United States District Court for the District of Columbia
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
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
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
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." §
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),
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.
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
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
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
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, Executive Order 13,139, and DoD Directive 6200.2.
See Doe v. Rumsfeld, 297 F. Supp. 2d 119, 135 (D.D.C. 2003).
H. Final Rule and Order
Eight days after this Court's Preliminary Injunction and
eighteen years after FDA proposed to reclassify AVA, the agency
announced a Final Rule and Order classifying AVA as a Category I
drug. See Bio. Prods; Bacterial Vaccines & Toxoids;
Implementation of Efficacy Review; 69 Fed. Reg. 255, 265-66 (Jan.
5, 2004) ("Final Rule and Order"). The Final Rule and Order
stated that AVA was safe and effective "independent of the route
of exposure." See id. at 257-59. At the same time, FDA issued a press release noting that a
recent ruling by a United States District Court for
the District of Columbia gave the opinion that the
anthrax vaccine should be classified as
`investigational' with regard to protecting against
inhalation anthrax. Today's final rule and order make
clear that FDA does not regard the approved anthrax
vaccine as `investigational' for protection against
inhalation anthrax. FDA's final determination of the
safety and effectiveness of the anthrax vaccine,
independent of route of exposure, as well as its
conclusions regarding the Expert Panel's report,
being announced today in the final order are relevant
and should be considered in any further litigation in
The Final Rule and Order relied on several sources of data to
support its finding of safety and efficacy, including the
Brachman Study, the CDC surveillance data, the results of a
"small randomized clinical study of the safety and immunogenicity
of AVA" conducted by the DoD, "post licensure adverse event
surveillance data available from the Vaccine Adverse Event
Reporting System (VAERS)," and an independent examination by the
Institute of Medicine ("IOM"). See Final Rule and Order at 260.
In its discussion, FDA explained, for the first time, certain
"points of disagreement with statements in the Panel Report."
See id. at 259. Specifically, FDA disagreed with the Expert
Panel's interpretation of the Brachman Study. FDA concluded:
because the Brachman comparison of anthrax cases
between the placebo and vaccine groups included both
inhalation and cutaneous cases, FDA has determined
that the calculated efficacy of the vaccine to
prevent all types of anthrax disease combined was, in fact, 92.5
percent. . . . The efficacy analysis in the Brachman
study includes all cases of anthrax disease
regardless of the route of exposure or manifestation
Id. at 259-60.
FDA did note that the five cases of inhalation anthrax were
"too few to support an independent statistical analysis." Id.
at 260. However, FDA explained that:
of these [five] cases, two occurred in the placebo
group, three ocurred in the observation group, and no
cases occurred in the vaccine group. Therefore, the
indication section of the labeling for AVA does not
specify the route of exposure, and the vaccine is
indicated for active immunization against Bacillus
anthracis [anthrax], independent of the route of
Moreover, FDA noted that the surveillance data was "supportive
of the effectiveness of AVA." Id. at 260. FDA also discussed
the independent examination by IOM of AVA's safety and
effectiveness, during which the IOM Committee "reviewed all
available data, both published and unpublished, [and] heard from
Federal agencies, the manufacturer and researchers." Id. Noting
that the abstract of the IOM's Report stated "that AVA, as
licensed, is an effective vaccine to protect humans against
anthrax including inhalation anthrax," FDA stated it
agrees with the report's finding that studies in
human and animal models support the conclusion that
AVA is effective against B. Anthracis strains that
are dependant upon the anthrax toxin as mechanism or
virulence, regardless of the route of exposure.
Id. at 260 & n. 5. I. The Present Case
Following the announcement of FDA's Final Rule and Order, the
Court granted defendants' request to stay the Court's earlier
Preliminary Injunction except as it applied to the six Doe
plaintiffs.*fn4 See Order dated January 7, 2004, at 1-2.
Plaintiffs now ask this Court to vacate FDA's recent Final Rule
and Order and to remand the matter to FDA for proper
consideration and a determination of the licensing status of AVA.
