What is in this article?:
- Antibiotics court order based on 35 years ago
- Long-term use
- On Jan. 6, 2012, the Department of Health and Human Services, Food and Drug Administration (FDA) “published an order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals.”
On Jan. 6, 2012, the Department of Health and Human Services, Food and Drug Administration (FDA) “published an order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals,” an action we wrote about in our Jan. 20, 27, and Feb. 3, 2012 columns. We do not know about others, but we certainly were not expecting any additional action on the use of antibiotics in food-producing animals in the near future.
But we were wrong; only this time the action was the result of a lawsuit and not an action by the FDA. Not only that, the action resulted not from a trial but rather a summary judgment by US Magistrate Judge, Theodore Katz of the United States District Court, Southern District of New York. As Judge Katz writes, in the case of Natural Resources Defense Council, Inc., et al. (NRDC) v United States Food and Drug Administration, et al. “the parties do not dispute the essential facts” (all quotes in this article are taken from the judge’s Memorandum Opinion and Order filed March 22, 2012 and available at http://nysd.uscourts.gov/cases/show.php?db=special&id=162).
Both the NRDC and the FDA filed for a summary judgment and the court’s decision turned primarily on matters of grammar and prior practice. Those interested in those issues are urged to consult the judge’s order, pages 19-54. In this column, we focus our attention on the subject matter of the lawsuit and the action of the FDA required by the Court’s decision.
As Judge Katz writes, “For over thirty years, the FDA has taken the position that the widespread use of certain antibiotics in livestock for purposes other than disease treatment poses a threat to health. In 1977, the FDA issued notices announcing its intent to withdraw approval of the use of certain antibiotics in livestock for the purposes of growth promotion and feed efficiency, which the agency had found had not been proven to be safe. The FDA issued the notices pursuant to [the appropriate statutes]…. Although the notices were properly promulgated and over twenty drug sponsors requested hearings on the matter, the FDA never held hearings or took any further action on the proposed withdrawals.
“In the intervening years, the scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown, and there is no evidence that the FDA has changed its position that such uses are not shown to be safe. In May 2011, after the FDA failed to respond to two Citizen Petitions urging the agency to follow through with the 1977 notices, Plaintiffs filed this action seeking a court order compelling the FDA to complete the withdrawal proceedings for antibiotics included in the 1977 notices.”
After reviewing the history of the “use of antibiotics in food-producing animals, “Katz turns to the antibiotics that are the subject of the NRDC lawsuit: penicillin and two forms of tetracycline. In the 1950’s the FDA properly authorized the use of these antibiotics in animals. “Since that time, penicillin has been used to promote growth in chickens turkeys and swine and tetracyclines have been used to promote growth in chickens, turkey, swine, cattle, and sheep.