Food Safety and Quality:

FDA Strategy Needed to Address Animal Drug Residues in Milk

RCED-92-209: Published: Aug 5, 1992. Publicly Released: Aug 5, 1992.

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Pursuant to a congressional request, GAO reviewed: (1) states' and the Food and Drug Administration's (FDA) control of animal drug residues in milk; and (2) the FDA extra-label drug use policy.

GAO found that: (1) FDA is responsible for approving new animal drugs, monitoring the distribution of drugs, and determining the safety of food products from treated animals; (2) by law, use of an animal drug in a manner inconsistent with its approved labelling is illegal; (3) under the FDA extra-label use policy, only veterinarians are allowed to use drugs in an unapproved manner, and only in emergencies; (4) states do most required monitoring, enforcement, and other regulation, while FDA ensures that states comply with all rules and regulations; (5) although reliable data are unavailable, approved and unapproved use of drugs on dairy cows is thought to be widespread; (6) states routinely test for only 4 of 82 drugs that could leave residues; and (7) states and the dairy industry were to expand their testing for drug residues, but FDA did not meet deadlines for recommending additional tests, and additional screening methods will not be available before 1993. GAO also found that: (1) limited enforcement of the extra-label use policy undermines FDA control of animal drugs; (2) veterinarians must rely on available information and their best judgment and experience in extra-label use cases, but may lack adequate information; (3) FDA cannot ensure that extra-label use conditions are followed by veterinarians because it does not routinely monitor compliance or have the ability to detect all residues; (4) drug manufacturers may have little incentive to obtain approval for new drugs and uses due to veterinarians' indiscriminate use and FDA inability to enforce its policies; and (5) proposed legislation to legalize extra-label use may provide a further disincentive to manufacturers.

Recommendations for Executive Action

  1. Status: Closed - Not Implemented

    Comments: FDA concurred with the need to collect data on veterinarians' extra-label use of animal drugs. FDA, however, believes that this is an ongoing process and that it is doing what it can given resource and technology constraints.

    Recommendation: The Commissioner, FDA, should obtain data on veterinarians' extra-label use and prescriptions of drugs to determine: (1) whether, and to what degree, the conditions of the policy are followed; and (2) whether to withdraw approval of a drug because its labelled directions are not being followed in practice--that is, the drug is used extensively in an extra-label manner. FDA could consider several of the options discussed in this report for collecting the data.

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

  2. Status: Closed - Not Implemented

    Comments: FDA does not believe that it needs to revise its extra-label use policy at this time. FDA has agreed to revise the policy if the need should arise.

    Recommendation: The Commissioner, FDA, should revise the extra-label use policy to further restrict its use, such as to specifically preclude the use of drugs not approved for use in at least one food-producing animal species.

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

  3. Status: Closed - Not Implemented

    Comments: FDA did not concur because it believed it had examined the issue thoroughly.

    Recommendation: Because insufficient data are available to fully address some of the difficult public policy and animal welfare issues related to extra-label use of approved drugs on food-producing animals, the Commissioner, FDA, should request that the new National Academy of Sciences' panel on animal health and veterinary medicine give priority to evaluating the need for extra-label uses and whether veterinarians have sufficient information to make informed decisions on the efficacy and safety of extra-label uses. The Academy could also explore alternatives for FDA to take enforcement actions when drugs are used in an illegal manner on food-producing animals.

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

  4. Status: Closed - Not Implemented

    Comments: Although FDA concurred and has stated that it will prepare a comprehensive strategy to monitor milk for animal drugs, this strategy has been unavailable for the last 5 years. GAO believes, therefore, that the agency has no intention of responding to this recommendation.

    Recommendation: To better ensure the safety of the nation's milk supply, the Commissioner, FDA, should develop a comprehensive strategy to monitor milk for animal drugs that optimizes state and industry testing under the Milk Ordinance, outlines FDA offices' roles and responsibilities, and integrates the various efforts to improve milk monitoring. The strategy should, at a minimum, include: (1) developing an action plan to implement the 1991 revisions to the Milk Ordinance, focusing on those drugs that pose the greatest threat to the safety of the nation's milk supply; (2) resolving which types of test methods and what level of precision are necessary for the states and industry to use under the Milk Ordinance; (3) conducting a cost-benefit analysis of FDA updating older regulatory methods rather than trying to compel drug manufacturers to update their older methods; and (4) reexamining the objectives and mission of the FDA monitoring program to determine its relationship to state and industry testing under the Milk Ordinance and the costs and benefits of this program versus increased funding for other efforts needed to implement the revisions to the Milk Ordinance.

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

  5. Status: Closed - Not Implemented

    Comments: FDA concurred with the need to allow more flexible labelling for prescription drugs. However, in passing the Animal Drug Availability Act, Congress has allowed drug manufacturers the option to use flexible labelling that permits a range of acceptable recommended doses.

    Recommendation: The Commissioner, FDA, should consider options, such as professional labelling, to develop an expedited approval process that would encourage animal drug manufacturers to seek approval of new dosage claims and proper withdrawal periods.

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

 

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