involve the creation and application of new algorithms and methods to improve the processes of preclinical and clinical drug development and new processes to enable effective safety and efficacy monitoring and evaluation over the entire lifecycle of a therapeutic. If FDA is to take advantage of the many research opportunities, research must be recognized as critical to its core mission and be adequately funded. Opportunities for research bring opportunities for real and perceived conflicts of interest, and the committee urges that these be watched carefully. The committee urges that the research opportunities be linked explicitly to FDA’s regulatory mission. The committee affirms that a strong program of intramural scientific research provides an essential foundation for sound, science-based regulatory policy and performance.

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.

Advisory Committees

Chapter 2 describes some basic characteristics of FDA drug-product advisory committees. Those experts and their input constitute an important resource for FDA in tackling particularly difficult or challenging questions related to its regulated products. Scientific advances, changing technology, and the increasing complexity of new drug products have necessitated the establishment of a strong advisory committee system. Through its advisory committees, FDA can seek advice experts from outside the agency who serve as “special government employees”. The system enables FDA to tap into critical expertise at major research institutions.

Advisory committees are used as a source of independent advice about questions raised by the agency regarding new drugs in the review process,



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