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From Health Law Daily, July 25, 2014

FDA not required to withdraw ‘unsafe’ animal drugs

By Bryant Storm, JD

The Second Circuit sided with the FDA in a dispute over when the FDA is required to withdraw approval for a drug’s use after the FDA has identified the use as being unsafe. The challenge, brought by a group of advocacy organizations, alleged that the FDA was obligated to hold a withdrawal hearing to withdraw the use of antibiotics in animal feed because the FDA had made a finding that the particular use was unsafe for humans. The court held that although the hearing process was ambiguously set out in 21 U.S.C. 360b(e)(1), the FDA had interpreted the statute correctly and was not required to hold a hearing or withdraw antibiotics from use in animal feed (Natural Resources Defense Council, Inc. v U.S. Food and Drug Administration, July 24, 2014, Lynch, G).

Animal feed. The FDA regulates animal drugs under the federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. sec. 360b(a)(1)). In keeping with those regulatory responsibilities, in 1961, the FDA first identified concerns about the subtherapeutic use of antibiotics in animal feed, which refers to the non-medical use of antibiotics to encourage faster, healthier growth of animals. The concerns stemmed from a growing awareness that the use of antibiotics in animal feed leads to strains of antibiotic-resistant bacteria that can be transferred to humans. Through the consumption of animal meat, humans can develop a resistance to antibiotics, which poses a substantial risk to human health. In 1977, in response to a growing array of information corroborating those concerns, the FDA issued two notices of opportunity for hearing (NOOH) for two types of antibiotics: penicillin and tetracyclines. The hearings were intended to evaluate whether approval of those drugs for use in animal feed should be altered or withdrawn altogether. The FDA never held the hearings.

Hearings. Instead of holding the hearings or withdrawing the use of antibiotics in animal feed, the FDA passed several draft guidance documents, hoping that industry and drug manufacturers would voluntarily curb their use of antibiotics in animal feed. The Natural Resources Defense Council, Inc., the Center for Science in the Public Interest, the Food Animal Concerns Trust, Public Citizen, Inc., and the Union of Concerned Scientists, Inc. filed suit against the FDA in May, 2011, challenging the FDA’s refusal to hold the hearings and for failing to respond to two petitions, from 1997 and 2005, which requested the withdrawal of antibiotics form their use in animal feed. The FDA responded by denying the petitions. The advocacy organizations then filed an amended complaint contending the denial of the petitions was arbitrary and capricious.

District court. The district court held that 21 U.S.C. 360b(e)(1) required the FDA to hold a withdrawal hearing when it made a finding that a particular drug was not safe. The district court reasoned that the FDA made such a finding when it issued the 1977 NOOHs. The court also held that the petitions were arbitrarily denied because the hearings they asked for, which the FDA never held, were mandatory as a result of the FDA finding that the use of antibiotics in animal feed was unsafe.

Ambiguous. The Second Circuit began its analysis by acknowledging that the procedures which governed the FDA’s obligation to hold a withdrawal hearing, as set out in section 360b(e)(1), were ambiguous. However, the court quickly acknowledged that the FDA’s interpretation of that section was the only practical or proper one. Thus, the court held that section 360b(e)(1) only required the FDA to withdraw a drug from use after it had made a finding that the drug’s use was unsafe. Notably, the court held that such a finding could only could occur after a withdrawal hearing was held and that the decision to hold such a hearing was solely within the FDA’s discretion.

Practicality. The court rejected the advocacy organizations’ position that the FDA’s internal finding gave rise to a requirement to hold a hearing and withdraw a drug because that interpretation was unworkable in the court’s eyes. The court held that the organizations’ position would have required the FDA internal finding to have been embodied somewhere. The formal finding could not have been the NOOH, because, by the time of the lawsuit, the NOOHs had been withdrawn. The court refused to accept the potential outcome that the formal finding, which initiated the statutory requirement for a withdrawal hearing, could have existed in the mind or opinion of the FDA Secretary or Commissioner. The court reasoned that the advocacy groups’ position, which rested on an unworkable notion of a finding, was too “metaphysical” for practical purposes.

Discretion. Additionally, the court held that it was obligated to adopt the FDA interpretation to allow for agency discretion to determine with which withdrawals to go forward. The court reasoned that a contrary interpretation would undermine the discretion to which the FDA is entitled under the Administrative Procedure Act (APA) (5 U.S.C. sec. 701(a)(2)).

Arbitrary. The court also determined that the FDA’s withdrawal of the NOOHs, denial of the petitions, and refusal to hold a hearing was not arbitrary and capricious, in violation of 5 U.S.C. sec. 706(2)(A), because the FDA set out specific reasons for its withdrawal and acted upon its discretion to work with the animal drug industry to limit the use of antibiotics in feed. The court held that the decision as to how the use of antibiotics in animal feed should be resolved was best left to the expertise of the FDA and not to judges.

Ultimately, the court determined that the FDA was not required to hold a withdrawal hearing and then withdraw an approved drug every time it developed “scientific concerns about the safety of animal drug use.” The court decided that the FDA was entitled to more discretion than the dissent or the advocacy groups would have given the FDA. The Second Circuit remanded the case to the district court so that judgment could be granted in the FDA’s favor and the case could be dismissed.

Dissent. The Second Circuit’s Chief Judge, Theodore Katzmann, dissented from the majority opinion on the ground that the FDA had, for nearly four decades, maintained the position that the subtherapeutic use of penicillin and tetracyclines in animal feed was unsafe. Judge Katzmann reasoned that despite the FDA’s self-avowed position that the use of antibiotics in animal feed could lead to the development of antibiotic-resistant bacteria and a subsequent public health problem on a global scale, the FDA had “refused to move forward with the statutorily-prescribed process for withdrawing approval from the subtherapeutic use” of those drugs.

Hypocrisy. Judge Katzmann criticized the majority for allowing a seemingly hypocritical paradigm in which the FDA is permitted to declare a drug unsafe and then refuse to withdraw approval for that drug. The dissent also criticized the result of allowing the FDA to, in effect, ignore multiple public petitions asking it to consider withdrawing approval for a drug that is known to be unsafe. Judge Katzmann saw the advocacy groups’ reading of section 360b(e)(1) as reasonable and more practical than the FDA interpretation because an outcome that allowed the FDA to leave an unsafe drug on the market could not be reconciled with the purpose of the FDA or the requirement of the FDC Act. Additionally, Judge Katzmann criticized the majority opinion for mischaracterizing the advocacy groups’ argument, which did not read section 360b(e)(1) to require the FDA to withdraw a drug immediately upon a finding that it was unsafe, but, instead, only required that such a finding would obligate the FDA to move forward with the withdrawal process.

The case numbers are 12-2106-cv(L), 12-3607-cv(CON).

Attorneys: Mitchell S. Bernard, Natural Resources Defense Council, Inc., for Natural Resources Defense Council, Inc., Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, Inc., Union of Concerned Scientists, Inc. Sarah Sheive Normand, Office of the U.S. Attorney for the Southern District of New York, for Margaret Hamburg, Commissioner, U.S. Food and Drug Administration, Bernadette Dunham, Director, Center for Veterinary Medicine, Secretary, U.S. Department of Health and Human Services,

Companies: Natural Resources Defense Council, Inc.; Center for Science in the Public Interest; Food Animal Concerns Trust; Public Citizen, Inc.; Union of Concerned Scientists, Inc.; U.S. Food and Drug Administration; Center for Veterinary Medicine; U.S. Department of Health and Human Services

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