Republican Sens. Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) urged Congress to keep a close eye on the Food and Drug Administration after a government report found that review times for medical devices has "increased substantially in recent years."
The two senators presented the Government Accountability Office report during a Senate hearing on medical device user fee legislation, which expires Sept. 30. The report found that the agency is meeting its review time goals under existing user fee legislation, but that those review times exclude the time it takes companies to comply with the agency's requests for more information.
"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," the senators said in a joint statement. "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."