its safety-oversight infrastructure over the last 2 years. In 2006, a new position of associate center director for safety policy and communications was created in CDER with responsibility for overseeing safety issues (FDA, 2006c). In early 2005, the Drug Safety Oversight Board was created to increase both oversight and transparency in matters of safety (CDER, 2005c). It is too early to know whether those highly publicized initiatives will strengthen oversight of and communication about safety.

Dispute Resolution

Differences of opinion among reviewers may surface at various points during the review process or in the postmarket period. Sometimes, they reflect different professional perspectives on how to assess and weigh the types of data available and draw a conclusion. The evaluation of drugs is a team process, incorporating experts in a wide array of disciplines who must work together effectively. Furthermore, reviewers rarely have all the information they would like to have to make the required scientific determinations; in this environment of scientific uncertainty, legitimate differences of opinion on the appropriate course of action are inevitable. But a regulatory decision must be reached and must incorporate the most persuasive and compelling scientific assessments, while leaving all participants feeling that they have been heard.

Disparate views may be discussed at global assessment meetings when the whole review team tracks the review in progress or in other informal or official meetings. Where disagreement persists, upper-level supervisors have traditionally had responsibility for evaluating the options and making a decision to resolve the disagreement.

In a few high-profile cases, internal disagreements about CDER’s handling of safety issues on particular drugs or in general have been aired in the mass media or in congressional hearings (Graham, 2004; Hensley et al., 2005; Neergaard, 2005). Surveys of CDER staff reveal some concern about decision-making regarding postmarketing safety (DHHS/OIG, 2003). (See Chapter 3 for more information on this topic.)

In November 2004, CDER created a pilot program in the CDER ombudsman’s office to provide a forum to discuss and resolve differences (MAPP 4151.210). It provides for dispute resolution at the center direc-


This MAPP provides a new pilot procedure for CDER staff to express their differing professional opinions (DPOs) concerning regulatory actions or policy decisions with substantial public health implications in instances when the normal procedures for resolving internal disputes are not sufficient. The DPO procedure provides short timeframes for hearing a differing professional opinion so that it can be resolved expeditiously, review of the DPO by qualified staff not directly involved in the decisions, and evaluation of the pilot after 1 year to determine whether it adds value to the regulatory decision-making process.

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