On June 5, 2012, the Office of the Inspector General (“OIG”) published a report entitled, “Executive Summary: Scientific Disagreements Regarding Medical Device Regulatory Decisions.” The Summary, found here, details a study undertaken by the OIG, an office in the Department of Health and Human Services (“HHS”), wherein the Office examined the instances of disagreement that occurred during the medical device review process for the years 2008-2010. In conducting the study the OIG surveyed managers and reviewers from the U.S. Food and Drug Administration’s (“FDA’s”) Center for Devices and Radiological Health (“CDRH”) and asked these individuals to identify the scientific disagreements that occurred during that period. Of the thirty-six (36) reported disagreements, OIG conducted an assessment of the measures taken to resolve the disagreements and determined the ultimate results thereof.
In 2009, CDRH adopted new policies to aid reviewers in resolving internal scientific disagreements. Prior to the adoption of these policies, CDRH reviewers were directed to discuss such disagreements with supervisors and attempt to resolve issues through informal means. With the implementation of a new Staff Manual Guide, effective January 13, 2009, the FDA directed each individual center to develop its own procedures for resolving scientific disagreements. In October 2009, CDRH published its Standard Operating Procedure (“SOP”) detailing how it would handle these issues. In contrast to the former, the new policy outlines a formal process for resolving scientific issues. According to the procedures, reviewers are encouraged to first discuss any differences in an attempt to reach resolve disagreements. If no resolution can be reached, a reviewer may then take advantage of the new procedures by drafting a memorandum detailing his or her position with respect to the matter. The memorandum will then be evaluated by another party who is not otherwise involved in the review. More information about the new procedures may be accessed here.
As a result of the study, the OIG found that only three of the 36 disagreements occurred after the adoption of the new procedures and that these procedures were used in each of these cases to resolve the disagreements. However, despite the actual implementation of such procedures, the OIG found that more could be done by the CDRH to handle scientific disagreements. In particular, the OIG recommends the FDA:
(1) define more clearly its requirements for documenting and resolving scientific disagreements, (2) train all reviewers and managers on the new policies and procedures for resolving scientific disagreements, and (3) more clearly assign accountability for the contents of the administrative files of all submissions. FDA concurred with our three recommendations.
In its report, OIG noted the FDA’s concurrence with all of the above recommendations. In sum, despite making progress in resolving scientific disagreements in the medical device review process, it appears that the FDA still has its work cut out for it.