ship. The committee is not aware of any collaborations with DoD on such studies,11 but DoD provides health care coverage to over 9 million persons and has excellent epidemiologic research capacity, easily accessible research subjects, and a national interest in the safest and most effective use of drugs for troop readiness and cost containment for the largest health care system in the country. That is why the committee included DoD in the partnership. NIH has supported many important such trials, and the committee expects it will continue to do so. Each agency in the collaboration will need staff dedicated to this work in addition to information-technology upgrades and administrative support.

Discussions about needed confirmatory studies should include regulatory findings and related advisory committee input, should address major study-design issues, and should lead to studies that supplement and complement those being done by industry sponsors as part of their postmarket study commitments. The committee urges industry to use the expertise of the proposed public-private partnership for comment on the design of studies and for oversight of study conduct and analysis of results. Proposals for all confirmatory drug safety studies, whether funded or conducted by public or private entities, should be subject to a peer-review process modeled after NIH study sections to ensure scientific excellence.

An important outcome of the partnership should be that federal agencies provide FDA access to all administrative databases12 (under conditions consistent with the protection of patient privacy) managed by the federal government for purposes related to postmarketing surveillance, safety monitoring and analysis, and risk-benefit assessment of approved drugs.

Funding for the studies planned by the partnership would come from different sources, including congressional appropriations, depending on the questions to be addressed. Some studies planned under this partnership would have been conducted absent the partnership; therefore, the resources needed are not all additional costs to the system. It is hoped that the partnership would help prioritize questions and advise on important study design issues. The partnership might also facilitate collaborations that otherwise would not occur. The committee believes that industry bears the responsibility for paying for clinical trials and other observational studies which support a product’s approval and its safe and effective use (e.g., specific


DoD and other agencies have collaborated in planning and analyzing complementary studies of the safety of the smallpox and anthrax vaccines.


This could be accomplished by training CDER staff to use the databases directly or to work with staff in the other agencies. In either arrangement, new staff will be needed to implement this recommendation. Access to the databases could be obtained through an interagency task force (either existing or to be created) including representatives of FDA, representatives of federal agencies that manage medical databases, and other members to coordinate and ensure effective use by FDA of such medical databases for postmarketing drug safety.

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