describes some of the limitations related to the FDA’s current regulatory capacities. Recommendation 5 has two parts due to the differing regulatory frameworks surrounding drugs, devices, and biologics as compared to foods and supplements. Its intent is parallel, nonetheless.

In addition to strengthened FDA regulatory capacity, the committee acknowledged that science-based decision making is reliant on the availability of scientific data. Although there are ongoing efforts to collect and analyze biomarker data, the committee concluded that these efforts are uneven and not optimally organized within the U.S. Department of Health and Human Services (HHS). Recognizing the value of a well-coordinated, comprehensive effort to collect and share biomarker information in advancing public health, the committee sought to improve ongoing biomarker data collection efforts. Improved FDA information infrastructure and surveillance systems may also enhance the agency’s ability to interpret biomarkers and their relation to public health. Based on these findings, the committee made the following recommendation:

Recommendation 6:


The U.S. Department of Health and Human Services should facilitate a coordinated, department-wide effort to encourage the collection and sharing of data about biomarkers for all uses, including drugs, biologics, devices, and foods.


The FDA in coordination with other federal agencies should build needed data infrastructure and surveillance systems to handle the information necessary to gain sufficient understanding of the effects of biomarker use.

The second part of this chapter reviews the FDA’s infrastructure capacity, and ongoing biomarker data collection efforts. Opportunities to facilitate data collection and sharing, such as precompetitive collaboration, will also be highlighted.


Several federal agencies have responsibility for public health. In addition to the FDA and the other 10 agencies that comprise HHS, HHS also collaborates with units within the Departments of Defense, Veterans Affairs, Agriculture, and Education in carrying out its public health responsibilities. The FDA’s mission is as follows:

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing

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