needed to ensure that those resources are used efficiently and effectively in the service of drug safety.

4.3: The committee recommends that the Secretary of HHS, working with the Secretaries of Veterans Affairs and Defense, develop a public-private partnership with drug sponsors, public and private insurers, for-profit and not-for-profit health care provider organizations, consumer groups, and large pharmaceutical companies to prioritize, plan, and organize funding for confirmatory drug safety and efficacy studies of public health importance. Congress should capitalize the public share of this partnership.


4.4: The committee recommends that CDER assure the performance of timely and scientifically-valid evaluations (whether done internally or by industry sponsors) of Risk Minimization Action Plans (RiskMAPs).


The assessment of risks and benefits is an activity that does not end at approval, and risk and benefit cannot be considered in isolation of one another.

4.5: The committee recommends that CDER develop and continually improve a systematic approach to risk-benefit analysis for use throughout the FDA in the preapproval and postapproval settings.


The committee has made several recommendations to expand the data on drug risks and benefits to improve those decisions. However, in order to plan and use those data, appropriate expertise must be brought to bear. This expertise comes from the CDER staff as well as their advisory committees and other non-governmental experts. The committee believes there is a need to expand this expertise to take on the new responsibilities laid out in recommendations made in this report. CDER will need more expert staff, deeper expertise in the staff it already has, and different kinds of expertise.

With this expanded expertise and resources CDER can be a more effective steward of postmarketing safety and a more credible scientific partner with industry and academia by actively participating in defining important research questions and designing appropriate studies.

4.6: The committee recommends that CDER build internal epidemiologic and informatics capacity in order to improve the postmarket assessment of drugs.



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