In addition, plaintiffs request that the Court reinstate the
injunctive relief, albeit now on a permanent basis, that was
granted in its initial ruling of December 22, 2003, because
absent a valid final rule and/or order, the Court's conclusion
that the vaccine is improperly licensed for inhalation anthrax
remains in effect. Alternatively, plaintiffs ask that summary
judgment not be granted to defendants and ask that they be
permitted to conduct discovery in order to ensure that the
administrative record is complete and was not improperly
influenced by DoD. Defendants ask this Court to grant summary
judgment in their favor. III. Standard of Review
Pending before this Court are cross motions for summary
judgment. Summary judgment is granted pursuant to Federal Rule of
Civil Procedure 56 only when there are no genuine issues of
material fact and the moving party is entitled to judgment as a
matter of law. See Celotex Corp. v. Catrett, 477 U.S. 317, 322
(1986). The Court views the evidence in the light most favorable
to the nonmoving party, according the party the benefit of all
reasonable inferences. See Anderson v. Liberty Lobby, Inc.,
477 U.S. 242, 255 (1986). Thus, in ruling on cross motions for
summary judgment, the Court will grant summary judgment only if
one of the moving parties is entitled to judgment as a matter of
law upon material facts that are not in dispute. See Rhoads v.
McFerran, 517 F.2d 66, 67 (2d Cir. 1975).
There are no genuine material facts that preclude judgment in
this matter. If the FDA's Final Rule and Order categorizing AVA
as safe and effective for protection against inhalation anthrax
was issued in accordance with the relevant law, then DoD's AVIP
is lawful; conversely, if FDA's Final Rule and Order is invalid,
the AVIP is unlawful absent informed consent or a Presidential
Under the Administrative Procedure Act, a reviewing court may
hold unlawful and set aside final agency action found to be
"arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law," or "without observance of procedure
required by law." 5 U.S.C. § 706(2).
This Court is mindful that the standard of review for agency
action is highly deferential. See American Public Communications
Council v. FCC, 215 F.3d 51, 61 (D.C. Cir. 2000); Bristol-Myers
Squibb Co. v. Shalala, 923 F. Supp. 212, 216 (D.D.C. 1996).
Ordinary deference may be heightened even further in cases
involving scientific or technical decisions. See Serono Labs.,
Inc., v. Shalala, 158 F.3d 1313, 1320 (D.C. Cir. 1998) (noting
that an agency is entitled to a "high level of deference" when
its regulatory determination rests on its "evaluation  of
scientific data within its area of expertise"). The
"determination whether a drug is generally recognized as safe and
effective within the meaning of [the FDCA] necessarily implicates
complex chemical and pharmacological considerations." Weinberger
v. Bentex Pharms, Inc., 412 U.S. 645, 654 (1973). FDA's
"judgment as to what is required to ascertain the safety and
efficacy of drugs" thus falls "`squarely within the ambit of
FDA's expertise and merit[s] deference from' the courts."
Bristol-Myers, 923 F. Supp. at 220 (quoting Schering Corp. v.
FDA, 51 F.3d 390, 399 (3d Cir.), cert denied, 516 U.S. 907
Although FDA's scientific expertise is due great deference, it
is well within this Court's scope of authority to ensure that the agency adheres to its own procedural requirements. See
Service v. Dulles, 354 U.S. 363 (1957) (seminal case standing
for the proposition that judicial review is available to ensure
that agencies comply with their own voluntarily-promulgated
regulations, even where Congress has given the agency "absolute
discretion" over the administrative action in question). See
also Rodway v. United States Dept. of Agric., 514 F.2d 809,
813-14 (D.C. Cir. 1975) (requiring the agency to comply with its
own regulations "making the procedural requirements of [the APA]
applicable" because "it is, of course, well settled that validly
issued administrative regulations have the force and effect of
law") (citing Morton v. Ruiz, 415 U.S. 199, 235 (1974);
Vitarelli v. Seaton, 359 U.S. 535, 539-540 (1959); Service,
354 U.S. at 388). In this case, the Court focuses not on FDA's
substantive and highly technical determinations regarding the
safety of AVA, but rather on whether or not the Agency observed
the relevant "procedure required by law."
