Congress has approved the Food and Drug Administration Safety and Innovation Act. On May 30, The House voted in favor of the legislation, which is less stringent but similar to the legislation approved by the Senate on May 24. Both bills must be reconciled by Oct. 1, when President Obama is expected to sign the legislation.
Although the legislation includes improvements over current law, it “fails to address some longstanding flaws in our medical device oversight system that endanger patient safety. Congress is missing the opportunity to fix a broken system that lets too many unsafe medical devices on the market and limits the FDA’s ability to protect patients when problems arise,” Lisa McGiffert, director of Consumers Union’s Safe Patient Project, stated in a press release.
The Senate bill does not include a provision preventing medical devices with known safety problems from being used as the basis for clearing new devices, but a provision would allow the FDA to more easily up-classify problematic devices so that subsequent, similar devices will receive more scrutiny before they get to patients.
Improvements in the Senate bill will:
Create a timeframe for finalizing proposed regulations on unique device identifiers and for implementing these rules. Once these rules are in place, the FDA will be better able to track problematic devices and make sure patients are warned about safety problems.
Add medical devices to the Sentinel Initiative, a mechanism to enhance post market oversight of drugs.
Codifiy the requirement that approval for high-risk devices is contingent on completing required post market studies.
Create a timeline on 522 post-market studies for devices that had been cleared in the fast track process, aiding the FDA in reacting more quickly when device safety issues have been identified. The bill still allows manufacturers to delay beginning these studies for 15 months after the FDA orders them, during which time doctors can still implant these questionable devices.
Require the FDA to do more outreach to involve more non-conflicted experts and groups — including scientific societies, the Institute of Medicine and the American Academy of Medical Colleges — in its recruitment efforts for medical device advisory committees.