[T]he Commissioner of the FDA or the Director of the [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 comments to this report raise the predictable issue of whether small-government types should be up in arms or not. It's a good question. CAFOs (concentrated animal feedlot operations) are pretty horrifying from a number of points of view, not least the impact on public health. Is this one of the areas where even libertarians should welcome regulatory interference?
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.
Nevertheless, somehow I don't see the FDA issuing a prohibition of livestock antobiotics any time soon. Much as I'd prefer to see meat raised to Joel Salatin's or Michael Pollan's standards, the bulk of our meat comes from CAFOs. No one's going to get away with shutting that industry down overnight. You think high gas prices are going to be a headache in the November elections, wait till all meat goes for pasture-raised organic prices. And what would we do with all that subsidized corn? The animals can't be fed on a pure diet of corn for months without prophylactic antiobiotics to keep it from killing them before they're fattened up.