Today, Senators Richard Burr (R-NC) and Tom Coburn (R-OK) released the following statement on the GAO oversight report (GAO-12-418) released today. Senator Burr presented this report to fellow members of the Senate HELP Committee at a hearing this morning.
"The GAO oversight report released today confirms a disturbing trend: the FDA is taking longer and longer to make final decisions on life-saving medical devices. GAO also confirms the FDA is not meeting some of its performance goals.
Patients and taxpayers care about how long it takes for safe and effective life-saving products to reach them. Unfortunately, the GAO report highlights that red-tape at the FDA is making it more difficult for life-improving devices to reach patients as quickly as possible.
This report makes clear that reporting only on the user fee performance goals negotiated by industry and the FDA does not paint a full picture of FDA's performance. GAO's report shows that FDA's final decisions on devices are taking longer due to more review cycles and requests for additional information.
Patients rely upon FDA to make sound medical decisions in as timely a manner as possible. Increasing regulatory uncertainty and unnecessary delays are stifling investments in the development of life-saving medical products. If Congress fails to ensure consistent oversight and transparency at FDA, we risk continuing to drive medical innovation and job creation overseas and jeopardizing American patients' access to the most cutting-edge medical therapies and advances."