logic drugs (FDA, 2006a). Advisory committees roughly match the medical specialties of the review divisions in OND. In addition, the Drug Safety and Risk Management Advisory Committee provides guidance on issues related to safety and research methods (CDER, 2005a).

Typically, advisory committees are convened when applications involve new or complex technologies or to address controversies (FDA, 2006b). Sometimes, they are used to address general concerns not related to the approval of a specific product, such as the acceptability of a particular study design or the use of a particular endpoint as a surrogate (FDA, 2006b). Committees convened to assess an NDA may be asked to comment on whether the data support product approval; on some unique aspect of safety, effectiveness, or clinical development of the product; on whether additional studies are needed; or on whether changes should be made in a drug’s label or other action should be taken in response to new risk information after a drug is approved.

After presentations by the sponsor and agency representatives and a public comment period, the committee members usually vote on the questions posed to them by FDA staff. The votes are not binding (FDA, 2006b), but FDA decisions usually are consistent with the majority vote. The meetings can lead FDA to request additional information from the sponsors.

Safety Tracking

As described in Chapter 1, FDA has been under pressure to speed drug reviews and get promising therapies to patients sooner (Lurie et al., 1999) for at least two decades. PDUFA established goals for speed that, as noted, have resulted in substantial decreases in review time. However, no comparable safety goals drive the review process. Case studies of specific drugs point out both the strengths and the weaknesses of FDA’s investigation of safety signals in specific instances, but there seems to be no overall metric in place comparable with measures of speed to track how safety is being monitored and assessed.

Individual drug evaluation offices in OND seem to differ in how and the extent to which they track safety issues regarding drugs that they are reviewing. The committee has been told that for the last 2–3 years OND’s senior leadership has listed and tracked safety issues by office at its weekly meetings (IOM Staff Notes, 2005–2006). Difficult or controversial safety issues are sometimes discussed at “regulatory briefings,” which are attended by staff from various parts of CDER and allow wider input on important questions faced by individual divisions, promote consistency in approach and decision-making, and raise awareness of emerging issues throughout CDER.

In response to congressional and public concerns, CDER has expanded



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