The party asserting jurisdiction always has the burden to prove
standing. FW/PBS Inc. v. City of Dallas, 492 U.S. 21, 23
(1990). To have standing, a plaintiff must allege: (1) an "actual
or imminent" injury-in-fact; (2) "fairly . . . trace[able] to the challenged action of the defendant"; and (3)
"likely" to be "redressed by a favorable decision." Lujan v.
Defenders of Wildlife, 504 U.S. 555, 560-61 (1992). At the
summary judgment stage, "the plaintiff can no longer rest on . . .
`mere allegations'," but must "`set forth' by affidavit or
other evidence `specific facts'" establishing standing. Lujan,
504 U.S. at 561 (quoting Fed.R. Civ. P. 56(e)).
The Court has recognized that in order to establish injury
plaintiffs must demonstrate that they have taken, or have been
ordered imminently to take, the anthrax vaccine. See Doe,
297 F. Supp. 2d at 130-31. While defendants argue that plaintiffs
have presented no "specific facts" in support of these claims,
the Court accepts and credits the sworn affidavit of plaintiffs'
counsel. Thus, plaintiffs have standing to challenge the FDA's
B. The Status of FDA's December 30, 2003 Issuance
At the outset, the parties dispute whether the FDA's December
30, 2003 issuance, labeled a "Final Rule and Order," was in fact
a Final Rule or a Final Order.*fn5 The Court will address
this issue in the first instance.
The APA defines two broad, normally mutually exclusive categories of agency action rules and orders. See Bowen v.
Georgetown Univ. Hosp., 488 U.S. 204, 216 (1988) (Scalia, J.,
concurring) (distinction between rules and orders is "the entire
dichotomy upon which the most significant portions of the APA are
based"). The APA defines a "rule" as:
the whole or a part of an agency statement of general
or partial applicability and future effect designed
to implement, interpret, or prescribe law or policy
or describing the organization, procedure, or
practice requirements of an agency and includes the
approval or prescription for the future of rates,
wages, corporate or financial structures or
reorganization thereof, prices, facilities,
appliances, services, or allowance therefor or of
valuation, costs, or accounting, or practices bearing
on any of the foregoing.
5 U.S.C. § 551(4). "[R]ule making," which can be formal or
informal, is the "agency process for formulating, amending, or
repealing a rule." Id. at § 551(5).
When promulgating a substantive rule, an agency must comply
with the notice-and-comment requirements of 5 U.S.C. § 553. See
5 U.S.C. § 553(b). Notice and comment requires that an agency
provide notice of a proposed rulemaking, and that notice must
include "either the terms or substance of the proposed rule or a
description of the subjects and issues involved."
5 U.S.C. § 553(b). Once a proposed rule is issued, the agency must "give
interested persons an opportunity to participate in the
rulemaking through submissions of written data, views, or
arguments." 5 U.S.C. § 553(c).
The APA defines an "order" as: the whole or a part of a final disposition, whether
affirmative, negative, injunctive, or declaratory in
form, of an agency in a matter other then rule making
but including licensing.
Id. at § 551(6). "Adjudication," which can also be formal or
informal, is the "agency process for the formulation of an
order." Id. at § 551(7).
