A bipartisan group of House Members introduced today 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. Under sequestration, the FDA is set to lose $85 million in user fees in fiscal year 2013 alone.
The authors of the bill, Reps. Anna G. Eshoo (D-Calif.), Leonard Lance (R-N.J.), Doris Matsui (D-Calif.) and Mike Rogers (R-Mich.), have grave concerns that the FDA will be unable to meet its Congressionally-mandated responsibilities unless its user fees are exempted from sequestration.
"It's extremely troubling that the FDA's industry-financed user fees are being sequestered. If the intent of sequestration is to limit public spending, withholding private monies is counterintuitive," said Eshoo, who serves as a senior member on the Energy and Commerce Committee. "Whether one agrees or disagrees with sequestration, I don't believe private dollars should be held hostage by the policy. It discourages investment in medical innovation and denies patients access to timely therapies."
"Passage of this important 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 and member of the Health Subcommittee.
"This legislation is essential to ensure that the FDA is able to fully achieve its performance targets in the clinical testing and approval of the innovative therapies that millions of people are hoping and waiting for. These patients, many of whom are battling deadly diseases, should not be deprived of potentially lifesaving therapies due to delays caused by political gamesmanship in Washington. It is my hope that we move quickly to pass this critical bill so the FDA can move forward with its mission of saving lives," said Matsui, a member of the Energy and Commerce Committee.
"It is critically important that industry-financed user fees are used for the purpose for which they were intended--preserving America's status as the world leader in medical innovation by ensuring an efficient and predictable review process for new medicines" said Rogers, senior member on the Energy and Commerce Committee. "Without these privately-funded user fees, the FDA would be unable to keep pace with the newest scientific discoveries, lengthening review times and seriously jeopardizing the time patients in the U.S. wait for lifesaving treatments."
The legislation is supported by PhRMA, AdvaMed, the Medical Device Manufacturers Association, California Healthcare Institute, 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, Rep. 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.