Increasing the scientific sophistication of the CDER staff should not happen in isolation. Since the goal is to support good science-based regulatory decision making, a corollary goal is to support the research infrastructure of the agency. Expanded research opportunities should be linked explicitly to FDA’s regulatory mission.

4.7: The committee recommends that the Commissioner of FDA demonstrate commitment to building the Agency’s scientific research capacity by:

  1. Appointing a Chief Scientist in the office of the Commissioner with responsibility for overseeing, coordinating, and ensuring the quality and regulatory focus of the agency’s intramural research programs.

  2. Designating the FDA’s Science Board as the extramural advisory committee to the Chief Scientist.

  3. Including research capacity in the Agency’s mission statement.

  4. Applying resources to support intramural research approved by the Chief Scientist.

  5. Ensuring that adequate funding to support the intramural research program is requested in the Agency’s annual budget request to Congress.

The fast pace of review does not allow CDER reviewers to solicit consistently needed input from the appropriate FDA advisory committee(s) on issues such as postmarketing safety and the need for additional studies.

4.8: The committee recommends that FDA have its advisory committees review all NMEs either prior to approval or soon after approval to advise in the process of ensuring drug safety and efficacy or managing drug risks.

4.9: The committee recommends that all FDA drug product advisory committees, and any other peer-review effort such as mentioned above for CDER-reviewed product safety, include a pharmacoepidemiologist or an individual with comparable public health expertise in studying the safety of medical products.

FDA’s credibility is its most crucial asset and recent concerns about the independence of advisory committee members (who advise CDER in its regulatory decision making), along with broader concerns about scientific independence in the biomedical research establishment, have cast a shadow on the trustworthiness of the scientific advice received by the agency.

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