Congressman Leonard Lance (NJ-07) today announced the introduction of bipartisan legislation that would exempt approximately $1 billion in annual fees that drug and device companies pay the U.S. to review new products from federal budget cuts.
The "FDA Safety Over Sequestration Act," or "FDA SOS Act," is authored by Lance and U.S. Reps. Anna G. Eshoo (D-Calif.), Doris Matsui (D-Calif.) and Mike Rogers (R-Mich.).
"Passage of this important bipartisan legislation to protect the FDA's access to industry user fees will help ensure that millions of Americans will continue to benefit from medicines and medical devices that are safe and effective," said Lance, a member of the Energy and Commerce Committee's Subcommittee on Health.
The FDA user fee program is designed specifically for the approval of drugs and medical devices. The user fees are industry-financed and account for roughly 35 percent of the FDA's budget. Under sequestration, the FDA is prohibited from collecting approximately $85 million in user fees in fiscal year 2013 or more than $1 billion over a five-year period, according to the non-partisan Congressional Budget Office (CBO). Congress has recently increased FDA user fees in addition to strengthening and improving the review process.
The legislation is supported by the HealthCare Institute of New Jersey, AdvaMed, Medical Device Manufacturers Association, California Healthcare Institute, Leukemia Lymphoma Society, Gilead, Genentech, Patient Services Inc., National Health Council, and the American Cancer Society Action Network.
"The FDA user fee program is critical in ensuring timely patient access to life-saving medicines and medical devices. Protecting this program from the congressional sequester will allow the FDA to fulfill its critical public health mission," concluded Lance.