Arbitrary and Ironic
The Natural Resources Defense Council (NRDC) sued the FDA on behalf of the petitioners early last year, first to force the agency to respond to the
petitions and then, when the agency denied both, to require the FDA to reconsider the petitions on their scientific merits, not whether the agency believes
it has enough time to do the right thing.
In court, the agency seemed to contest almost every point except the science. More than anything, the FDA reiterated the arguments it made when it denied
the petitions: withdrawing approvals takes too much time and it hopes industry will voluntarily withdraw the approvals anyway. The agency never disputed
what is well known: many current uses of antibiotics in food animal production pose a major public health threat.
The Court was not persuaded by these arguments. In a sharply worded opinion, the judge noted that although the petitions, accompanied by more than 3,000
pages of research and other documentation, contain "numerous scientific studies of the risks of antibiotic resistance from the use of antibiotics in
food-producing animals, the Agency did not address or even mention the scientific evidence in its responses." The FDA had failed to meet the requirements
of federal law, under which a "decision whether to initiate formal withdrawal proceedings must be based on an evaluation of the scientific evidence of a
The judge seemed impatient with FDA's arguments that withdrawing approvals "would take many years," calling this argument "ironic and arbitrary" as the
agency had essentially ignored the two petitions for 12 and seven years, respectively. "Had the Agency addressed the Petitions in a timely fashion," he
wrote, "withdrawal proceedings could have been commenced and completed by now."
Furthermore, the FDA's reliance on a voluntary program undercut its claim that the withdrawal process would be too time-consuming for the agency to
undertake. "[If] any credence is to be given to the Agency's position that the drug industry intends to comply with the voluntary program, then it is
unclear why the industry would contest formal withdrawal notices or require time consuming hearings."
The judge ordered the agency to reconsider both petitions, this time on their merits. Importantly, the Court did not order the FDA to reach a certain
conclusion, only to base whatever decision it makes on the available scientific evidence. Both petitions make strong cases that using antibiotics for
growth promotion and disease prevention does not meet the standard for safety set by law. If the FDA agrees--and one wonders how the agency cannot--the law
requires it to withdraw approvals for such uses.
Last week the agency gave notice it would appeal the March ruling on penicillins and tetracyclines, and it will almost certainly do the same with the
latest decision. If the NRDC and the petitioners win on appeal, the FDA may still find ways to deny the petitions yet again, although this will be hard to
do if the agency takes a careful look at the science. Despite the challenges that lie ahead, however, the court decision this week was welcome news. The
ruling puts the focus back on science--where it should have been all along.