Eshoo, Lance Bill to Bolster Development of Lifesaving Drugs Clears Major Committee Hurdle

Press Release

Congresswoman Anna G. Eshoo (D-Calif.) and Congressman Leonard Lance (R-N.J.) released the following statements today after bipartisan legislation they authored was unanimously voted out of the Energy and Commerce Committee as part of the 21st Century Cures Act. The lawmakers' legislation, the FDA Safety Over Sequestration Act (FDA SOS Act), exempts Food and Drug Administration (FDA) user fees from sequestration. FDA user fees are paid by industry to hire staff at the agency to process applications for new drugs and medical devices. In the event of another sequester, such as the budget sequestration of 2013, the FDA could lose tens of millions of dollars in user fees, preventing it from meeting its Congressionally-mandated responsibilities and leaving patients without lifesaving therapies.

"Today the Energy and Commerce Committee acted unanimously on bipartisan legislation to improve patient safety and the development of lifesaving therapies," said Eshoo, who serves as a senior member on the Energy and Commerce Committee. "I couldn't be more pleased to see this legislation advance."

"Sequestering FDA user fees is irresponsible public policy, so I am pleased to see action to correct this issue pass out of the Energy and Commerce Committee as part of the 21st Century Cures Initiative," said Lance, who is a member of the Energy and Commerce Health Subcommittee. "Federal health agencies must have the critical tools and resources to approve new medicines and medical devices that are safe and effective. FDA user fees are private dollars earmarked specifically for patients, public health and medical innovation and I am proud to have worked with my friend and colleague Congresswoman Eshoo on this issue."

Eshoo and Lance have concerns that a repeat of the 2013 sequester could reduce not only the FDA's budget, it would also reduce industry-financed user fees to the agency. While manufacturers were paying the full cost of user fees (as mandated by statute), a significant portion of those funds were not distributed to the agency. After formal requests to Congressional appropriators from Eshoo and Lance, the funds were ultimately restored to the agency, but not without detrimental short and long-term effects. Another sequester could have compounding and devastating effects on patient safety.

"The FDA's user fees are 100 percent private sector dollars," Eshoo continued. "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 potentially lifesaving therapies."

Background

The FDA SOS Act is supported by PhRMA, AdvaMed, the Medical Device Manufacturers Association, the California Life Sciences Association, Leukemia Lymphoma Society, Gilead, Genentech, Patient Services Inc., and the National Health Council.

FDA user fees are designed to supplement Congressional appropriations and help to expedite the approval process for new medical therapies. An efficient FDA encourages innovation, promotes economic growth, and improved the outcomes of patients. Pharmaceutical user fees were first introduced in 1992, in response to dangerously slow approval times for new drugs. After witnessing the success of drug user fees, Congresswoman Eshoo wrote legislation to create medical device user fees which have been in effect since 2002. These user fees have come to represent a vital collaboration between the FDA and industry. Just last year, Congress passed legislation to renew and increase FDA user fees in return for a strengthened and improved review process.

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