Plaintiffs claim that in conducting its review of AVA, FDA
acted in a manner consistent with the exercise of rulemaking and
that it was not until the present litigation that defendants
sought to recast the AVA certification process.*fn6
Plaintiffs allege that FDA's rulemaking denied affected parties
the opportunity to effectively participate in the process, and
that the Final Rule should be invalidated and remanded to the
Defendants argue that a decision by FDA to place a biological
product in Category I, thereby confirming its license, falls
squarely within the definition of an "order" for purposes of the
APA. See 5 U.S.C. § 551(6). Defendants note that Section 601.25
itself refers to FDA's determination as an "order." See
21 C.F.R. § 601.25(f). Defendants observe that FDA's process for
licensing biological products is not itself subject to rulemaking
requirements. See, e.g., 42 U.S.C. § 262(a)(2)(A) ("[t]he Secretary shall establish, by regulation, requirements for
approval, suspension, and revocation of biologics licenses");
21 C.F.R. §§ 601.2 601.9. Thus, defendants note that were AVA a
new biological product for which the manufacturer was seeking an
initial license, FDA would not be required by the APA's
rulemaking provision to publish its licensing decision for notice
Moreover, defendants allege that FDA's decision placing AVA in
Category I bears none of the hallmarks of a "rule." It does not
"implement, interpret, or prescribe law or policy."
5 U.S.C. § 551(4). Instead, defendants claim, the decision merely applies
already-existing legal standards to specific facts the hallmark
of adjudication. Defendants note that the decision has no "future
effect" (5 U.S.C. § 551(4)); it merely determines the "past and
present rights and liabilities" of AVA's manufacturer with
respect to an already-issued license. See Bowen,
488 U.S. at 219 (Scalia, J., concurring); see also Goodman v. FCC,
182 F.3d 987, 994 (D.C. Cir. 1999). Defendants submit that consistent with
Section 601.25(g), FDA referred to its licensing decision as a
"Final Order" in several places. See Final Rule and Order at
Plaintiffs claim that FDA has considered determinations like
the one issued regarding AVA as rulemaking subject to judicial
review. In Contact Lens Manufacturers Ass'n v. FDA, a
commercial association sued FDA over its decision to classify contact lenses
according to the product's safety and effectiveness.
766 F.2d 592, 594 (D.C. Cir. 1985). In describing the safety and
effectiveness of the lenses, FDA utilized a three class
categorization system. Contact lens manufacturers whose products
had been placed in Class III lobbied to reverse FDA's proposal to
stop a transfer of a category of lenses from Class III to Class
I. Plaintiffs claim that the determination made by FDA with
regard to the products' status are virtually identical to the
determination at issue here. Nevertheless, FDA provided extensive
comment periods, and even a public hearing. Id. at 596-7.
In Cutler v. Hayes, FDA engaged in a comprehensive review of
the safety and effectiveness of all over-the-counter drugs.
818 F.2d 879 (D.C. Cir. 1987). In doing so, FDA used a process,
again, virtually identical to the one at issue here. To start,
advisory review panels of experts were appointed to analyze
existing test data and make recommendations in the form of
monographs. Id. at 884. FDA reviewed the monographs, published
them in the Federal Register, opened the period for public
comment, and made a final recommendation, which was also open for
public comment. Id. FDA then promulgated a determination
classifying the drug as either Category I (safe and effective),
Category II (not generally recognized as safe and effective), or Category III (data is insufficient to classify as I or II). In
making its determination, FDA invited public comment twice.
Defendants acknowledge that FDA did provide interested parties
an opportunity to comment on its Proposed Order categorizing AVA
as a Category I product. Defendants argue that while agencies
have discretion to employ "extra procedural devices," the court
may not second guess the agency's decision not to do so. See
Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense
Council, Inc. 435 U.S. 519, 545 (1978).
The D.C. Circuit has explained that when determining whether
agency action is rulemaking or adjudicating:
the focus is not on whether the particular proceeding
involved trial-type devices but instead turns on the
nature of the decision to be reached in the
proceeding. Rulemaking is prospective in scope and
nonaccusatory in form, directed to the implementation
of general policy concerns into legal standards.
Adjudication, on the other hand, is "individual in
impact and condemnatory in purpose," directed to the
determination of the legal status of a particular
person or practices through the application of
preexisting legal standards.
