Food Safety and Quality

About 80 percent of U.S. livestock and poultry are treated with animal drugs during their lifetime for therapeutic, reproductive, and production reasons. The Food and Drug Administration (FDA) is required to determine whether new animal drugs for use in food-producing animals like cows are safe and effective and whether products like milk will be safe for human consumption. In a pending case, FDA has accused a major drug company of manipulating data supporting a new animal drug. This episode has raised concerns about the adequacy of FDA's ability to ensure the integrity of manufacturer-supplied data. GAO found that FDA cannot ensure the integrity and accuracy of animal drug data because of weaknesses in its two main controls over data submitted by manufacturers to support the safety and efficacy of new animal drugs. FDA's inadequate procedures increase the chance that the agency might approve new drugs for food-producing animals on the basis of invalid, inaccurate, or fraudulent data.

GAO found that: (1) FDA cannot ensure that animal drug manufacturers provide accurate data, because its data reviewers lack adequate training on the new review process and because its Bioresearch Monitoring Program (BMP), which it uses to detect fraudulent data, lacks adequate regulations, does not provide for timely or sufficient inspections, and has an inadequate management information system; (2) although FDA established BMP to inspect at least one study for each new animal drug approval, between fiscal years 1985 and 1990, FDA did not conduct any inspections to verify the accuracy and integrity of data supporting 54 percent of new approved drugs for food-producing animals; (3) although FDA can improve the BMP program, it may be unable to conduct a sufficient number of inspections due to competing priorities for inspection resources; (4) FDA inability to approve new animal drugs for food-producing animals on the basis of valid, accurate data, as required by the Federal Managers' Financial Integrity Act (FMFIA), constitutes a material internal control weakness and hinders FDA ability to fulfill its mission to protect the health and safety of animals and people; and (5) the Department of Health and Human Services also has not complied with FMFIA because it has not fully assessed FDA internal controls for approving new animal drugs, and, as a result, has failed to identify or report any material weaknesses in this program.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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