The US Food and Drug Administration (FDA) has released an updated standard operating procedure (SOP) aimed at defining the process by which agency staff can resolve differences of opinion between staff regarding the safety or efficacy of a medical device.
The SOP, entitled SOP for Resolution of Internal Differences of Opinion in Regulatory Decision-Making, was published by the Center for Devices and Radiological Health (CDRH) on 10 September 2012. The document explains that it is the role of CDRH to reach an "institutional decision" on each regulatory action to be taken, but that unanimous alignment of decisions is not always possible and is not expected, said CDRH.
Regardless of the final decision, "It is important that the official administrative file captures these differences and the resolution thereof," CDRH writes.
A History of Conflict and Black Eyes
The publication of the SOP by CDRH's ombudsman comes after years of criticism and some high-profile scandals involving reviewers who said their views were not adequately captured or were outright ignored in the regulatory review process. A June 2012 report by the Department of Health and Human Services' Inspector General found 36 scientific disagreements occurring between 2008 and 2010, but found such disagreement dropped off sharply after new conflict resolution procedures were put into place in 2009.
"CDRH … faces broader challenges in identifying and resolving scientific disagreements because of uncertainty about regulatory definitions and processes and staff perceptions about expressing differences of opinion," wrote the Inspector General's office. The inspector went on to recommend that FDA define its conflict resolution procedures more carefully, train its reviewers more thoroughly and make accountability for the contents of submission files more clear.
The topic of conflict resolution would rear its head later in 2012, when FDA was sued by a group of whistleblowers alleging their concerns about the safety of some medical devices had been covered up by senior CDRH officials, who then signed off on a surreptitious monitoring program that spied on their activities.
The scandal has been a black eye for the agency, whose actions have attracted the attention of both the media and legislators clamoring for answers about the program.
Addressing OIG's Concerns
The SOP is largely structured to update an earlier 2009 version of the same document to take into account the recommendations of the Inspector General's report and experience gained by the industry under the recent whistle-blowing scandal.
Reviewers are now expected to exhaust normal channels of communication before initiating a dispute resolution process, and are expected to maintain, "An atmosphere of openness, trust, professionalism and mutual respect." The agency said nothing in its policies should be construed as hampering whistleblowers, however.
The SOP also establishes a step-wise approach for dispute resolution, starting with the next highest management official in the CDRH chain of command. CDRH officials must fill out a form of initiation, which is then given to the CDRH ombudsman for evaluation within 10 days. If it is deemed to be worthy of consideration, it is then passed on to the next highest management official in the chain of command, who will re-evaluate the application. This process may continue if the original decision is overturned, and another official believes it was reversed in error.