Lance, Eshoo Want No Cuts to Health Innovation
WASHINGTON, D.C.— 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 paid entirely by companies in the industry to help speed up the approval of safe and effective drugs and devices. These funds are not taxpayers dollars and the Lance-Eshoo effort will make sure these funds keep going toward health innovation.
“Millions of Americans are counting on the medicines and devices currently in the FDA’s approval pipeline. We need this process moving and any effort to divert private funding from this effort must be stopped. FDA user fees support a system that helps keep innovations safe and effective. Too many life-saving innovations and therapies are needlessly compromised by the short-sighted decision to sequester these funds. I’m proud to again partner with Congresswoman Eshoo to prevent this from happening,” said Lance, a member of the Energy and Commerce Committee's Subcommittee on Health.
“The FDA’s user fees are 100 percent private sector dollars that are used specifically for lifesaving drugs and devices,” said Congresswoman Eshoo. “If the intent of sequestration is to limit public spending, withholding private monies is counterintuitive. Whether one agrees or disagrees with sequestration, private dollars should not be held hostage by the policy. It discourages investment in medical innovation and denies patients access to timely and lifesaving therapies. It’s critical now more than ever that we take steps to protect these private sector dollars. If Congress fails to vote on a new budget agreement, sequestration will return full force in the next fiscal year, putting these private sector dollars at risk,” said Eshoo, a member of the Energy and Commerce Committee's Subcommittee on Health.
The bipartisan team has successfully led the effort in the U.S. House in preventing sequester of FDA user fees, arguing against an Obama Administration decision to curtail the private dollars. Lance and Eshoo, through legislation and letter writing, have made the case that since these are private funds and not public spending, budget restraints should not apply. While they have been successful in previous fiscal years, this legislation would make a fix permanent. Sequestering these funds hinders the agency’s ability to meet congressionally-mandated responsibilities while putting patient safety at risk. 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.
“User fees are intended to ensure that FDA is equipped to evaluate new medicines and medical devices efficiently so that new treatments and cures can be delivered to patients as quickly and safely as possible. Congressman Lance is recognized for his leadership and commitment to protecting patient access to these life-saving treatments while preserving the innovation environment critical to discovering new medical advances,” said Dean J. Paranicas, President and CEO of the HealthCare Institute of New Jersey.
“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.