Breaking News: Judge Orders FDA to Examine Safety of Ag Drugs

Here’s breaking news that I’ve learned about. The significance is going to unfold over the next 24 hours and more, and when it does, I will update. (Update: Overnight, a lot came out about this, so I’ve wrapped it all into a new post here.)

Here are the basics:

A district judge in New York has ruled in favor of a coalition that sued the Food and Drug Administration in order to compel the agency to follow through on its 35-year-old attempt to exert control over antibiotics in animal feed known as “growth promoters” — tiny doses of antibiotics delivered in feed and water that are believed to stimulate the evolution of antibiotic-resistant organisms.

Technically, Magistrate Judge Theodore H. Katz has granted the groups’ motion for summary judgement, and denied the FDA’s request that the suit be dismissed.

The decision, filed this afternoon, does not compel the FDA to ban growth-promoter (or “feed efficiency”) use of antibiotics. What it does appear to do, though, is require the FDA to follow through on a process that it began in 1977, when the agency was so concerned over the safety of using penicillin and tetracycline drugs in livestock feed that it called hearings to examine withdrawing its approval of using the drugs in animals.

Because of pressure, largely from certain Congressmen, those hearings were never held.

From the order by Magistrate Judge Theodore H. Katz (which I have confirmed has been filed in PACER, the US Courts’ electronic-document system, US Court for the Southern District of New York, case 1:11-cv-03562-THK. Update: I put a copy up at my Scribd account.):

Defendants are hereby ordered to initiate withdrawal proceedings for the relevant NADAs / ANADAs [m: “new animal drug application”/”abbreviated new animal drug application”, for generics]. Specifically, the Commissioner of the FDA or the Director of the CVM [m: Center for Veterinary Medicine] must re-issue a notice of the proposed withdrawals (which may be updated) and provide an opportunity for a hearing to the relevant drug sponsors; if drug sponsors timely request hearings and raise a genuine and substantial issue of fact, the FDA must hold a public evidentiary hearing. If, at the hearing, the drug sponsors fail to show that use of the drugs is safe, the Commissioner must issue a withdrawal order.

The Court notes the limits of this decision. Although the Court is ordering the FDA to complete mandatory withdrawal proceedings for the relevant penicillin and tetracycline NADAs/ANADAs, the Court is not ordering a particular outcome as to the final issuance of a withdrawal order. If the drug sponsors demonstrate that the subtherapeutic use of penicillin and/or tetracyclines is safe, then the Commissioner cannot withdraw approval.

This order is potentially very significant — it moves the debate on agricultural use of antibiotics from the FDA’s current strategy of voluntary participation, and some regulation, into legal requirements. But the history behind it is quite complex. Here are some links:

The coalition that brought the suit is led by the Natural Resources Defense Council; other plaintiffs are the Center for Science in the Public Interest, Food Animal Concerns Trust, Union of Concerned Scientists, and Public Citizen.

More to come on this; that’s all for tonight.



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