On March 22, 2012, the United States District Court for the Southern District of New York issued an order that requires FDA to continue withdrawal proceedings under the Food Drug and Cosmetics Act, 21 U.S.C. § 360b(e), for sub-therapeutic use of certain antibiotics in livestock, including cattle, poultry, and seafood. The court found that the lawsuit was authorized by the Administrative Procedure Act (“APA”) because the new animal drug withdrawal process is a discrete action that FDA was required by statute to take. In addition, the court found that when FDA determines that there are “serious questions” about the safety of a drug, then FDA is required under § 360b(e)(1) to withdraw approval of the drug unless the drug sponsors can prove that the drug is safe. Therefore, the court ordered FDA to re-issue a notice of withdrawal for penicillin and tetracyclines (chlortetracycline and oxytetracycline) in animal feed and provide an opportunity for a hearing to the relevant drug sponsors. If the drug sponsors fail to show that the drug use is safe, FDA must issue a withdrawal order.
FDA originally began proceedings to withdraw approval for antibiotics in 1973 after a task force comprised of scientists from FDA, NIH, USDA, CDC and representatives from universities and industry concluded that the use of antibiotics in feed favors development of antibiotic resistant bacteria and that such development was already happening. FDA provided drug sponsors an opportunity to submit data to support sub-therapeutic use of antibiotics and, after a review of the data, the Bureau of Veterinary Medicine (“BVM”) issued notices of an opportunity for hearing on proposals to withdraw approval of sub-therapeutic uses of penicillin, oxytetracycline and chlortetracycline in 1977. At the hearings, the drug sponsors would have the burden of proving that the drugs are safe for their intended use. Twenty organizations requested hearings but the hearings were never scheduled.
After receiving no response on two Citizen Petitions requesting follow-through on the 1977 notices, the Natural Resource Defense Council (“NRDC”), along with several other non-profit organizations, filed suit in federal court alleging that the FDA withheld agency action in violation of § 360b(e) and the APA, 5 U.S.C. § 706(l). § 360b(e)(1) states that FDA “shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application” if FDA finds that a drug is not shown to be safe for its intended use. NRDC argued that once BVM found that the sub-therapeutic use of antibiotics was not shown to be safe, FDA was obligated under § 360b(e)(1) to withdraw approval of the use, unless the drug sponsors met their burden of proving the antibiotics’ safety. Failure to do so, NRDC argued, constituted an “agency action unlawfully withheld or unreasonably delayed,” for which § 706(l) provides relief.
FDA argued that the relief sought by NRDC was unavailable under the APA because a withdrawal process was not a discreet agency action. In previous cases, the Supreme Court found that § 706(l) “only applies when ‘an agency failed to take a discrete action that it is required to take.’” According to FDA, the relief sought by NRDC was not discrete because issuing a notice and holding hearings is a complex process that could take “months or years to complete.” In addition, FDA argued that the statutory obligation to withdraw approval is not triggered until the FDA makes a finding after a formal hearing and that the finding had to be made by the Secretary, not a bureau chief.
The court noted that “[t]he fact that §360b(e)(1) requires notice and an opportunity for a hearing prior to the issuance of a withdrawal order does not undermine the fact that the requested relief is a discrete agency action.” The court acknowledged that the FDCA does not explicitly state the order in which the withdrawal process must occur, but found that § 360b(e)(1):
only requires the Secretary to give notice and provide an opportunity for a hearing before issuing an order of withdrawal and not before making the findings. Under this reading, if the Secretary finds that an animal drug has not been shown to be safe, he is statutorily required to withdraw approval of that drug, provided that the drug sponsor has notice and an opportunity for a hearing. If, after a hearing, the drug sponsor has not met his burden of proving the drug to be safe, the Secretary must issue a withdrawal order.
In response to FDA’s assertion that only the Secretary can issue a withdrawal order, the court noted that the Secretary of Health and Human Services delegated to the FDA Commissioner all authority vested in him by the FDCA and the Commissioner, in turn, delegated authority to issue notices of opportunity for hearing on animal drug withdrawals to the Director of BVM. “By authorizing the Director to issue notices of an opportunity for a hearing, the Commissioner necessarily authorized the Director to make the findings on which such notices of withdrawal are based.” The court ordered FDA to proceed with the hearings but did not specify a timeline as requested by NRDC.