Food Safety and Quality:

FDA Needs Stronger Controls Over the Approval Process for New Animal Drugs

RCED-92-63: Published: Jan 17, 1992. Publicly Released: Feb 10, 1992.

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Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) efforts to ensure the accuracy and integrity of new animal drug data that animal drug manufacturers provide as part of the approval process for new animal drugs.

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.

Matter for Congressional Consideration

  1. Status: Closed - Not Implemented

    Comments: FDA submitted a study to Congress in October 1994 that found user fees were a feasible option. However, the 104th Congress, when modifying the Federal Food, Drug, and Cosmetic Act chose not to act on this.

    Matter: Congress should consider the larger policy issue of whether the existing approval process for new animal drugs should be supported by user fees, regardless of the need to expand the number of bioresearch monitoring inspections. Furthermore, if Congress authorizes user fees for approving new animal drugs, it should consider earmarking those funds for FDA to conduct this program.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: The agency implemented new reviewer training courses in 1991, with extensive training on the regulatory process. This will be repeated in 1992.

    Recommendation: To improve FDA controls over the accuracy and integrity of new animal drug data, the Commissioner, FDA, should direct the Director of the Center for Veterinary Medicine (CVM) to follow through with CVM plans to provide training and guidance to new data reviewers on the scientific review of new animal drug applications.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  2. Status: Closed - Not Implemented

    Comments: In 1996, the President signed the Animal Drug Availability Act, which amends the Federal Food, Drug, and Cosmetic Act to add greater flexibility regarding studies required to demonstrate a drug's effectiveness. The act eliminates the requirement for clinical field studies.

    Recommendation: To improve FDA controls over the accuracy and integrity of new animal drug data, the Commissioner, FDA, should direct the Director, CVM, to propose regulations detailing the responsibilities of sponsor/monitor and clinical investigators.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  3. Status: Closed - Not Implemented

    Comments: The agency believes that its current practices are appropriate and, given its limited resources, the best possible method.

    Recommendation: To improve FDA controls over the accuracy and integrity of new animal drug data, the Commissioner, FDA, should direct the Director, CVM, to establish criteria for the number of pivotal studies that should be inspected as part of the new animal drug approval process.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  4. Status: Closed - Not Implemented

    Comments: In 1996, the President signed the Animal Drug Availability Act, which amends the Federal Food, Drug, and Cosmetic Act to add greater flexibility regarding studies required to demonstrate a drug's effectiveness. The act eliminates the requirement for clinical field studies.

    Recommendation: To improve FDA controls over the accuracy and integrity of new animal drug data, the Commissioner, FDA, should direct the Director, CVM, to require drug sponsors to provide adequate advance notification before shipping drugs for clinical trials in order to allow FDA to conduct inspections while trials are ongoing.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  5. Status: Closed - Not Implemented

    Comments: In 1996, the President signed the Animal Drug Availability Act, which amends the Federal Food, Drug, and Cosmetic Act to add greater flexibility regarding studies required to demonstrate a drug's effectiveness. The act eliminates the requirement for clinical field studies.

    Recommendation: To improve FDA controls over the accuracy and integrity of new animal drug data, the Commissioner, FDA, should direct the Director, CVM, to improve the CVM management information system by developing: (1) a system that can track all inspections and sponsor-submitted studies performed throughout the drug approval process; and (2) system standards, procedures, and documentation, for ensuring uniform, accurate, and complete data in the bioresearch monitoring database.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  6. Status: Closed - Not Implemented

    Comments: In 1996, the President signed the Animal Drug Availability Act, which amends the Federal Food, Drug, and Cosmetic Act to add greater flexibility regarding studies required to demonstrate a drug's effectiveness. The act eliminates the requirement for clinical field studies.

    Recommendation: To improve FDA controls over the accuracy and integrity of new animal drug data, the Commissioner, FDA, should direct the Director, CVM, to use the improved CVM management information system to identify critical inspection needs and direct limited inspection resources to those needs.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  7. Status: Closed - Implemented

    Comments: In October 1994, the agency submitted to Congress a report on the feasibility of user fees. However, the agency has no plans to implement a user fee program.

    Recommendation: If, after taking actions to improve controls over new animal drug data, FDA can document that it needs additional resources to expand its inspection activities for approving new animal drugs, the Secretary of Health and Human Services should consider asking Congress for additional funding or specific authority to charge user fees earmarked to pay for the expenses of approving new animal drugs, including the costs of conducting bioresearch monitoring inspections.

    Agency Affected: Department of Health and Human Services

  8. Status: Closed - Not Implemented

    Comments: An evaluation of the approval process was completed and no material weaknesses were found.

    Recommendation: The Secretary of Health and Human Services should include the FDA lack of sufficient controls to ensure the accuracy and integrity of sponsor-submitted animal drug data as a material weakness in his next internal report to the President, as required by the Federal Managers' Financial Integrity Act.

    Agency Affected: Department of Health and Human Services

 

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