Pressure to monitor more postmarket data undermines research advisory and review activities.

The Food and Drug Administration is having difficulty fulfilling the high expectations of all its constituencies. It faces an ever-expanding portfolio of oversight and regulatory responsibilities, coupled with depleted resources and a decimated work force. The need to establish a host of new rules and policies to implement the FDA Amendments Act (FDAAA) makes matters worse-at least for the short run. And pressure to beef up postapproval surveillance has increased the strain on new drug review operations.

Review discretion

The situation has become so serious that John Jenkins, director of the Office ...

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