Astrazeneca Pharmaceuticals LP v. Burwell et al

RESPONSE re MOTION to Modify Court's Order

D.D.C.July 14, 2016

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA ASTRAZENECA PHARMACEUTICALS LP; IPR PHARMACEUTICALS, INC., Plaintiffs, v. SYLVIA MATHEWS BURWELL, Secretary of Health & Human Services; ROBERT CALIFF, Commissioner of Food and Drugs; FOOD AND DRUG ADMINISTRATION, Defendants, and PAR PHARMACEUTICAL, INC.; APOTEX CORP.; APOTEX INC.; SANDOZ INC.; SUN PHARMA GLOBAL FZE; SUN PHARMACEUTICALS INDUSTRIES INC.; GLENMARK PHARMACEUTICALS INC. USA; GLENMARK PHARMACEUTICALS LTD.; AUROBINDO PHARMA LIMITED; AUROBINDO PHARMA USA, INC. Intervenor-Defendants. Civ. No. 16-cv-1336 (RDM) FEDERAL DEFENDANTS’ REPONSE TO PLAINTIFFS’ MOTION TO MODIFY THIS COURT’S MEMORANDUM AND ORDER TO GOVERN WEEKEND PROCEEDINGS Plaintiffs have moved this Court to modify its Scheduling Order (Dkt. No. 52) in two respects: (1) modify Section 4 of the Order “to provide that counsel shall be prepared to appear for a Saturday or Sunday hearing on six hours’ notice, as opposed to two hours’ notice,” and (2) require “FDA to advise the parties and the Court if FDA Case 1:16-cv-01336-RDM Document 65 Filed 07/14/16 Page 1 of 4 determines by 5:00 p.m. ET on Thursday of a given week that it will not be issuing a decision on the pending citizen petition before the following Monday at 10:00 a.m. ET.” (Pls’ Mot. to Modify This Court’s Mem. and Order to Govern Weekend Proceedings (Pls.’ Mot.), at 1 (Dkt. No. 64)). The Federal Defendants oppose this motion. First, as the Plaintiffs note, the Federal Defendants have already provided assurance to Plaintiffs that “FDA generally does not issue decisions on weekends and it does not intend to issue a decision in this case over the weekend.” (Pls.’ Mot. at 3.) Plaintiffs’ complaint that the Federal Defendants “ha[ve] not said whether this case could be an exception” to this practice ignores the plain language of FDA’s statement. Further, Plaintiffs never requested such a clarification, which the Federal Defendants would have provided. Thus, the relief Plaintiffs request is unnecessary and their motion should be denied on this basis. Second, alerting the parties to FDA’s decision timetable would put it afoul of regulations governing confidentiality of ANDAs. See 21 U.S.C. § 331(j); 21 C.F.R. § 20.61; 21 C.F.R. § 314.430. The Court implicitly recognized this when it rejected Plaintiffs’ earlier request for 48 hour advanced notice of a decision. The Federal Defendants will more fully apprise the Court of the status of its review of Plaintiffs’ Citizen Petition on an ex parte basis should the Court request. Case 1:16-cv-01336-RDM Document 65 Filed 07/14/16 Page 2 of 4 Dated: July 14, 2016 Respectfully submitted, BENJAMIN C. MIZER Principal Deputy Assistant Attorney General JONATHAN F. OLIN Deputy Assistant Attorney General MICHAEL S. BLUME Director ANDREW CLARK Assistant Director /s/ Charles J. Biro Of Counsel: MARGARET M. DOTZEL Acting General Counsel U.S. Dept. of Health & Human Services ELIZABETH H. DICKINSON Chief Counsel Food and Drug Administration ANNAMARIE KEMPIC Deputy Chief Counsel, Litigation ANN M. OXENHAM Associate Chief Counsel for Enforcement U.S. Dept. of Health & Human Services Office of the General Counsel Food and Drug Division 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Tel: (301) 796-8710 ann.oxenham@fda.hhs.gov Charles J. Biro Illinois Bar No. 6277139 Trial Attorney Consumer Protection Branch Civil Division United States Department of Justice P.O. Box 386 Washington, DC 20044 202-307-0089 Charles.Biro@usdoj.gov Case 1:16-cv-01336-RDM Document 65 Filed 07/14/16 Page 3 of 4 CERTIFICATE OF SERVICE I certify that a copy of this pleading was filed via the Court’s CM/ECF system and served on the attorneys of record for all parties via the Court’s CM/ECF system. /s/ Charles J. Biro Charles J. Biro United States Department of Justice Case 1:16-cv-01336-RDM Document 65 Filed 07/14/16 Page 4 of 4