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October 27, 2004.

JOHN DOE #1, et al, Plaintiffs,
DONALD H. RUMSFELD, et al Defendants.

The opinion of the court was delivered by: EMMET SULLIVAN, District Judge


I. Introduction

Six plaintiffs, known as John and Jane Doe #1 through #6, bring this action to challenge the lawfulness of the government's Anthrax Vaccination Immunization Program ("AVIP"). Specifically, plaintiffs, who are members of the active duty or National Guardsmen components of the Armed Forces and civilian contract employees of the Department of Defense ("DoD") who have submitted or have been instructed to submit to anthrax vaccinations without their consent pursuant to AVIP, have filed a Motion for Summary Judgment challenging the Food & Drug Administration's ("FDA") determination that anthrax vaccine adsorbed ("AVA") is licensed for the purposes of combating inhalation anthrax (also known as aerosolized or weaponized anthrax). Defendants, the Secretary of Defense (Donald Rumsfeld), the Secretary of Health and Human Services (Tommy Thompson), and the Commissioner of the Food and Drug Administration (Mark McClellan) have filed a Cross Motion for Summary Judgment asking this Court to declare that FDA's Final Rule and Order determining that AVA is licensed for anthrax regardless of the route of exposure is not arbitrary and capricious.

  In 1997, the Department of Defense ("DoD") instituted AVIP and began inoculating service members with AVA to prevent the harmful effects caused by exposure to anthrax.*fn1 Compl. ¶ 33. Anthrax is an acute bacterial disease caused by infection with spores of Bacillus anthracis, which can enter the body in three ways: by skin contact (cutaneous), by ingestion (gastrointestinal), and by breathing (inhalation). See 50 Fed. Reg. at 51,058.

  The AVIP is a multi-service vaccination program for active duty, Reserve and National Guard service members. Compl. ¶ 33. Under AVIP, military personnel are ordered to submit to a series of AVA inoculations over the course of eighteen months, followed by an annual booster vaccine. Compl. ¶ 47. If military personnel refuse to submit to the AVA inoculations, plaintiffs claim that they will be subject to military disciplinary actions, including court-martial convictions, forfeitures of pay, incarceration and other sanctions. Compl. ¶ 35. Civilian plaintiffs who refuse to comply with AVIP are subject to dismissal as DoD employees or defense contractors. Id.

  II. Statutory & Regulatory Framework

  A. The Public Health Service Act & The Food, Drug, and Cosmetic Act

  The Public Health Service Act ("PHSA"), 42 U.S.C. §§ 201 et seq., and the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301, et seq., govern the regulation of biological products in the United States. The FDCA charges FDA with approving drugs, including vaccines, that are safe, effective, and not misbranded. 21 U.S.C. § 355(d). The PHSA grants FDA authority to issue licenses for products that are "safe, pure, and potent." 42 U.S.C. § 262(a)(2)(C)(i)(I).

  Prior to 1972, the National Institute of Health ("NIH") was charged with implementing the PHSA's licensing requirement. In 1972, this authority was transferred to FDA. See Statement of Organization, Functions, and Delegations of Authority, 37 Fed. Reg. 12,865 (June 19, 1972). Upon the transfer of responsibility, FDA promulgated regulations establishing procedures for reviewing the safety, effectiveness, and labeling of all biological products previously licensed by the NIH. See Procedures for Review of Safety, Effectiveness and Labeling, 37 Fed. Reg. at 16,679. These regulations are codified in 21 C.F.R. § 601.25.

  B. 21 C.F.R. § 601.25

  21 C.F.R. § 601.25 established a two-stage process for reviewing biological products licensed prior to July 1, 1972. It directs FDA's Commissioner ("Commissioner") to appoint an advisory panel (1) to evaluate the safety and effectiveness of the previously licensed product, (2) to review the labeling of the product, and (3) to advise the Commissioner "on which of the biological products under review are safe, effective, and not misbranded." See 21 C.F.R. § 601.25(a).

  Each panel must submit a report. See § 601.25(e). The report must contain a "statement . . . designat[ing] those biological products determined by the panel to be safe and effective and not misbranded" and this statement "may include any conditions relating to active components, labeling, tests required prior to release of lots, product standard, or other conditions necessary or appropriate for their safety and effectiveness." § 601.25(e)(1).

  After reviewing the recommendation, the Commissioner must publish the panel report and a proposed order. See 21 C.F.R. § 601.25(f). After reviewing comments on the proposed order, the Commissioner "shall publish . . . a final order on the matters covered" therein, which shall "constitute final agency action from which appeal lies to the courts." See §§ 601.25(g), 601.25(i).

  C. Expert Panel Review

  In 1973, FDA announced the Section 601.25 safety and effectiveness review of several "bacterial vaccine[s]" previously licensed under PHSA, including AVA, and solicited relevant data and information from manufacturers in order to determine whether the drugs were "safe, effective, and not misbranded." See Safety, Effectiveness and Labeling Review; Request for Data Information, 38 Fed. Reg. 5,358 (Feb. 28, 1973).

  A scientific Advisory Panel was convened, and in 1980, after considering the relevant data and information, the Panel submitted its report. See A.R. 1-600. The Panel observed that AVA "appears to offer significant protection against cutaneous anthrax." The Panel noted that "there is sufficient evidence to conclude that anthrax vaccine is safe and effective under the limited circumstances for which [it] is employed." See A.R. at 338, 342. Therefore, the Report recommended that AVA "be placed in Category I" (safe, effective, and not misbranded) and that the appropriate licenses be continued because there is substantial evidence of safety and effectiveness for this product." Id. at 342. In the Panel's review of "recommended use," it found that "this product is intended solely for immunization of high-risk of exposure industrial populations such as individuals who contact imported animal hides, furs, bone meal, wool, hair (especially goathair) and bristles" along with "laboratory investigators handling the organism." Id. at 340.

