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These include: - Rush to approve: Working under tight deadlines and with sometimes skimpy, unrepresentative data, the FDA reviews drugs at a pace that may make sound decisions difficult.

Some FDA reviewers say that their bosses have pushed them to approve medications despite their reservations about safety.

- A powerless FDA: The agency lacks the effective power to force companies to complete studies after drug approval, compel doctors to report adverse reactions, or dictate new warning labels.

The agency's regulatory might also has been undercut by limited resources, dependency on drug company fees to help finance the review process, and what critics claim is a lack of will to enforce tough requirements.

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