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.
Skip to Highlights
Highlights
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.
Recommendations
Matter for Congressional Consideration
| Matter | Status | Comments |
|---|---|---|
| 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. | 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. |
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Food and Drug Administration | 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. |
The agency implemented new reviewer training courses in 1991, with extensive training on the regulatory process. This will be repeated in 1992.
|
| Food and Drug Administration | 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. |
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.
|
| Food and Drug Administration | 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. |
The agency believes that its current practices are appropriate and, given its limited resources, the best possible method.
|
| Food and Drug Administration | 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. |
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.
|
| Food and Drug Administration | 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. |
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.
|
| Food and Drug Administration | 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. |
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.
|
| Department of Health and Human Services | 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. |
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.
|
| Department of Health and Human Services | 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. |
An evaluation of the approval process was completed and no material weaknesses were found.
|
Full Report
Public Inquiries
Topics
Animal husbandryData collectionDrug approvalsEmployee trainingFood and drug lawFood safetyInspectionInternal controlsManagement information systemsPharmaceutical industryPharmacological researchReporting requirements