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

HRD-82-11: Published: Oct 28, 1981. Publicly Released: Oct 28, 1981.

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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 for Executive Action

  1. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: The Secretary of Health and Human Services should require the Commissioner of the Food and Drug Administration to: (1) develop a strategy for reducing the level of antibiotic testing; (2) assure through selective certification and alternative means, such as inspections and postmarking surveillance, that manufacturers continue to comply with the established standards for manufacturing antibiotics; and (3) periodically assess the need to continue batch certification of insulin and color additives.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Not Implemented

    Comments: FDA has discontinued all premarket certification of antibiotics. Therefore, this recommendation is no longer needed.

    Recommendation: The Secretary of Health and Human Services should require the Commissioner of the Food and Drug Administration to: (1) establish a more restrictive definition of "certification-related activity" to include only activities which are related directly or indirectly to the certification process; (2) absorb in appropriated funds staff positions determined not to be involved in antibiotic, insulin, and color additive certification; and (3) develop an accurate method for allocating staff time and cost to the certification program.

    Agency Affected: Department of Health and Human Services


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