Clock Ticks On Adding OTC Monograph Reform To FDA User Fees Bill
With Congress leaving Washington for Independence Day week and much of August, few days remain to consider adding to each chamber's reauthorization legislation language from Sens. Isakson and Casey's discussion draft for US OTC monograph reform and a user fee program to support FDA's work.
You may also be interested in...
FDA’s Aug. 23 webinar will update industry stakeholders on progress to modernize its OTC monograph program, but without user fee legislation, new performance goals will not take effect; stakeholders hold out hope a standalone OTC user fee bill could still progress in Congress.
First hearing in Sen. Alexander's committee was dominated by Democrat complaints about Obamacare repeal; now that there's an actual bill to criticize, the next one might have been even worse, but regardless of the reason, the postponement means innovator prices get to stay out of the spotlight once again.
One tier could provide two-year exclusivity, should FDA request clinical trials for new conditions or ingredients, under a US Senate discussion draft. Essentially stalled monograph process would be replaced by deadlines for FDA action in under two years.