FTC v. Brigadier Industries Corp., 613 F.2d 1110, 1117 (D.C.
It appears to the Court that the agency held AVA up to a
pre-determined standard and made a judgment as to whether to
classify AVA as safe and effective or otherwise. This suggests to
this Court that FDA has issued an order. However, Section
601.25(g) and (i) instruct the agency to take comments for 90
days. While orders typically fall outside the confines of APA rulemaking, see 5 U.S.C. § 553, here, the Court is confronted
with a situation where the agency decided that notice and comment
regarding the proposed order was the correct course of action.
This procedure is not without precedent.*fn7
In Contact Lens Manufacturers, the FDA reviewed products for
safety and efficacy, provided opportunity for public input
through the notice-and-comment process and public hearings, and
published an Order as is evidenced by the D.C. Circuit's labeling
of its review as a "Petition for Review of an Order of the Food
and Drug Administration." 766 F.2d at 593 (emphasis added).
Cutler also provided an opportunity for the public to submit
comments following the publication of a proposed order. See
818 F.2d at 884. Thus, the Court is persuaded that the December 30,
2003 issuance was an order. While orders do not ordinarily
require notice and comment, the plain meaning of Section 601.25
of FDA's regulations requires notice and comment on the
classification of the biologics in question: (4) The full report or reports of the panel to the
Commissioner of Food and Drug. The summary minutes of
the panel meeting or meetings shall be made available
to interested persons upon request. Any interested
person may within 90 days after publication of the
proposed order in the Federal Register, file with the
Hearing Clerk of the Food and Drug Administration
written comments in quintuplicate. . . .
(g) Final order. After reviewing the comments, the
Commissioner of Food and Drugs shall publish in the
Federal Register a final order on the matters covered
in the proposed order.
21 C.F.R. § 601.25(f)(4) & (g). This requirement is also
reflected in FDA's Final Rule and Order:
In accordance with § 601.25, after reviewing the
conclusions and recommendations of the review panel,
FDA would publish in the Federal Register a proposed
order . . . After reviewing public comments, FDA
would publish a final order on the matters covered in
the proposed order.
69 Fed. Reg. 255.
Notice and comment gives interested parties an opportunity to
participate through the submission of data, views and
arguments.*fn8 See Vermont Yankee Nuclear Power Corp. v.
Natural Resources Defense Council, Inc., 435 U.S. 519 (1978).
Notice and comment also ensures fairness to all parties and
provides a well-developed record something this case is
severely lacking. See Sprint Corp v. FCC, 315 F.3d 369 (D.C.
Cir. 2003); see also Tr. 5/25/04 at 2 (by the Court "Let me
just say at the outset that the administrative record in this case is one of the most
confusing, jumbled records this Court has ever seen. Indeed, the
only thing that is clear is that confusion abounds.").
Although defendants are correct that the courts may not compel
an agency to employ "extra procedural devices," this Court shall
compel an agency to follow the procedures set forth in its own
regulations. In this case, FDA's regulations require it to: (1)
publish a proposed order in the Federal Register after
considering the expert panel's recommendations; (2) provide 90
days for interested persons to file written comments on the
proposal; and (3) publish a final order on the matters covered in
the proposed order. See 21 C.F.R. § 601.25 (f)(4) & (g). Thus,
this Court will concentrate its review on the sufficiency of
FDA's compliance with these procedures. To guide its analysis,
the Court will look to the substantial body of existing case law
that gives meaning to what is meant by "notice and comment" under
C. Procedural Challenges to FDA's Final Rule and Order
1. Studies Outside the Comment Period
The public was invited to submit comments on the Proposed Order
for 90 days, from December 13, 1985, until the period closed on
March 13, 1986. However, eighteen years later when the Final Rule
and Order was published, FDA relied on studies and data that were not in existence at the conclusion of the
comment period. Plaintiffs argue that the D.C. Circuit has
frowned on this practice, noting that "[a]n agency commits
serious procedural error when it fails to reveal portions of the
technical basis for a proposed rule in time to allow for
meaningful commentary." Conn. Light & Power Co. v. Nuclear
Regulatory Comm'n, 673 F.2d 525, 530-31 (D.C. Cir. 1982). It is
clear that when an agency relies on studies or data after the
comment period has ended, no meaningful commentary on such data
is possible. See American Iron & Steel Inst. v. OSHA,
939 F.2d 975, 1009-10 (D.C. Cir. 1991); Small Refiner Lead Phase-Down
Task Force v. EPA, 705 F.2d 506, 540-41 (D.C. Cir. 1983);
Sierra Club v. Costle, 657 F.2d 298, 398 (D.C. Cir. 1981).