  In arriving at this decision, the Panel considered two sets of data: (1) a human field trial conducted by Drs. Brachman, Glod, Plotkin, Fekety, Werrin, and Ingraham in the 1950's ("Brachman study"), A.R. 3732-45, and (2) surveillance data collected and summarized by the Center for Disease Control ("CDC"). See A.R. at 337-38.

  The Brachman study involved 1,249 workers in four textile mills that processed imported goat hair. See A.R. 3732-33. A portion of the workers received the anthrax vaccine, a portion received a placebo vaccine, and a portion received no treatment. See A.R. 3737 (Table 2), A.R. 3736 (Table 4); 50 Fed. Reg. at 51,058 (Panel). During the evaluation period, which included an "outbreak" of inhalation anthrax, twenty-six cases of anthrax occurred. See A.R. 3733. The results can best be summarized as follows:
Total Cases (26) Anthrax Vaccine Placebo No vaccine
Inhalation 5 0 2 3
Cutaneous 21 3 (2 incomplete 15 (2 incomplete vaccine) vaccine) 3
  A.R. 3733-36. The Brachman study calculated the effectiveness of the anthrax vaccine at 92.5 percent. See A.R. 3737. The authors of the study based their calculations on a comparison between the placebo and the anthrax vaccine group regardless of the route of exposure.

  While relying on the Brachman study for its recommendation of effectiveness, the Panel stated that the study demonstrates "93 percent . . . protection" against only cutaneous anthrax and that "[i]nhalation anthrax occurred too infrequently to assess the protective effect of vaccine against this form of the disease." 50 Fed. Reg. at 51,058 (Panel).

  The Panel also considered surveillance data collected by the CDC "on the occurrence of anthrax in at-risk industrial settings." 50 Fed. Reg. at 51,058 (Panel). While twenty-seven cases were observed, no cases occurred in persons who were fully vaccinated. Id.

  D. FDA's Proposed Rule and Order

  In 1985, citing Section 601.25's procedural requirements, FDA published notice of a Proposed Rule to reclassify bacterial vaccines and toxoids covered by the Panel Report. See Bio. Prods; Bacterial Vaccines & Toxoids; Implementation of Efficacy Review; Proposed Rule, 50 Fed. Reg. 51,002 (Dec. 13, 1985) ("Proposed Rule").*fn2 The Proposed Rule adopted the Panel Report verbatim with respect to AVA, including the Panel's recommendation to classify AVA as Category I and the Panel's note that "[i]mmunization with this vaccine is indicated only for certain occupational groups with risk of uncontrollable or unavoidable exposure to the organism." See 50 Fed. Reg. at 51,058. The Proposed Rule found that "the benefit-to-risk assessment is satisfactory" for this "limited high-risk population." 50 Fed. Reg. at 51,059.

  The Proposed Rule required comments "on the proposed classification of products into Category I . . . be submitted by March 13, 1986." 50 Fed. Reg. at 51,002. Four total comments were received, none of them specifically addressing the proposal to reclassify AVA. See 69 Fed. Reg. 255, 256-259 ("Final Rule and Order"). FDA took no further action until December 30, 2003 — eighteen years after the Proposed Rule, but only eight days after this Court's Order enjoining DoD's AVIP.

  E. The Law Regarding Unapproved Drugs and Military Personnel

  In 1998, in response to concerns about the use of investigational new drugs during the 1991 Gulf War that may have led to unexplained illnesses among veterans, Congress enacted 10 U.S.C. § 1107. This provision prohibits the administration of investigational new drugs, or drugs unapproved for their intended use, to service members without their informed consent. The consent requirement may be waived only by the President. In 1999, the President signed Executive Order 13,139, pursuant to which DoD must obtain informed consent from each individual member of the armed forces before administering investigational drugs and under which waivers of informed consent are granted only "when absolutely necessary." Exec. Order No. 13,139, 64 Fed. Reg. 54,175 (Sept. 30, 1999). In August 2000, DoD formally adopted these requirements in DoD Directive 6200.2.

  F. Citizen Petition

  On October 12, 2001, a group of individuals filed a citizen petition requesting that FDA declare that AVA is ineffective for use against inhalation anthrax and issue a final order classifying AVA as a Category II product. See A.R. 1313-75. The petitioners argued that the Panel had erred in concluding that the Brachman study qualified as a well-controlled field trial for purposes of 21 C.F.R. § 601.25(d)(2). See A.R. 1316-17 & n. 6. In its August 28, 2002 response, FDA explained that it was "working to complete this rulemaking as soon as possible," and that given "the pendency of this rulemaking," it could not "evaluate the adequacy of the Panel recommendation."*fn3 A.R. 1378. G. The Preliminary Injunction

  In March 2003, plaintiffs filed suit in this Court, alleging that the AVIP violates federal law because AVA had never been approved as a safe and effective drug for protection against inhalation anthrax. Plaintiffs asked this Court to enjoin DoD from inoculating them without their informed consent.

  On December 22, 2003, this Court issued a Preliminary Injunction enjoining inoculations under the AVIP in the absence of informed consent or a Presidential waiver. Because the record was devoid of an FDA final decision on the investigational status of AVA, the Court was persuaded that AVA was an investigational drug being used for an unapproved purpose in violation of 10 U.S.C. § 1107, ...

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