Metrics Needed to Evaluate ‘Least Burdensome’: GAO
The Government Accountability Office (GAO) says FDA should develop and use performance metrics to evaluate its implementation of the requirement that it consider the least burdensome means of evaluating a medical device. FDA commissioner Scott Gottlieb says he agrees with the findings of the GAO report.
The report describes (1) FDA requests for additional information from medical device sponsors and the sponsors disagreements; (2) the agency’s least burdensome training efforts; and (3) FDA actions to improve its requests for additional information and examines the extent to which it has evaluated its implementation of the least burdensome requirements.
GAO says that from 2001 through 2016, FDA issued letters asking sponsors to provide additional information for a majority of the more than 62,000 medical device submissions that it reviewed. Sponsors appealed FDA decisions internally to agency management 63 times from 2013 to 2016, the report says, and FDA identified 33 such appeals in which the sponsor raised an issue related to least burdensome requirements. FDA agreed or partially agreed with the sponsors in 11 of the cases.
“FDA has not specifically evaluated implementation of the least burdensome requirements,” the report says. “However, in response to broader evaluations, such as an independent assessment of its medical device review process, the agency is in the early stages of developing processes that may improve its requests for additional information…. In 2002, FDA stated that it planned to periodically assess the implementation of the least burdensome principles, and federal internal control standards identify the importance of performance metrics for such assessments. However, the agency has yet to develop performance metrics to do so. Until such measures are developed and used, FDA will not be able to evaluate whether it effectively and consistently applies a least burdensome approach in its medical device reviews.”
In his response, Gottlieb says “an effective and consistent least burdensome approach is essential for evaluating novel devices under FDA review as well as accommodating iterative improvements to existing devices already on the market. FDA has taken steps to apply this approach since Congress first enacted the least burdensome provisions in 1997, which have already resulted in benefits to public health. We’ve recently taken new steps to further advance and expand these goals.”
He cites a number of guidances that have been issued and the training that has reached 90% of the CDRH staff. Gottlieb emphasizes that the stringent review standards will not change. “Patients must continue to trust in the medical products that we review for safety and effectiveness before they go on the market,” he writes.