FDA Expands Use of Real-World Evidence

FDA relaxes regulation of real-world evidence, which allows expedited reviews on drugs and medical devices that have no identifiable patient records.

The US Food and Drug Administration has revised their review framework to enable them to use real-world evidence (RWE) when making an application for the drug and medical device without the need to identify the patient. The step is likely to hasten the review of the regulations and safeguard privacy.

In the past, use of RWE in submissions of products was restricted by the rigorous demands surrounding the information about individual patients. Even though RWE has been informing regulatory policy over the years, it was typically not included in the formal applications, which slackened innovation in hospital equipment. Over 250 premarket approvals of medical device products have contained RWE since 2016, but uptake of it has now stagnated because of privacy issues.

In the revised strategy, FDA reviewers will determine the quality and relevance of the submitted RWE on a case-by-case basis. The agency recognized that significant information could be obtained using large, de-identified datasets without interfering with the privacy of patients.

FDA Commissioner Marty Makary claimed that the reform will eliminate the unneeded hurdles and it will accelerate delivery of life-changing treatments to patients. He identified access to major databases like cancer registries, hospital system records, insurance claims, and electronic health record networks.

To the medical device business, the change will provide wider access to real-life health care data that is representative of diverse groups of people and care environments. These insights could supplement conventional clinical trials and help generate stronger evidence, which may accelerate innovation and improve patient outcomes across the medical device landscape.