As the US Food and Drug Administration (FDA) looks to catch signals of medical device safety issues earlier to prevent adverse events, the agency has put out draft guidance outlining how it will track and release such information publicly.
The release of the new information -- for concerns that have yet to be fully analyzed, validated or confirmed by the agency -- will come in addition to the recall notices, safety communications and press releases that the agency already puts out.
Although some are praising FDA’s decision to be more forthcoming, others, including lawyers, are questioning how and why the agency would release scientifically unverified information publicly.
What is an Emerging Signal?
Under the draft guidance, FDA is defining an “emerging signal” as new information about a medical device: 1) that the agency is currently monitoring or analyzing, 2) that has the potential to impact patient decisions and/or alter the device’s benefit-risk profile, 3) that has not yet been fully validated or confirmed, and 4) for which the agency does not yet have specific recommendations.
“Timely communication about emerging signals is intended to provide health care providers, patients, and consumers with access to the most current information concerning the potential benefits and risks of marketed medical devices so that they can make informed treatment choices based on all available information,” FDA says. “Such communication may also reduce or limit the number of patients exposed to the potential risk while the issue is being further evaluated. In addition, communicating emerging signals may also promote enhanced vigilance on the part of clinicians, risk managers, patients and consumers, who may respond by increasing their reporting to FDA.”
But FDA says it will be cautious with such information, noting that publicly communicating information on emerging signals should only come when: The information represents a new, potentially causal association, or a new aspect of a known association (e.g., increased rate or severity of event or reduced benefit), between a medical device and one or more adverse events or clinical outcomes; the available information is reliable; the information could have important clinical implications or it could significantly alter the known benefit-risk profile of the device.
After the guidance is finalized, FDA staff will conduct an initial assessment of the need to communicate an emerging signal within 30 days of receiving the information. And if the agency decides to not communicate the signal publicly, FDA staff “should conduct an internal reassessment of the decision within 30 days of receiving new information,” the guidance says.
The style of emerging signal communication will look like this:
“This communication reflects FDA’s current assessment of available information about [issue]. It is intended to highlight this information at an early stage in the FDA’s review, before the FDA has completed a full investigation or determined whether this information warrants regulatory action.
Posting this information does not mean that FDA has concluded there is a causal relationship between the medical device and the emerging signal. Nor does it mean that the FDA is advising patients or health care professionals to discontinue or modify use of these products. The FDA will update this document when additional information or analyses become available.
Device (including known benefits and risks):
Summary of Emerging Signal:
Additional Information for Patients and Health Care Professionals (if any):
Ongoing FDA Actions:
How to Report Problems to the FDA:”
Sen. Patty Murray (D-WA) praised the release of the draft guidance just before the new year, noting, “I’m glad that the FDA is taking steps to ensure doctors and patients have emerging safety information that could be critical to making informed treatment decisions, but there is much more that needs to be done.”
Murray previously sent a letter to FDA calling for a full review of the agency’s work on contaminated duodenoscopes, which were linked to outbreaks of antibiotic-resistant infections. The agency has since called on three duodenoscope makers to submit plans to conduct safety studies to help understand the effectiveness of current cleaning procedures for the devices.
Unlike Murray, James Beck, counsel resident in the Philadelphia office of Reed Smith, takes issue with the contradictory nature of the proposed guidance.
Beck points to the criteria that would establish an emerging signal, noting that the statements are “internally – and we would say fatally – contradictory. How can risk data that ‘has not been fully analyzed, validated or confirmed’ nonetheless be ‘reliable and supported by sufficient strength of evidence’? It can’t, not under any standard articulated under either the FDCA or FDA regulations, which is why the draft relies on no articulable regulatory standard but rather a dozen bullet point ‘factors.’
“In lay terms, the FDA is proposing to take regulatory shots in the dark based on preliminary information that is admittedly scientifically unverified and which the agency can’t even say is significant,” Beck adds, noting that there could be some First Amendment issues as well.
“If the FDA presumes to make public statements on the basis of the slim evidence it describes in this proposed guidance, it should expect that the same rules will apply to other speakers under the First Amendment,” he notes.
Stakeholders have 60 days to comment (two anonymous posts already published) on the draft guidance.
Public Notification of Emerging Postmarket Medical Device Signals