Nonprofit Groups Prevail in Lawsuit Against FDA Over Subtherapeutic Uses of Penicillin and Tetracyclines in Animal FeedMarch 27, 2012
By Kurt R. Karst –
In a decision that if left intact could have far-reaching implications for FDA, the U.S. District Court for the Southern District of New York recently granted a Motion for Summary Judgment filed by the National Resources Defense Council (“NRDC”) and three other member groups of “Keep Antibiotics Working” (a coalition of health, consumer, agricultural, environmental, humane and other advocacy groups) – the Center for Science in the Public Interest, the Food Animal Concerns Trust and the Union of Concerned Scientists – and denied FDA’s Cross-Motion for Summary Judgment in a case concerning the withdrawal of approval for subtherapeutic uses of penicillin and tetracyclines in animal feed.
As we previously reported, the NDRC, et al. filed a Complaint in May 2011 seeking to compel FDA, by a court-ordered deadline, to withdraw approval for subtherapeutic uses of penicillin and tetracyclines in animal feed and to issue a final response to two Citizen Petitions submitted to the Agency – one on March 9, 1999 (Docket No. FDA-1999-P-1286) and another on April 7, 2005 (Docket No. FDA-2005-P-0007). Both petitions relate to Notices of an Opportunity for Hearing (“NOOHs”) FDA issued in 1977 on proposals to withdraw approval of all subtherapeutic uses of penicillin in animal feed and nearly all subtherapeutic uses of tetracyclines (oxytetracycline and chlortetracycline) in animal feed because of a threat to human health. Although hearings were requested, FDA never held them or otherwise took action on the proposed withdrawals.
FDA, on the Agency’s own initiative, denied both petitions on November 7, 2011 (here and here) (just one day before FDA’s response to NDRC’s Motion for Summary Judgment was due) saying in both responses that “for various reasons the Agency has decided not to institute formal withdrawal proceedings at this time and instead is currently pursuing other alternatives to address the issue of antimicrobial resistance related to the production use of antimicrobials in animal agriculture.” One of those “other alternatives” is laid out in FDA’s June 2010 draft guidance No. 209 – The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals – which FDA says provides “a pathway to achieving the same goals as those advocated by [Plaintiffs], i.e., judicious use of medically important antimicrobials.” The draft guidance provides a “framework for policy regarding the appropriate or judicious use of medically important antimicrobial drugs in food-producing animals,” including “1) limiting medically important antimicrobial drugs to uses in food-producing animals that are considered necessary for assuring animal health; and 2) limiting such drugs to uses in food-producing animals that include veterinary oversight or consultation.”
Several weeks after denying the 1999 and 2005 citizen petitions, FDA, on December 22, 2011, issued a Federal Register notice withdrawing the 1977 NOOHs saying, among other things, that “FDA is engaging in other ongoing regulatory strategies developed since the publication of the 1977 NOOHs with respect to addressing microbial food safety issues.” As FDA did in the citizen petition denials, the Agency referenced draft guidance No. 209, saying that it represents a “pathway to achieving the same goals contemplated by the 1977 NOOHs.” FDA also commented that notwithstanding the NOOH withdrawals, the Agency “remains concerned about the issue of antimicrobial resistance.”
Undeterred by FDA’s actions, the NRDC promptly alleged that FDA withheld agency action in violation of both the Administrative Procedure Act (“APA”) (5 U.S.C. § 706(1)) and FDC Act § 512(e)(1), which states (similar to its NDA counterpart at FDC Act § 505(e)(1)) in relevant part that FDA:
shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application filed pursuant to [FDC Act § 512(b)] with respect to any new animal drug if the Secretary finds . . . . (B) that new evidence not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved . . . .
After initially determining that FDC Act § 512(e)(1) requires FDA to take certain “discrete actions” subject to APA review, U.S. Magistrate Judge Theodore H. Katz addressed in his 55-page decision whether FDA is legally required to proceed with the NOOH hearing and withdrawal process. In a resounding “yes” to this question, Magistrate Judge Katz wrote in his opinion that:
Here, the statute unambiguously commands the Secretary to withdraw approval of any new animal drug that he finds not shown to be safe, provided that the sponsor of the animal drug has notice and an opportunity for a hearing. The statute does not explicitly state the order in which this process must occur.
FDA contended that the Secretary can only issue a finding after a hearing, while the NRDC contended that FDA’s obligation to provide notice and opportunity for a hearing is triggered by the Agency’s initial finding. Magistrate Judge Katz found the Plaintiffs’ interpretation more palatable:
The Court finds that Plaintiff’s interpretation provides a common sense reading of the statute based on its text and grammatical structure. The statute states that “[t]he Secretary shall after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of a [NADA/ANADA] if the Secretary finds . . . [that a drug is not shown to be safe] . . . .” The “after due notice and opportunity for hearing” clause is setoff by commas and immediately precedes the words “issue an order withdrawing approval,” indicating that the “notice” clause modifies the “issue an order” clause and not the findings clause. Accordingly, the statute only requires the Secretary to give notice and provide an opportunity for a hearing before issuing an order of withdrawal and not before making 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. [(Internal citations omitted)]
Magistrate Judge Katz wrote in his opinion that a decision that FDC Act § 512(e)(1) requires FDA to issue notice and an opportunity for a hearing whenever the Agency finds that a new animal drug is not shown to be safe is consistent with how courts, including the U.S. Supreme Court in FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 134 (2000), have interpreted the NDA counterpart provisions at FDC Act § 355(e). See Mylan Labs., Inc. v. Thompson, 389 F.3d 1272, 1281 (D.C. Cir. 2004), Dobbs v. Wyeth Pharms., 797 F. Supp. 2d 1264, 1270-71 (W.D. Okla. 2011).
In ordering FDA to initiate withdrawal proceedings for the relevant NADAs and ANADAs, Magistrate Judge Katz was careful to note the limits of his decision, stating: “Although the Court is ordering the FDA to complete mandatory withdrawal proceedings for the relevant penicillin and tetracycline NADAs/ANADAs, the Court is not ordering a particular outcome as to the final issuance of a withdrawal order. If the drug sponsors demonstrate that the subtherapeutic use of penicillin and/or tetracyclines is safe, then the Commissioner cannot withdraw approval.”
The district court decision was almost immediately hailed by Representative Louise Slaughter (D-NY) in a press release as a “landmark decision.” As we previously reported, Rep. Slaughter, who is the only microbiologist in Congress, has shown a keen interest in FDA’s action (or lack thereof) related to antibiotic use in animal agriculture. Rep. Slaughter is the author of the Preservation of Antibiotics for Medical Treatment Act, which would, among other things, phase out the non-therapeutic use in livestock of medically important antibiotics.
FDA has not yet indicated whether or not the Agency will appeal Magistrate Judge Katz’s decision. We’d be a bit surprised if the Agency decides not to appeal given FDA’s likely view that it intrudes on the Agency’s ability to set regulatory priorities. Moreover, the decision, if not appealed (or if affirmed on appeal), could open the door for third parties to seek a court order to compel FDA to initiate withdrawal proceedings for a particular drug product, provided the precursors that exist in this case exist in another case.