fee program for agency in the event Congress passes legislation to overhaul FDA's OTC drug monograph process.
You may also be interested in...
Senate's Over-the-Counter Monograph Safety, Innovation, and Reform Act goes next for consideration by House, which has had a bill by the same title on its floor for a vote since it was passed by Energy and Commerce Committee in late June.
"We believe that we're going to get this done," but "it's possible that ... language authorizing the collection of user fees is not included in this year's appropriation legislation," says Sen. Bob Casey during HELP Committee's confirmation hearing for FDA commissioner nominee Stephen Hahn.
Instruction in Appropriations Committee report on FY 2020 spending bill garners support from some stakeholders while others say setting a safe level of CBD's use in non-drug products should come first. Senate appropriators endorses FDA policy that regulations allowing sales of CBD non-drug products "not discourage the development of new drugs."