Tuesday, March 22, 2011

Vol. 1, No. 6: Should FDA Restructure Its Drug Review Process?

Should FDA Restructure Its Drug Review Process?
Scott Gottlieb, Fellow, American Enterprise Institute

Gottlieb explores the issue of disagreement among FDA’s Center for Drug Evaluation and Research scientific staff, which he calls disruptive to the drug review process. According to Gottlieb’s analysis, FDA groups scientists in ways that prevent cooperative interaction. He specifically recommends a reorganization of review staff, grouping personnel by areas of therapeutic focus rather than scientific discipline.

The author specifically recommends that FDA should:
  • Group more of its review staff around areas of therapeutic focus rather than scientific discipline to prevent fragmentation of its scientific staff.
  • Organize review staff based on a matrix that is focused around projects rather than review functions in order to foster more scientific collaboration.
  • Create an Office of the Chief Medical Officer as part of the drug review structure, to mediate conflicting opinions between review staff.
  • Assemble review teams that work on multiple projects and build cohesion across several reviews, rather than rely on temporary work groups that are brought together for each individual application.

This article is available for download at http://fdli.org/pubs/policyforum/ now. All issues of FDLI's Food and Drug Policy Forum are free to FDLI members and can be purchased by non-members.

If you have any difficulty posting your comment, please contact Sarah Sansolo at sks@fdli.org.

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