Industry to FDA: Why Publicize Unsubstantiated Device Safety Signals?

Regulatory NewsRegulatory News | 01 April 2016 |  By 

Industry groups are raising some serious questions with the US Food and Drug Administration’s (FDA) proposal to release emerging safety signals to the public even before those signals have been substantiated.

In January, FDA released draft guidance outlining how it plans to track and release early signals on medical device safety. The release of such information is expected to be for concerns that have yet to be fully analyzed, validated or confirmed by the agency and will come in addition to the recall notices, safety communications and press releases that the agency already puts out.

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.

Sen. Patty Murray (D-WA) praised the release of the draft guidance though others questioned how risk data that hasn’t been fully validated or analyzed can be reliable.

Industry Comments

In comments released Friday on the draft guidance, industry group AdvaMed took particular issue with FDA’s failure to “articulate a reasonable basis to communicate emerging signals to the public. In fact, FDA acknowledges that the release of an emerging signal to the public may deter use of a safe and effective medical device. A scientifically-driven regulatory agency should define clearly the strength of evidence and uncertainty that has resulted in the public communication of information about previously cleared or approved devices.”

In addition, AdvaMed questions FDA’s statutory authority to communicate such emerging signals and notes that the release of incorrect, incomplete, or misleading information on a device will negatively impact its use and patient well-being. FDA’s current ability to communicate information on medical device reporting, recalls and associated communications via safety communications, alerts and press releases is sufficient, the group said.

“We are profoundly concerned that emerging signal communications issued prior to the Agency having adequate, fully analyzed, validated and confirmed evidence, and without appropriate instructive recommendations, will create unnecessary confusion for healthcare providers and patients and could have unintended consequences including an adverse impact on public health and long-lasting reputational damage to valuable devices,” AdvaMed said.

Moreover, the Quality System Regulations require manufacturers to continually evaluate risks associated with their devices through postmarket monitoring activities and initiate corrective actions when necessary, the group notes.

The Medical Device Manufacturers Association (MDMA) also commented on the draft guidance, noting that the US is recognized as the world leader in medical device safety, and it is “unclear how this additional process would improve the system. In fact, there may be unintended consequences related to unvalidated information being relied upon by patients, providers and the public to make certain clinical decisions that may not be in a patient’s best interest.”

Novo Nordisk also questioned whether FDA intends to notify the manufacturer prior to the public notification of an emerging signal, while Abbott said that FDA needs to ensure that decisions to issue such communications are consistent and scientifically appropriate.

GE Healthcare also raised concerns that the process denoted in the draft guidance does not include adequate verification and validation of such emerging signals by manufacturers before public release.

Merck, meanwhile, urged FDA to revise the draft guidance to state that the agency will seek feedback and allow comments from the manufacturer throughout the process of determining whether an emerging signal exists and after a public communication has been issued.

Docket of 21 Comments


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