In American Iron & Steel, OSHA relied on a professional
industry analysis that was completed after the comment period had
ended in evaluating the economic feasibility of certain workplace
exposure levels. The D.C. Circuit held that "reliance on the
[post-comment period data] without providing an opportunity for
comment was improper," and the court vacated the portion of the
regulation that relied on the late data. See 939 F.2d at 1010.
Here, plaintiffs argue that FDA relied on at least four
extensive studies that commenced and concluded after the comment
period ended. See 69 Fed. Reg. at 265-66. For example, FDA cites and relies on a report on the anthrax vaccine issued by the
Institute of Medicine ("IOM") in 2002 sixteen years after the
comment period ended. Id. at 259-60. In issuing its report, the
IOM evaluated "all available data, both published and
unpublished" on the anthrax vaccine, specifically focusing on
three studies from 1996, 1998, and 2001. Id. at 260 & n. 5.
Moreover, plaintiffs note that of the 4,209 pages in the
administrative record, approximately 2,653 (63%) post-date 1986.
Plaintiffs allege that persons who submitted comments in late
1985 and early 1986 were deprived of the opportunity to comment
on these studies. Plaintiffs argue that this procedural flaw is
so fundamental as to require the invalidation of FDA's Final Rule
2. Deviations From The Proposed Rule
While "a final rule need not be identical to the original
proposed rule," when the final rule "deviates too sharply from
the proposal, affected parties will be deprived of notice and an
opportunity to respond to the proposal." AFL-CIO v. Donavan,
757 F.2d 330, 338 (D.C. Cir. 1985). The test is whether the final
rule is a "logical outgrowth" of the proposed rule. If "a new
round of notice and comment would provide the first opportunity
for interested parties to offer comments that could persuade the
agency to modify its rule," then the final rule is not a "logical outgrowth." American Water Works Assoc. v. EPA,
40 F.3d 1266, 1274 (D.C. Cir. 1994). See also Nat'l Mining
Assoc. v. Mine Safety & Health Admin., 116 F.3d 520, 531 (D.C.
In Shell Oil Co. v. EPA, plaintiffs asserted that the EPA's
Final Rule contained a definition of "hazardous waste" that was
much broader than the definition contained in the proposed rule
and, as a result, they claimed not to have notice of the
definition that was finally adopted. 950 F.2d 741, 748 (D.C. Cir.
1991). EPA argued that it intended to include the broader aspects
of the definition, and that interested parties should have
anticipated the substance of the final rule. Id. at 749-50. In
setting aside the rule and remanding it to the EPA, the D.C.
Circuit held that an agency's "unexpressed intention cannot
convert a final rule into a `logical outgrowth' that the public
should have anticipated. Interested parties cannot be expected to
divine the EPA's unspoken thoughts." Id. at 751-52.
Defendants argue that FDA's Final Rule and Order is identical
to what it proposed in 1985 to place AVA in Category I.
Compare Biological Products; Bacterial Vaccines and Toxoids;
Implementation of Efficacy Review, 50 Fed. Reg. 51,002, 51,104
(Dec. 13, 1985) with Final Rule and Order at 259. They claim
that plaintiffs' position is based on a misunderstanding of the
Expert Panel's recommendation. Defendants state that when the Panel issued its report, AVA was indicated for persons at risk to
exposure to the anthrax bacterium and its label did not specify a
route of exposure. See 50 Fed. Reg. at 51,059.
