Internal disputes at the FDA’s Center for Devices & Radiological Health need better management in order to avoid disruptions to the medical device review process, according to the U.S. Dept. Of Health & Human Services’ Office of the Inspector General.
Although most of the disputes involved disagreements over fulfilling agency requirements, some may have come from lack of clarity and uncertainty about the submission process, according to the OIG.
"In some instances, lack of clarity regarding definitions or internal processes may contribute to scientific disagreements," according to the report. "For example, uncertainty about certain elements of the 510(k) process may trigger scientific disagreements."
In 1 dispute, a CDRH manager argued with a review team that a company which failed to provide a complete response to a request for additional information be asked a 2nd time to cough up the data. The review team recommended that the application be denied, as there is no policy for giving device makers a 2nd chance. The manager maintained that while it was not policy, it was "good practice."
The FDA’s device review system got a lot of unwanted attention in the fall of 2010 when a handful of scientists complained that the agency pressured them to approve medical devices despite their own reservations about the health risks.
In an open letter to President Barack Obama the scientists called for "sweeping measures" to end "the systemic corruption and wrongdoing that permeates all levels of the FDA." The proceeding hubbub led the OIG to dig deeper into the CDRH’s management of scientific disagreements.
The OIG conducted a survey of 36 such disputes at the FDA’s devices arm that occurred between 2008 and 2010, finding that only 3 used the agency’s newly developed process for documenting and formally resolving scientific disagreements.
New dispute-management procedures were developed in October 2009, when CDRH began tracking scientific disagreements that arose during new product reviews.
Reviewers aren’t required to use the formal dispute handling system and are encouraged to resolve their disagreements informally if possible, according to the OIG. Of 9 surveyed disputes that occurred after October 2009, 3 used the formal resolution system and 6 were managed informally, according to the report.
Of the 36 disputes surveyed, ⅔ did not relate directly to approval or clearance. Most of the applications required additional information from the device manufacturer in order to resolve the disagreement.
The OIG further noted that reviewers lacked proper training on how to manage differences. Nearly half of reviewers surveyed and about ¼ of their managers reported that they hadn’t received training in the agency’s new procedures.
Not all problems in the scientific disagreement process arose from misunderstanding of procedure. About 1 in 5 survey respondents reported concern that "that expressing a scientific disagreement to management could adversely affect their careers."
Six CDRH reviewers reported incidents in which they felt "pressured to change elements of their written reviews or to not document a scientific disagreement," according to the report, and 2 survey respondents noted that many other survey recipients would not respond to the inquiry itself out of fear that the process was not truly anonymous.
"CDRH’s regulatory decisions have significant implications for the public’s health. Therefore, its processes must ensure the scientific integrity and transparency of those decisions," according to the OIG. "Having robust processes to identify, openly discuss, resolve, and document disagreements among multiple reviewers contributes to that integrity."
The federal watchdog recommended that the CDRH better define requirements for documenting and resolving scientific disagreements, launch training programs for all reviewers and managers on the conflict management policies and clearly assign responsibility for the contents of submissions regarding internal disputes.