FDA has now appealed the two victories we won earlier this year concerning the use of antibiotics in livestock. A federal district court ruled in March and June that FDA must take stronger action than it has so far—by stopping the non-therapeutic use of penicillin and tetracyclines in livestock unless drug manufacturers prove the safety of such use and by confronting the science on the safety of non-therapeutic use of other medically important antibiotics in animal feed and water in response to citizen petitions. FDA has asked the United States Court of Appeals for the Second Circuit to overturn both decisions so that FDA need not take either action and we are in the midst of briefing the issue for the court.
So, I was more than a little surprised to see FDA claim in a recent letter to Representative Slaughter of New York that it intends to “comply with the [district] Court’s order, subject to any modifications the Court or an appellate court may impose in the future.” FDA is not just seeking a modification to the orders; it has asked the Second Circuit to set them aside.
FDA also writes that its “recent actions”— i.e. FDA’s problematic voluntary program for industry discussed here at greater length—are “not intended to conflict” with the district court’s decision. As I have noted before, the district court wrote in its June opinion that
“the statutory scheme requires the Agency to ensure the safety and effectiveness of all drugs sold in interstate commerce, and, if an approved drug is not shown to be safe or effective, the Agency must begin withdrawal proceedings. The Agency has forsaken these obligations in the name of a proposed voluntary program, Guidance # 209, and acted contrary to the statutory language.”
Oddly enough, FDA also writes in a footnote that the Department of Justice filed the appeal of the decision concerning the citizen petitions. While the Department of Justice filed the appeal, surely FDA, as the client, directed it to do so. It is curious that FDA appears to be distancing itself from the appeals even as it moves forward with them.
NRDC remains fully engaged in the litigation and is moving forward with making our case before the Second Circuit. Written briefing on the appeal is slated to be completed by November 20.