Moreover, defendants contend that the Panel recommended
Category I notwithstanding the Panel's alleged erroneous belief
that the Brachman study did not assess the protective effect of
the vaccine against inhalation anthrax. Defendants claim that
this "framed . . . for discussion" whether AVA should be placed
in Category I for use against inhalation anthrax. See Omnipoint
Corp. v. FCC, 78 F.3d 620, 631 (D.C. Cir. 1996). Thus,
defendants argue that FDA provided adequate "opportunities for
interested parties to offer comments that could persuade the
agency to modify its rule." See American Water Works,
40 F.3d at 1274.
However, the Court finds that the public has never been
afforded an opportunity to comment on the safety and efficacy of
AVA as it pertains to inhalation anthrax. FDA's Proposed Order
(though called a "Proposed Rule" when published) only contained
the Panel's assessment of AVA. It found that the anthrax vaccine
was safe and effective in "the limited circumstances for which
this vaccine is employed." 50 Fed. Reg. at 51,059. At that time,
the vaccine was employed for use by "certain occupational
groups," mainly "individuals in industrial settings" who worked
with animal furs, hides and hairs. 50 Fed. Reg. at 51,058. The vaccine's use was intended to be for
"protection against cutaneous anthrax in fully immunized
subjects." 50 Fed. Reg. at 51,059. The Panel concluded that, "no
meaningful assessment of the [the vaccine's] value against
inhalation anthrax is possible." Id. It was under this premise
that the public was on notice to submit comments.
Interested parties in 1985 could not have anticipated that FDA
would permit the vaccine to be used for inhalation anthrax as a
result of exposure through a biological attack.*fn9 In 1985
there would have been no reason to submit comments on the
vaccine's use against other routes of exposure for the population
at large; indeed, not a single comment was received on anthrax in
response to the Proposed Rule.
Now, for the first time, eighteen years later, FDA's Final Rule and Order asserts that FDA "does not agree with the Panel
report," and believes that "the vaccine is indicated for active
immunization against [anthrax], independent of the route of
exposure," and that the vaccine will "protect humans against . . .
inhalation anthrax." 69 Fed. Reg. at 259-60.
The Court finds that this significant post-comment expansion of
the scope of FDA's inquiry deprived the public of a meaningful
opportunity to submit comments and participate in the
administrative process mandated by law. Because "a new round of
notice and comment would provide the first opportunity for
interested parties to offer comments that could persuade" the FDA
to change its position with regard to the use of AVA against
inhalation anthrax, the Agency's Final Rule and Order is by no
means a "logical outgrowth" of the 1985 Proposed Rule. See
American Water Works, 40 F.3d at 1274. This failure to provide
for a meaningful opportunity to comment, as required by FDA's own
regulations, violates the APA. See 5 U.S.C. § 706(2).
While vacatur is the normal remedy for an APA violation, a
plaintiff must "show prejudice from an agency's procedural
violation." City of Waukesha v. EPA, 320 F.3d 228, 246 (D.C.
Cir. 2003). For a plaintiff to establish prejudice on the basis
of a "logical outgrowth" argument, a plaintiff generally must
show (1) that, "had proper notice been provided, they would have
submitted additional, different comments that could have invalidated the rationale for the revised rule;" or (2) that "the
agency has entirely failed to comply with the notice-and-comment
requirements, and the agency has offered no persuasive evidence
that possible objections to its final rules have been given
sufficient consideration." Id.
Defendants argue that plaintiffs cannot make the first showing
because FDA did consider and reject arguments against the
rationale for its effectiveness determination in the course of
responding to the citizen petition. See, e.g., A.R. 1376-85. In
its Final Rule and Order, FDA expressly referred to the citizen
petition and its response. See FDA Rule and Order at 259 n. 2.
