What Happens When the FDA says, “I don’t know”

The FDA Doesn't Know

The FDA is now trying to track what it’s calling “emerging safety signals.” Recently, a study found a possible link between reduced leaflet mobility in TAVRs and the incidence of stroke in the fall. When people turned to the FDA looking for insight, the agency responded with, “Limited available data do not allow us to fully characterize the causes, incidence, and short- and long-term risks of reduced valve leaflet motion, or to recommend appropriate treatment.” This basically equates to the FDA saying, “I don’t know.”

The FDA has recently released a guidance, which will formalize its practice on notifying the public of situations when the agency is monitoring risks that have not yet been fully validated, and therefore, do not have FDA recommendations. Historically, the FDA has communicated important medical device post-market information after having analyzed available data and, in most cases, after having reached decision about relevant recommendations and about whether or not further regulatory action is warranted. According to the guidance, timely communication about emerging signals is intended to provide health care providers, patients, and consumers access to the most current information concerning the benefits and risks of marketed medical devices so they can make informed treatment choices based on all available information. Such communication may also reduce or limit the number of patients exposed to the potential risk while the issue is being further evaluated.

Considerations for Determining FDA Public Notification will include:

  • Seriousness of the adverse event(s) 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
  • Whether there is a disproportionate impact on vulnerable patient populations
  • Potential for preventing, identifying, monitoring or mitigating the risk
  • Availability of alternative therapies
  • Implications for similar or related devices
  • Anticipated time for completion of initial FDA assessment and development of recommendations
  • Accuracy and availability of information already in the public domain.

The issuance of a formal FDA guidance on this matter suggests that the FDA plans on increasing communication of emerging signals as it develops additional tools, like UDI and post-market monitoring. As this guidance becomes finalizes, it appears as if they will be saying, “I don’t know,” less often.

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