Lance Bill To Protect Innovation From Sequestration

Press Release

Congressman Leonard Lance (NJ-07) today announced he was teaming up with Congresswoman Anna Eshoo (CA-18) to re-introduce the FDA Safety Over Sequestration Act, or FDA SOS Act, which exempts Food and Drug Administration (FDA) user fees from sequestration. FDA user fees are 100 percent industry-financed and are used specifically for the approval of safe and effective drugs and devices. The bipartisan team has led the effort in calling for an immediate fix to reverse the sequester of FDA user fees, arguing the intent of sequestration was to curtail public spending, not private dollars spent on medical innovation. Doing so hinders the agency's ability to meet congressionally-mandated responsibilities while putting patient safety at risk.

"Passage of this important bipartisan legislation is vital to protecting the FDA's access to industry user fees. These resources 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. "Too many life-saving innovations and therapies are needlessly compromised by the short-sighted decision to sequester these funds."

"New Jersey's biopharmaceutical and medical technology companies applaud Congressman Lance for his leadership in ensuring that industry paid user fees collected by the Food and Drug Administration (FDA) will be available to evaluate new medicines and medical devices that will benefit patients in the United States," said Dean J. Paranicas, President and CEO of the HealthCare Institute of New Jersey.

The bipartisan duo seek to protect the FDA user fees which are 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 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, Medical Device Manufacturers Association, California Healthcare Institute, AdvaMed, Leukemia Lymphoma Society, Gilead, Genentech, Patient Services Inc., National Health Council, and the American Cancer Society Action Network.

"The FDA user fees are critical to ensuring timely patient access to life-saving medicines and medical devices. We cannot have the life science sector, a major economic engine for New Jersey, challenged by these cuts. We must protect this program from the sequester and allow the FDA to fulfill its critical public health mission," concluded Lance.

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