Summary

GAO discussed the Food and Drug Administration's (FDA) efforts to address animal drug residues in milk and on the agency's extra-label policy allowing veterinarians to treat dairy cows with higher-than-approved drug dosages. GAO noted that: (1) FDA efforts are ineffective and lack a comprehensive strategy to monitor animal drug residues in milk; (2) FDA has made limited progress in implementing program revisions; (3) states are only testing for 4 of 84 known drug residues; (4) FDA has not approved additional screening tests to test for additional drugs; (5) development of a national database is behind schedule; (6) a new FDA program tests for 12 additional animal drug residues, at an estimated annual cost of $500,000; (7) limited FDA enforcement of the extra-label policy undermines the federal drug approval process and discourages animal drug companies from seeking FDA extra-label approval; (8) FDA lacks effective enforcement and monitoring of veterinarians' extra-label policy use, and cannot detect residues of extra-label drugs used on cows; and (9) FDA cannot control animal drug usage or ensure that illegal or unsafe drugs do not contaminate the food supply.