By Allyson B. Mullen –
On New Year’s Eve, FDA gave an end of the year surprise to the device industry: the draft guidance “Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').” FDA indicates that the purpose of the guidance is to provide information regarding Emerging Signals to patients, consumers, and physicians about medical devices. The guidance defines an Emerging Signal as “new information about a medical device used in clinical practice:
- That the Agency is monitoring or analyzing,
- That has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device,
- That has not yet been fully validated or confirmed, and
- For which the Agency does not yet have specific recommendations.”
Emerging Signals can include “a newly recognized type of adverse event associated with a medical device, an increase in the severity or frequency of reporting of a known event, new product-product interactions, device malfunctions or patient injuries potentially related to improper device use or design, or a reduction in benefit to the patient.”
While acknowledging that information regarding Emerging Signals will be unconfirmed, the draft guidance indicates that FDA expects the public to use the Emerging Signal information to make treatment choices based on current information. FDA also intends for the communication to limit the number of patients exposed to a potential risk while it is under investigation (read users will limit use of the device after FDA notifies users) and promote vigilance on the part of the public to report occurrences of the event to FDA.
FDA indicates it will consider the following factors when evaluating and communicating about Emerging Signals:
- “Seriousness of the adverse event(s) (e.g., severity and reversibility) relative to the known benefits of the device;
- Magnitude of the risk (e.g., likelihood of occurrence);
- Magnitude of the benefit;
- Strength of the evidence of a causal relationship between the use of a device and the adverse event;
- Extent of patient exposure (e.g., how broadly is the device used, is the device still actively manufactured and distributed);
- Whether there is a disproportionate impact on vulnerable patient population (e.g., children, pregnant women, elderly, cancer patients, chronically ill, at-home/unmonitored);
- Potential for preventing, identifying, monitoring or mitigating the risk;
- Availability of alternative therapies;
- Implications for similar or related devices (e.g., multiple models from multiple manufacturers);
- Anticipated time for completion of initial FDA assessment and development of recommendations;
- Accuracy and availability of information already in the public domain.”
While we agree with FDA that it is important for the public to understand potential risks associated with medical devices, we think there is significant risk with providing unvalidated information too soon. Indeed, FDA acknowledges this risk in the guidance by indicating it is possible such communication could lead to the public not using a beneficial device. The guidance does not, however, provide any mitigation to this risk. FDA says it considers “human behavior in [its] decision to communicate.” However, FDA says nothing about literature showing that people tend to overweight low risks. See e.g., Daniel Kahneman, Thinking, Fast and Slow (Farrar, Straus and Giroux 2011).
Given the risk that users will limit their use of a beneficial device, the fact that the manufacturer(s) is the likely expert on the signal, and that signals can come from sources of varying reliability, we find it surprising that FDA says nothing about consulting with industry prior to issuing any public communication. Nowhere in the draft guidance does FDA indicate that it will consult with or obtain information from industry regarding the Emerging Signals. It is foreseeable that plaintiff’s attorney’s will try to use this mechanism to prompt a notification by FDA. This kind of notification could be a problem in any product liability litigation. FDA needs to take into account the source and quality of the data it is relying on to make notification decisions.
The draft guidance indicates that FDA will make a decision regarding whether to notify the public of an Emerging Signal within 30 days of receiving initial or new information. FDA may provide updated information to the public when new information is obtained, and FDA should provide updates on its website at least twice per year. We find it interesting that FDA states it will provide these updates on its website, but it does not indicate how it will communicate the initial notice. It is possible then that FDA could actively notify the public (e.g., through letters to doctors), but then only provide updated information passively by posting it on the website. This disparity could lead to those who are initially notified of the Emerging Signal not being aware of the updated information posted on FDA’s website. There is also no clear mechanism for companies to provide information for use by FDA in updating its notification.
The guidance also notably lacks any time frames around FDA’s investigation into an Emerging Signal. It appears there is a risk that FDA could notify the public of an Emerging Signal under the guidance, but then not promptly follow through with its investigation. The guidance indicates that before notifying the public, FDA should identify a potential causal relationship between the adverse event or clinical outcome and a device (or type of device) based on reliable information. As we all know, however, a potential causal relationship does not always turn out to be a causal relationship, and if FDA releases a public notice prematurely, the negative effect on the device’s reputation may be irreversible. Thus, it would seem reasonable to us that if FDA were to use this early notification process it should commit to a reasonably expeditious investigation of the issue. No such commitment appears in the draft guidance.
We agree with the premise of the draft guidance, the public should be made aware of the risks and benefits associated with commercially available devices. However, this guidance appears to us to allow FDA to communicate theoretical, unproven risks without balancing that information with the benefits of the device. It is notable that this mechanism for rapid dissemination of information applies only to risks, not benefits. In fact, if the situation were reversed and the manufacturer wanted to notify the public of a new or greater benefit associated with a device, FDA would certainly want validated data. Before finalizing the draft guidance, we hope FDA balances the need to provide the public with up-to-date risk information with the risk of the public reducing or ceasing use of a beneficial device and takes steps to ensure that FDA has a solid foundation for any notification.