Recombinant Bovine Growth Hormone:

FDA Approval Should Be Withheld Until the Mastitis Issue Is Resolved

PEMD-92-26: Published: Aug 6, 1992. Publicly Released: Aug 6, 1992.

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Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) investigation into the bovine growth hormone and its effects on cows and the food supply.

GAO found that: (1) recombinant bovine growth hormone (rBGH) is orally inactive and species specific; (2) the structure of rBGH is significantly different from that of humans, making it inactive and unharmful in humans; (3) FDA considers additional rBGH research on human safety risks to be unnecessary; (4) FDA guidelines sufficiently addressed animal safety requirements, but reproductive issues remain unresolved; (5) the critical drug efficacy guidelines for rBGH have been met; (6) FDA studies and other reports show that rBGH increases the mastitis rate in cows by as much as 33 percent; (7) increased mastitis leads to increases in bovine antibiotic treatment, which greatens the potential of antibiotic residues in milk and beef; (8) FDA and drug sponsors have not tested for or addressed human tolerances of increased antibiotic residues in milk or beef; (9) rBGH sponsors often fail to adhere to FDA protocol study guidelines; (10) FDA lack of labelling requirements during the investigational research phase of review allows rBGH treated products to be marketed without adequate public knowledge; and (11) the lack of a systematic tracking procedure to monitor firms and drug dosages compromises efficiency and effectiveness of the FDA review process.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: The agency reviewed antibiotic relationships.

    Recommendation: The Commissioner, FDA, should examine the indirect effects of rBGH specific to rBGH products--before approval--to answer specific questions about its safety for human food consumption. That is, given the incidence of mastitis occurring in cows treated with rBGH, FDA should study the degree to which antibiotics must be used to treat these cows and the incremental effects of rBGH treatment on the nation's milk and beef supply.

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

  2. Status: Closed - Not Implemented

    Comments: FDA has concluded the human food safety review by examining the antibiotic issue. Although at the time valid, the recommendation is no longer relevant.

    Recommendation: The Commissioner, FDA, should discontinue the marketing of food products from rBGH-tested animals until the potential risk concerning increased antibiotic levels has been evaluated.

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

  3. Status: Closed - Implemented

    Comments: FDA has held a public hearing on food labelling. FDA is considering whether labelling should be used for all food products, that is, not simply require labelling of food products coming from animals in experimental trials.

    Recommendation: The Commissioner, FDA, should study the feasibility of labelling food products derived from animals being tested with drugs so as to provide the public with information concerning the nature of such products.

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

  4. Status: Closed - Implemented

    Comments: Agency has examined antibiotic risk. It indicates that it will consider indirect risks in its review process.

    Recommendation: The Commissioner, FDA, should avoid potentially dangerous shortfalls of information in human food safety reviews of animal drugs by ensuring that indirect risks are explicitly considered and examined.

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

 

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