Caretolive v. Von Eschenbach, 2:07-cv-729.

CourtUnited States District Courts. 6th Circuit. United States District Courts. 6th Circuit. Southern District of Ohio
Citation525 F.Supp.2d 938
Docket NumberNo. 2:07-cv-729.,2:07-cv-729.
PartiesCARETOLIVE, Plaintiff, v. Andrew von ESCHENBACH, et al., Defendants.
Decision Date21 November 2007

Kerry M. Donahue, Bellinger & Donahue, Dublin, OH, for Plaintiff.

Mark Thomas D'Alessandro, John J. Stark, United States Attorney's Office, Columbus, OH, Andrew Clark, Daniel K. Crane-Hirsch, Office of Consumer Litigation, Washington, DC, for Defendants.

OPINION AND ORDER

GREGORY L. FROST, District Judge.

This action involves a biologics "license application ("BLA") that was submitted to the Food and Drug Administration ("FDA") for Provenge, a biological product which is intended to treat a particular type of metastatic prostate cancer and is manufactured by Dendreon Corporation. Plaintiff CareToLive challenges the decision of the FDA "not to approve Provenge for immediate use and instead [to] issue[] a Complete Response Letter requesting more data." (Doc. # 22.) This matter is before the Court on Defendants' Motion to Dismiss Plaintiff's Official Capacity Claims (Doc. # 38) and on Defendants' Motion to Strike Improper Supplemental Memorandum (Doc. # 59). For the reasons that follow, the Court GRANTS both of Defendants' motions.

I. BACKGROUND
A. The Parties

Plaintiff characterizes itself as an association of "cancer patients, patient families, doctors, investors, and advocates." (Doc. # 22 at 2.) Plaintiff brought this action against the Commissioner of the FDA Andrew von Eschenbach,. M.D., and the. Secretary of the United States Department of Health and. Human Services Michael Leavitt, in their official capacities and against Richard Pazdur, M.D. and Howard Scher, M.D., in both their official and individual capacities.1 Id. ¶¶ 4, 5, 6, 7. Pazdur is the Director of the Office of Oncologic Drug Products in the FDA's Center for Drug Evaluation and Research. Id. ¶ 6. Scher is a special government employee who served on the FDA Advisory Committee that considered the, Provenge BLA. Id. ¶ 7.

B. Statutory and Regulatory Scheme

Biological products are defined under the Public Health Service Act ("PHSA") as any "virus, therapeutic serum, toxin, antitoxin, vaccine ... or analogous product ... applicable to the prevention, treatment, or cure of a disease or condition of human beings." 42 U.S.C. § 262(i). Biological products' can also be drugs, and are generally subject to the same statutory and regulatory requirements that apply to drugs. See 42 U.S.C. § 262(j) (the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 321, applies to biological products subject to regulation under the PHSA, 42 U.S.C. § 262).

The FDCA defines "drug" to include, inter alia, "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man...." 21 U.S.C. § 321(g)(1)(B). A "new drug" is defined as either (1) a drug that is "not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof," or (2) a drug that, "as a result of investigations to determine its safety and effectiveness for use under such conditions, hap become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions." 21 U.S.C. § 321(p).

1. Biological Product Approval Process

For unapproved biological products, the sponsor seeks FDA approval by submitting a BLA pursuant to the PHSA. 42 U.S.C. § 262(a). The FDA will approve a BLA for an unapproved biological product if the BLA demonstrates that the product is safe, pure, and potent, id. § 262(a)(2)(C)(i)(I), and that the facility in which the product is manufactured "meets standards designed to assure that the biological product continues to be safe, pure, and potent," id. § 262(a)(2)(C)(i)(II).

Generally, when the sponsor of a biological product has completed the clinical trial process, it can submit a BLA in accordance with 21 C.F.R. § 601.2(a). The required documentation in a BLA provides information for the FDA evaluation of the biological product, including the results of clinical trials, the composition of the drug, manufacturing information, and sample labeling. Id. The FDA will not consider a BLA to be filed until all pertinent data have been received by the agency. See id.

