Comments of members of the Patient, Consumer, and Public Health Coalition
on the Draft Guidance
Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”)
[Docket No. FDA-2015-D-4803]
As members of the Patient, Consumer, and Public Health Coalition, we support the draft guidance, Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). The draft guidance addresses a serious problem: the delay between early signals that a device is less safe or less effective than expected, and the development of confirming evidence that the FDA would like to have before making recommendations. But in the months or even years during that delay, patients can be and too often have been seriously harmed.
The FDA draft guidance is a step in the right direction, and we look forward to working with the CDRH to ensure that it is implemented in ways that provide easy-to-understand and widely accessible information to patients and their health care providers. Below are our specific comments on the draft guidance.
We support FDA’s precise description of the term “emerging signal,” which is new information about medical devices used in clinical practice that meets four criteria including information that may “alter the known benefit-risk profile of the device.”1
We agree with the FDA that the public needs to be notified about emerging signals “even when the information has not been fully analyzed, validated or confirmed” by the FDA. If this draft guidance had already been policy, then hundreds of thousands2 of patients might have been spared from suffering adverse events from medical devices such as surgical mesh, metal-on-metal hips, power morcellators, contaminated endoscopes, and Essure, to name a few. The FDA has handled the early signals for these five types of devices in different ways, some more successfully than others. In each of these cases, accurate information about risks was not generally known for months or years after persuasive evidence began to emerge. Without any warnings from the FDA that there could be greater risks than those that were officially proved, patients and their doctors could not make informed treatment decisions.
We agree with the FDA that new information about the safety and effectiveness of medical devices “often becomes available once the device is more widely distributed and used under real-world conditions.” We encourage CDRH to consider how often this happens because of the lack of meaningful safety or effectiveness data provided through the 510(k) review process, and how improvements of that review process could reduce problems stemming from lack of definitive information about safety or effectiveness. Shifting the evidence requirement for safety and effectiveness of medical devices from premarket to postmarket allows time for more people to use these devices, which may cause harm. This means that emerging signals including from subpopulations (such as sex-specific, age, ethnic, and racial information) gathered from real-world conditions will become even more important.
The draft guidance cautions about unintended consequence of communicating emerging signals and states that “a beneficial device’s use may be avoided or inappropriately stopped.” Given the slow response of the medical community to new data regarding standard treatments, we believe this risk is relatively minor. For example, patients’ serious problems related to surgical mesh started receiving widespread media coverage in 20083 but after the FDA’s first safety communication in 2008 the use of surgical mesh actually increased (from 21% of all procedures in 2008 to 30% in 2011). Only after FDA released a second more strongly worded safety warning in 2011 did mesh use decrease to 23% in 2013, which was still above the 2008 percentage.4 With that in mind, the FDA can appropriately address this issue by recommending that an emerging signal be “based on reliable data, [so that] the benefits of providing early information to the public outweigh these risks.”1 We also note that the draft guidance specifically defines emerging signals, and lists nearly a dozen specific considerations for determining if the FDA will issue a public notification about an emerging signal. These notifications will be made in a deliberate manner, which should limit negative consequences.
However, the draft guidance on when to communicate and what to say to the public is too restrictive. It states that the FDA should communicate about emerging signals when all of the following statements apply:
- 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 of clinical outcomes;
- The available information is reliable and supported by sufficient strength of evidence; and
- The information could have important clinical implications for patient management decisions and/or could it significantly alter the known benefit-risk profile of the device.
Recommending that all of the statements must apply could stop FDA from alerting the public about emerging signals in a timely manner, and this would be harmful to patients and unfair to healthcare providers. If the first two apply, we strongly urge that be sufficient to require the FDA to release a public communication. Also, in #3, the phrases “important clinical implications” and “significantly alter the known benefit-risk profile” are not clearly defined. That could lead to endless arguments between industry and the FDA, which would delay or have a chilling effect on FDA communicating to the public about possible hazards from a medical device.
We agree with the FDA that when a decision is made not to communicate emerging signals to the public, it should be reassessed within 30 days of the FDA receiving new information regarding safety signals of the device.
We support FDA’s efforts to provide consistency in communicating medical device emerging signals and we support the format, which provides six data points including the name of the device and a summary of the emerging signal. We suggest that FDA add three more items: the device’s 510(k) or PMA number, its UDI number, and a “recall” line. The recall line would show if the device is currently being recalled or has been recalled in the past. In our examinations of recalled devices, it has not been unusual to find a device that has been recalled more than once. Knowing that a device has been modified to address safety or effectiveness issues could help the FDA and the public to focus on possible emerging signals.
For the above reasons, the following members of the Patient, Consumer, and Public Health Coalition support the draft guidance on emerging signals.
Breast Cancer Action
Connecticut Center for Patient Safety
Jacob’s Institute of Women’s Health
Mothers Against Medical Error
National Center for Health Research
National Consumers League
National Women’s Health Network
Our Bodies Ourselves
Quinolone Vigilance Foundation
The TMJ Association
WomenHeart: The National Coalition for Women with Heart Disease
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at email@example.com
- Food and Drug Administration (December 31, 2015). Draft Guidance, Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”) ▲
- Food and Drug Administration (updated 7/16/2015). Webpage: Medical Device Reporting (MDR) notes that “Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions.” ▲
- New York Times (October 22, 2008). NATIONAL BRIEFING | SCIENCE AND HEALTH; Surgical Mesh Tied To Complications. Reported by Bloomberg News. href=”http://query.nytimes.com/gst/fullpage.html?res=9E07E4D61539F931A15753C1A96E9C8B63″>http://query.nytimes.com/gst/fullpage.html?res=9E07E4D61539F931A15753C1A96E9C8B63 ▲
- Sedrakyan, A et al. (February 2016). Regulatory Warnings and Use of Surgical Mesh in Pelvic Organ Prolapse. href=”http://archinte.jamanetwork.com/article.aspx?articleid=2475021&resultClick=1″>http://archinte.jamanetwork.com/article.aspx?articleid=2475021&resultClick=1 ▲