A funding reauthorization bill that regulates the Food and Drug Administration cleared a hurdle Wednesday when a Senate committee approved it.
The legislation, approved by the Health, Education, Labor and Pensions Committee, reauthorizes user fees that drug and medical device industries pay to the FDA. It also adds a new fee for companies that make generic medications, specifically allowing the government to collect $299 million each year in fees from the generic drug industry for four years.
If the bill passes, it also would allow FDA reviewers to speed up the clearance of products for rare disease. The language also calls for developing incentives for “development of new qualified infectious disease products (QIDPs) by providing an additional five years of market exclusivity.” That could be good news for nursing homes, where infectious diseases can be deadly to vulnerable seniors.
Congress has to send the bill to the president by Oct. 1. To read the HELP committee’s bill, click here.
