User Fee Bills: After Mark-ups, How Will House And Senate Reconcile Differences?
House and Senate committee user fee bill mark-ups approaching, but drafts have differences in drug shortage, supply chain security and other proposed policy changes to reconcile.
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FDA user fee reauthorization eliminates limits on waivers, which may ease the burden on FDA to fill open seats on its advisory committees. Vacancy rates have been as high as 24% in FY 2012.
The Utah Republican’s draft bill would encourage industry to increase its capacity to manufacture sterile injectable drug products by providing higher reimbursement rates and exclusivity incentives. House Republicans continue to pursue economic options, but time and jurisdictional factors could work against such measures to address shortages.
While drug development incentives will increase federal health care program spending, other provisions designed to allow lower-cost drugs on the market faster are expected to reduce costs.