Natural Resources Defense Council, Inc., et al., v. United States Food and Drug Administration, et al., (S.D.N.Y. March 22, 2012) (1:11-cv-03562-THK)

Online copy: HERE

Background: In 1977 the FDA issued notices announcing its intent to withdraw approval of the use of certain antibiotics in livestock for the purposes of growth promotion and feed efficiency because the practice had not been found by the FDA to have been proven to be safe. Until the filing of the lawsuit by the Natural Resources Defense Council on May 25, 2011 the FDA had done nothing with respect to the notices for thirty years. During that time, research continued to show that the use of sub-therapeutic antibiotics on animals was either unsafe or that the use was not proven to be safe. In fact, the court noted that:

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 through direct contact, environmental exposure, and the consumption and handling of contaminated meat and poultry products.

It appears to be clear that the FDA did not collect any substantive research data that justified reversing the withdrawal process. The NRDC lawsuit alleged that the FDA’s thirty-year delay constituted a violation of the APA and the FDCA and asked that the court order the FDA to withdraw approval of the drugs for sub-therapeutic purposes.

In December of 2011 the FDA responded to the NRDC lawsuit by withdrawing the notices. In response to a motion for summary judgment filed by NRDC, the FDA argued that the lawsuit was now moot. In doing so, the FDA did not allege that the withdrawal of the notices was based on any reversal of the original 1977 findings that the drugs were not proven to be safe.

Discussion: The Judge first disposed of the FDA’s mootness argument. The Judge held that by withdrawing the notices without any change in the underlying findings that the FDA was violating the law. Although the FDA pointed to a new guidance document that it had drafted in 2010 to deal with microbial food safety issues, the Judge noted that non-binding guidance documents and other policy documents do not take the place of administrative action mandated by the statute. The court concluded that the withdrawal “does not absolve the agency of its statutory duty to initiate and complete withdrawal proceedings.”

The court’s ruling is silent on the issue of whether the FDA had any other defense other than mootness. The court therefore had no problem concluding that the FDA had to proceed with its procedure to withdraw the drugs. The court held:

Defendants are hereby ordered to initiate withdrawal proceedings for the relevant NADAs / ANADAs . Specifically, the Commissioner of the FDA or the Director of the CVM 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 ended the opinion by noting that it was not mandating any particular outcome and added that the drug companies had a right to a hearing where they could try to prove that the sub-therapeutic uses of the drugs were safe.