The antibiotic trial of the century

The Natural Resources Defense Council won a motion yesterday in federal district court in the southern district of New York (pdf here) on the safety of antibiotics used on the farm in sub-therapeutic doses for growth promotion. The FDA approved these practices in the 1950s, but for decades researchers have raised human safety concerns.  From the opinion:

The administration of “medically important” antibiotics to entire herds or flocks of food-producing animals at “subtherapeutic levels poses a qualitatively higher risk to public health than the administration of such drugs to individual animals or targeted groups of animals to prevent or treat specific diseases.  Research has shown that the use of antibiotics in livestock leads to the development of antibiotic-resistant bacteria that can be and has been transferred from animals to humans …  Consequently, the FDA has concluded that “the overall weight of evidence available to date supports the conclusion that using medically important antimicrobial drugs for production purposes [in livestock] is not in the interest of protecting and promoting the public health.” (at 4-5)

The FDA has been worried about this problem since the mid-1960s, but has held off many regulatory moves in deference to the political power of agribusiness. This opinion forces the FDA to move forward with a process stalled since the 1970s, holding a hearing to decide whether sub-therapeutic uses of antibiotics in farm animals are “safe.”  If not, the Food, Drug and Cosmetics Act requires the FDA to withdraw approval for the drug’s use.  21 USC 360b(e)(1).  From the opinion:

Defendants are hereby ordered to initiate withdrawal proceedings for the relevant NADAs/ANADAs [animal drugs]. Specifically, the Commissioner of the FDA or the Director of the CVM [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, at the hearing, the drug sponsors fail to show that the use of the drugs is safe, the Commissioner must issue a withdrawal order. (at 54)

Some caveats:  this is from a Magistrate Judge, not an Article III Judge. The FDA has many procedural grounds for an appeal and further litigation.

But if the FDA is truly worried about the human health risk of antimicrobial resistance, perhaps they should forgo the appeals and comply with the order. The resulting hearings would put the sub-therapeutic use of antibiotics on trial, which might be a good thing for both science and public health. More info:

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