Bill introduced to protect FDA drug user fees from sequestration
WASHINGTON — Rep. Leonard Lance, R-N.J., on Wednesday announced he was teaming up with Rep. Anna Eshoo, D-Calif., to re-introduce the FDA Safety Over Sequestration Act, which exempts Food and Drug Administration user fees from sequestration.
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, the Congress leaders noted.
“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.”
"User fees for generic drugs are 100% industry-supported and applied to the shared priorities established by the historic Generic Drug User Fee Act," noted Ralph Neas, Generic Pharmaceuticals president and CEO. "These efforts include reducing the backlog of generic drug applications at FDA, enhancing safety, expediting access, and promoting transparency for high-quality and affordable generic drugs," he said. "Subjecting more than $300 million in annual generic drug industry user fees to sequestration puts these efforts at risk — the financial strain this would place on FDA is avoidable.”
“PhRMA remains deeply concerned about the impact of potential sequestration in the future on the FDA’s ability to fulfill its critical public health mission by fostering timely patient access to safe and effective new medicines and advancing regulatory science," added Bill Chin, EVP scientific and regulatory affairs Pharmaceutical Research and Manufacturers of America. “Prescription drug user fees cannot, by law, be used for any purpose other than to support FDA’s human drug review program. Their sequestration does not decrease the nation’s deficit, but only serves to exacerbate the severe budgetary constraints of a historically underfunded agency. This is detrimental to patients, regulatory science and public health.”
The bipartisan legislation seeks 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% 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. Congress has recently increased FDA user fees in addition to strengthening and improving the review process.