In response to Recommendation 4.13 (systematic review and publicizing of all postmarket study results), Dr. Franson agreed that regular CDER review and dissemination of postapproval benefit–risk assessments would enable a more thoughtful approach to communicating benefit–risk information. Not only can a one-time adverse event frighten as much as warn the public, but the burden of proof for safety is usually only a single adverse event, in contrast to the randomized controlled study that is required to establish benefit. Drs. Galson and Unger reported that the FDA plans to publish a newsletter on the agency’s website that will include summaries of the methods and results of postmarket drug reviews; given the proprietary nature of most predecisional information, however, this will be done on a case-by-case basis.

In response to Recommendation 5.4 (evaluation of all data on NMEs within 5 years following approval), the FDA initiated a pilot program to examine whether a periodic review of all data at 18 months postapproval can adequately identify potential safety issues and whether more frequent reviews are needed. Dr. Temple reported that this will be a resource-intensive effort, as it will involve reviewing all data sources (e.g., the Adverse Event Reporting System, further trials, literature reports) and will require using informed human judgment in addition to the data. The pilot program involves four NMEs, whose names the FDA has not yet made public. The reviews will be conducted consecutively using currently available staff and budgeted resources (i.e., review divisions and OSE). Dr. Franson stressed that it is important to look at the information accrued throughout a product’s life cycle, not just through 18 months or 5 years. The above reviews raise questions about how standards will be set and what actions will be taken based on these reviews.



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