2. FDA Responses to a BLA

In response to a BLA, the FDA may refuse to file it if it is incomplete. See FDA, "Refusal to File Procedure for Biologics License Applications," SOPP 8404, available at http://www.fda.gov/cber/ regsopp/8404.htm. Further, under certain circumstances the FDA will approve a BLA, 21 C.F.R. § 601.4(a), or deny it and provide the applicant the opportunity for a hearing, id. § 601.4(b). Finally, if there are deficiencies in the BLA, the FDA may send a Complete Response Letter declining to approve the BLA as it was presented and requesting additional information from the sponsor. Applications for Approval to Market a New Drug, 69 Fed. Reg. 43351, 43352 (July 20, 2004) (to be codified at 21 C.F.R. §§ 314.110, 314.120),

C. Statement of Facts

Provenge is a biological product intended to treat a particular type of metastatic prostate cancer. (Doc. # 22 ¶ 15.) Provenge uses a patient's own cells to prepare a final product designed, for infusion back into the patient's bloodstream to activate his or her immune system against the cancer cells. Id. ¶¶ 14, 16. Provenge is referred to as an active cellular immunotherapy, designed to elicit a patient's specific immune response to a target antigen expressed in prostate cancer tissue, i.e., to train a patient's immune system to recognize cancer cells and to fight them. Id. ¶¶ 14-16, 19. Because it is designed to act in this manner, Provenge is a vaccine and thus a "biological product" subject to FDA regulation under the PHSA. 42 U.S.C. § 262(i).

Dendreon has been studying Provenge's safety and effectiveness in clinical trials pursuant to an investigational new drug application it submitted to the FDA in 1996. See Transcript of March 29, 2007 Cellular, Tissue, and Gene Therapies Advisory Committee Meeting at 20; (Doc. # 23, Ex. C.) Dendreon submitted its BLA for Provenge in late 2006, and the FDA considered it to be filed in January 2007. (Doc. # 22 ¶ 27.) Because Provenge is an immunotherapy vaccine, regulatory responsibility for reviewing and, ultimately, approving or denying approval of the BLA rests with the Office of Cellular, Tissue, and Gene Therapies in the FDA Center for Biologics Research and Evaluation ("CBER"). Id. ¶ 29; 68 Fed.Reg. 38067, 38068 (June 26, 2003).

In the Amended Complaint, Plaintiff claims that Pazdur intentionally violated "Federal Regulations and U.S. Law by improperly controlling the makeup of the FDA [Office of Cellular, Tissue, and Gene Therapies] Advisory Committee, and applying improper pressure on Committee members" in an effort to deny due process for the BLA for Provenge; purposely placed on the Advisory Committee two oncologists who had conflicts of interest and who Pazdur was sure would be opposed to the approval of Provenge; prior to the vote, changed the question posed to the. Advisory Committee members to get them to recommend against approval of Provenge; and "recruited and illegally used [the] FDA employees" at and after the Advisory Committee meeting to assist Pazdur in "wrecking" the Provenge BLA by requesting anti-Provenge letters and "design[ing] a method for `leaking' them to the press." (Doc. # 22 ¶¶ 6, 50, 62, 63, 67, 70, 71, 72, 73, 77, 79.)

Further, Plaintiff alleges that Scher "fail[ed] to disclose conflicts of interest that would have placed the FDA on notice that his own personal interests provided him additional reasons" to be opposed to the immediate approval of the Provenge, BLA; wrote a letter attacking Provenge that contained false information and that was later "leaked to the press"; and failed to exercise care in the responsibility he undertook to aid patients. Id. ¶¶ 7, 60, 70, 72, 77, 79.

Plaintiff also alleges Leavitt, who controls that agency with FDA oversight duties, "ignored and continues to ignore the agency's dysfunction." Id. ¶ 5. Finally, Plaintiff claims that von Eschenbach "decided not to approve Provenge for immediate use and instead issued a Complete Response Letter requesting more data which might not be available until 2010." Id. ¶ 43.

On May 8, 2007, CBER issued a Complete Response Letter to Dendreon, Provenge's sponsor, declining to approve the BLA in its current form because of various deficiencies. See Dendreon Corp., "Dendreon Receives Complete Response Letter from FDA for Provenge Biologics License Application," May 9, 2007, available at http://investor.dendreon.com/Release Detail.cfm?ReleaseID=241649 & Header =News ("Dendreon Receives Complete Response Letter"). The FDA requested that Dendreon submit additional information with respect to the chemistry, manufacturing, and controls section of the BLA, id.; such information is required to demonstrate that the facility in which the product would be manufactured "meets standards designed to assure that the biological product continues to be safe, pure, and potent." 42 U.S.C. § 262(a)(2)(C)(i)(II). The FDA also requested that Dendreon submit additional clinical data in support of its effectiveness claim. Dendreon Receives Complete Response Letter. Dendreon has since met with the FDA to discuss the additional data required to support licensure and indicated that it intends to proceed with its new Phase 3 study designed to measure survival and to submit such data to the FDA when it becomes available. See Dendreon Corp., "Dendreon, Announces FDA Confirms Data Required for Provenge Licensure," May 31, 2007, available at http: //investor.dendreon.com/ReleaseDetail.cfm?ReleaseID=246500 & Header=News.

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