Source: http://www.fdalawblog.net/2012/03/nonprofit-groups-prevail-in-lawsuit-against-fda-over-subtherapeutic-uses-of-penicillin-and-tetracycl/
Timestamp: 2019-04-20 09:10:55+00:00

Document:
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.
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 . . . .
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.
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).
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.

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