FDA will have access to four population-based databases for safety surveillance through its cooperative agreement program beginning in FY 2006, including the newly added Kaiser Permanente California registry.

The agency signed contracts on Sept. 23 with Vanderbilt University, UnitedHealth Group, Harvard Pilgrim Health Care and Kaiser, FDA said.

The Kaiser database includes several large retrospective cohort studies dating back to 1981 and includes links to records of California vital health statistics and cancer registry files.

One advantage of such a database is that it provides information on people who may have left their health plan and thus may not be captured in other registries.

Data from Kaiser patients were used in a retrospective analysis conducted by FDA Office of Drug Safety Associate Director David Graham showing an increased cardiovascular risk for Vioxx . Preliminary study data were presented at a meeting in France in August, just over a month before Merck withdrew Vioxx (¹ Also see "COX-2 Retrospective Study Prompts Review By FDA, Kaiser On Merck’s Vioxx" - Pink Sheet, 30 August, 2004., p. 6).

FDA contracts with four different registries allows the agency to have access to data on different types of populations.

The Vanderbilt University registry provides information on Medicaid beneficiaries, which is unique in that it includes medically high risk patients, low income individuals and many nursing home residents.

The Harvard Pilgrim database gives the agency access to specific information from HMOs and PPOs.

The UnitedHealth database, run by its health information subsidiary Ingenix, has the advantage of being the largest and therefore is the closest to representing the U.S. population in terms of age, race and ethnicity.

The Ingenix i3 Aperio registry has information on over 11 mil. individuals and is expected to expand to 20 mil. by 2007. This surpasses the minimum requirement from FDA's request for proposals that each database contain 2 mil. covered lives within the U.S. as of July 2004. FDA is still in discussions with UnitedHealth about licensing its entire database.

FDA issued an RFP in May seeking access to population-based data resources through its cooperative agreement program (² Also see "FDA Expects To Act On New Drug Safety Cooperative Agreements By Sept. 30" - Pink Sheet, 8 August, 2005., p. 13).

All four databases exceeded the RFP's requirements of being able to capture all health provider encounters, provide drug exposure data and permit long-term longitudinal patient follow-up for adverse drug events with sufficient detail and methodology to allow FDA to make significant conclusions and interpretations.

In addition to the cooperative agreements, FDA's population-based data resources include access to the UK-based General Practice Research Database and special projects with Kaiser Permanente California and the Veterans Affairs Medical System.

Each of the four cooperative agreements is a one year award with an option for four renewals, totaling $1.3 mil. over five years.

This represents a slight increase in agency total annual spending on cooperative agreements, from $900,000 to $1 mil. However, since the agency has increased the number of cooperative agreements to four, each entity will be eligible for a smaller slice of the pie: $260,000 annually rather than the approximately $300,000 allotted previously.

The structure of the funding has also changed; FDA now pays each contractor under multiple award task-order contracts. Under the previous grant system, the FDA would pay each site a set amount annually, irrespective of the number of studies performed.

FDA believes the new system gives it more flexibility because it can now issue a request for a particular study and decide whether to pursue it with a particular contractor based on their response to the request. FDA will pay each contractor based on their work plan and cost estimate for each drug study generated.

[Editor's Note: Additional discussion of FDA's contract with UnitedHealth appeared in ³ "The Pink Sheet" DAILY Sept. 28, 2005. Sign up for a free trial at www.ThePinkSheetDAILY.com.]

FDA Postmarketing Surveillance System Adds Kaiser Retrospective Database

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