the lifecycle will require increased transparency toward FDA in the process of elucidating and communicating emerging information about a drug, and acceptance of changes intended to strengthen drug safety. Importantly, FDA’s credibility is intertwined with that of the industry, and a more credible drug safety system is in everyone’s best interest. For the health care delivery system, a lifecycle approach to risk and benefit implies the need to heed and follow FDA communication about drug safety matters and to exercise appropriate caution in drug-related decision making (from formularies to prescribing) in recognition of the limited information available at the time of drug approval. Also, the health care delivery system would benefit from consistently basing prescribing decisions on the science, and exercising caution in regard to the industry’s influence on the practice of medicine. Health care organizations and professional societies could contribute to prescribers’ understanding of the evolving science behind the assessment of drug risk and benefit. The academic research enterprise could enhance its contributions of data to the assessment of risk and benefit at all points in a drug’s lifecycle, continue its crucial advisory relationship with FDA, and uphold the value of complete transparency in recognition of real and perceived conflicts associated with financial involvement with the industry. Other government agencies could contribute to the lifecycle approach to drug risk and benefit by collaborating with FDA and the private sector to ensure that data streams from publicly funded health care settings contribute to an improved drug safety system. The public and patients could do their part by communicating with their health care providers about the pharmaceutical products they are using, learning about and discussing with their providers drug risks and benefits in the context of their health needs and characteristics, informing their providers about side effects they experience, and calling for more useful and timelier information about drug benefits and risks associated with new drugs. The public and other stakeholders could also urge Congress to ensure and sustain adequate funding for FDA.


Organizational Culture

Instability in the Office of the Commissioner has been a serious problem for FDA and CDER in particular. A large, complex, science-based regulatory agency cannot perform optimally in the absence of stable, capable leadership, and clear, consistent direction.

3.1: The committee recommends that the FD&C Act be amended to require that the FDA Commissioner currently appointed by the President with the advice and consent of the Senate also be ap-

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