Group seeks more funds for FDA drug approvals

Group seeks more funds for FDA drug approvals
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A leading research advocacy group is calling on lawmakers to increase funding for the Food and Drug Administration. 

Research America, a coalition of universities, businesses and nonprofits that encourages funding for medical research, is pushing for at least $2.8 billion in funding for the FDA next year, an increase of roughly $200 million

The group sent a letter on Wednesday making the request to the chairmen and ranking members of the relevant appropriations subcommittees in each chamber.

“A quarter of all consumer spending is on FDA-regulated products,” the letter states. “We expect the FDA to assure that these products meet the high standards Americans deserve, and, because lives may hang in the balance, to do so as quickly as possible. The FDA needs adequate resources to meet those expectations. The stakes are high.”

The requested increase comes as Congress looks at changes to speed up the FDA’s approval of new drugs. 

The 21st Century Cures Act, which passed the House in July, encourages the use of “real world” observational effects of drugs rather than more rigorous clinical trials. It also encourages the use of preliminary measures known as biomarkers instead of waiting for the definitive results of a trial.

Democrats argued that with the new responsibilities, the FDA needs more funding; the Cures bill would include $110 million per year in new money for the agency. 

The Senate is currently working on its own version of the bill and haggling over how much funding to give the FDA and the National Institutes of Health.  

The Senate health committee will also consider President Obama’s nominee for FDA commissioner, Robert Califf, on Tuesday.