Congressman Brett Guthrie (R-KY), who serves at the Republican Leader of the Energy and Commerce Health Subcommittee, and Congressman Seth Moulton (D-MA) introduced the Emerging Signals Modernization Act, a bill to improve the Food and Drug Administration’s (FDA) process of reporting of an adverse health event, or safety signal, due to a medical device.
“The FDA’s current process for reporting safety signals is inconsistent and often leads to confusion among health care providers, which can limit a patient’s access to care,” says Congressman Guthrie. “That’s why I introduced a bill to require the FDA to follow a clear and evidence-based standard when communicating safety issues. My bill also requires the FDA to reassess publicly issued safety warnings if there is evidence to suggest the safety issue was not directly linked to the device. This commonsense approach strikes the careful balance of maintaining patient safety and creating regulatory certainty needed to ensure patients do not lose access to beneficial care. I look forward to working with my colleagues on strengthening FDA’s safety signal reporting process.”
In 2016, the Food and Drug Administration issued guidance outlining the agency’s process for communicating “emerging signals,” which is information that may relate to the safety of a medical device. The FDA currently relies on a range of sources when considering whether to communicate an emerging signal to the public, including health care providers and patients.
These communications have significantly impacted patient care. As a result, it is important that the information FDA relies upon is complete and accurate, presented in the right context, and continually assessed. Although the guidance describes some of FDA’s process to issue such communications, there is currently a lack of clarity around the standard by which FDA assesses the data and updates or removes emerging signal communications when warranted.
This legislation would address these important issues in a manner by specifically:
- Requiring the FDA to follow a clear standard based on valid scientific evidence when assessing data that might be used to report a safety signal
- Requiring the FDA to include all relevant data the agency used when reporting a safety signal, including making contradictory data available to the public that might indicate the signal is not directly associated with the device
- Requiring the FDA to notify a device manufacturer once a safety signal is reported and give the manufacturer a chance to respond with their own clinical data about the safety of a device
- Requiring the FDA to periodically review the evidence used to issue a safety signal and assess whether the signal should be rescinded
“Massachusetts is home to a powerhouse medical technology sector that rivals Silicon Valley. For this key industry to continue to grow and thrive, we need better communication between providers, the FDA, and companies to ensure safety reporting is accurate and supports patients,” Congressman Moulton added. “Our legislation would require more consistency in how the FDA both reports medical device safety issues to the public and how it works with the companies to conduct proper reviews. This will prioritize safety and ensure patients can still access quality care.”