FDA Should Reduce Expensive Antibiotic Testing and Charge Fees Which More Closely Reflect Cost of Certification

The Food and Drug Administration (FDA) certifies batches of antibiotics, insulin, and color additives. Certification involves the testing of batch samples for their compliance with established standards and the issuing of certificates for batches that pass the tests. GAO performed a review of these practices because a comprehensive survey of the FDA monitoring of prescription drugs showed that the current level of antibiotic certification was costly and may not be necessary.

Although the current level of testing of insulin and color additives appears to be reasonable, GAO believes that FDA no longer needs to certify all batches of antibiotics. The level of antibiotic certification should be reduced because: (1) the annual rate of batches rejected from certification has historically been less than 1 percent; (2) the sample units submitted from a batch, and the testing units selected from a sample, may not necessarily represent the quality of the entire batch; (3) the batch certification program is expensive; and (4) FDA has available other less costly means of ensuring the quality of antibiotics. Over the last decade, FDA has made numerous studies and proposals on changing the certification process, but has made few modifications to the process. One proposed change calls for a gradual exemption of most classes of antibiotics from batch certification, considering an increase in surveillance efforts and inspections of manufacturers' processes, and a requirement for some newly approved antibiotics to be temporarily certified. Funds derived from certification support activities not specifically related to the certification process. The agency, therefore, uses certification fees to fund some salaries and expenses which would continue even if the certification program was reduced or eliminated. If the program was reduced, other funds would be needed to support activities which are not related to certification now supported with certification fees. Insulin and color additive fees also support activities unrelated to their certification.

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.

Director: Franklin A. Curtis Team: General Accounting Office: Human Resources Division Phone: (202) 275-5451