FDA told to restart drug withdrawals

Court ruling could affect penicillin, tetracycline drugs
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A district court judge ordered federal regulators to restart the process of withdrawing approvals for uses of some antimicrobials in livestock feed.

That process includes evidentiary hearings during which drug producers would be given an opportunity to prove that their products are safe. Antimicrobial uses could be prohibited or upheld, depending on results of such hearings. No appeals of the ruling had been filed by late April.

farmer feeding cattle

U.S. Magistrate Theodore H. Katz of the Southern District of New York wrote in his March 22 ruling that the Food and Drug Administration was obligated to continue proceedings started in 1977, when the agency had determined that some penicillin, chlortetracycline, and oxytetracycline uses in feed—particularly prolonged uses at levels below those needed to cure disease—were selecting for bacteria resistant to the drugs and risking harm to public health.

The FDA hadn't acted on the proposals by May 2011, when five advocacy organizations filed a federal lawsuit that accused the FDA of illegally withholding action on its findings as well as of unreasonably delaying action on two related petitions filed in 1999 and 2005. FDA officials denied the petitions in November 2011 and, in a Dec. 22 Federal Register notice, canceled the 1977 proposals.

The Natural Resources Defense Council, Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, and Union of Concerned Scientists had filed the lawsuit against the FDA and its parent, the Department of Health and Human Services.

The 1977 proposals would have affected uses of tetracycline at "subtherapeutic" levels in feed, with the exception of six applications with no known safe alternatives, and all uses of penicillin in feed. "Subtherapeutic" levels were defined in the notices as those below therapeutic levels needed to cure disease.

The agency indicated in the December 2011 notice that its definition of "subtherapeutic" uses has changed since the '70s, and the FDA "now generally considers disease control and prevention claims to be judicious uses (in other words, therapeutic uses), especially when the drug is administered at the direction and under the oversight of a licensed veterinarian." The notice also states that the U.S. has no currently approved therapeutic uses of penicillins in animal feed.

Katz said in his ruling that the FDA could update its notices prior to reissuing them.

The 1977 notices indicate that the growth benefits of administering antimicrobials in feed had been discovered more than 25 years earlier, when animals were fed discarded products from the fermentation process used to manufacture chlortetracycline.