Further, defendants claim that FDA's citizen petition response
provides "persuasive evidence" that it considered fully "possible
objections" to the Order. See City of Waukesha,
320 F.3d at 246.
However, the Court is not persuaded. While some individuals may
have submitted comments as part of a citizen petition, it is
clear to this Court that if the status of the anthrax vaccine
were open for public comment today, the agency would receive a
deluge of comments and analysis that might inform an open-minded
agency. Airborne exposure to anthrax was not an indication under
the licensing contemplated by the 1985 Proposed Rule and a new
notice-and-comment period would be the first opportunity that
interested parties would have to challenge the vaccine's efficacy against such exposure.
Thus, the Final Rule and Order shall be vacated and remanded to
the agency for reconsideration following an appropriate
notice-and-comment period in accordance with the APA, the
Agency's own regulations, and this Memorandum Opinion and
V. Scope of Injunction
Having vacated and remanded FDA's Final Rule and Order, the
posture of this case reverts back to where it was on December 22,
2003, when this Court granted plaintiffs' Motion for a
Preliminary Injunction. Thus, for all the reasons stated in this
Court's December 22, 2003 opinion, including Congress's
prohibition on forced inoculations with "investigational" drugs,
see 10 U.S.C. § 1107, the Court shall now issue a permanent
injunction. Unless and until FDA follows the correct procedures
to certify AVA as a safe and effective drug for its intended use,
defendant DoD may no longer subject military personnel to
involuntary anthrax vaccinations absent informed consent or a
Presidential waiver. In the days after the Court issued its injunction, there was
much discussion concerning whether the injunction applied to the
six Doe plaintiffs or whether the injunction applied to all
persons affected by the DoD's involuntary anthrax program.
Because it is inevitable that this concern will be raised again,
the Court shall address it now.*fn11
Traditionally, "[l]itigation is conducted by and on behalf of
the individual named parties only." Califano v. Yamasaki,
442 U.S. 682, 700-01 (1979). This general rule is based on the
fundamental principles of due process and prudential standing.
See, e.g., Allen v. Wright, 468 U.S. 737, 751 (1984) (noting
"the general prohibition on a litigant's raising another person's
legal rights"); Singleton v. Wulff, 428 U.S. 106, 113-14 (1976)
("[C]ourts should not adjudicate [the] rights [of third persons]
unnecessarily, and it may be that in fact the holders of those
rights either do not wish to assert them, or will be able to
enjoy them regardless of whether the in-court litigant is
successful or not.").
However, the Court notes that this litigation concerns the
lawful status of the anthrax vaccine. Having found that the
vaccine's use without informed consent or a Presidential waiver is unlawful, this Court would be remiss to find that a conflict
exists between service members who think that the DoD should be
required to follow the law and those service members who think
The Fourth, Fifth, Ninth, and D.C. Circuits have held that an
injunction can benefit parties other than the parties to the
litigation. See, e.g., National Mining Ass'n, et. al., v. U.S.
Army Corps of Engineers, et. al., 145 F.3d 1399 (D.C. Cir. 1998)
; Bresgal v. Brock, 843 F.2d 1163 (9th Cir. 1987); Evans v.
Harnett County Bd. of Educ., 684 F.2d 304 (4th Cir. 1982);
Meyer v. Brown & Root Construction Co., 661 F.2d 369 (5th Cir.
1981). The Supreme Court has implicitly agreed with this
proposition. Lujan v. National Wildlife Federation,
497 U.S. 871, 913 (1990).
"There is no general requirement that an injunction affect only
the parties in the suit. Where, as here, an injunction is
warranted by a finding of defendants' outrageous unlawful
practices, the injunction is not prohibited merely because it
confers benefits upon individuals who were not named plaintiffs
or members of a formally certified class." McCargo v. Vaughn,
778 F. Supp. 1341, 1342 (E.D. Pa. 1991). A district court has
"broad power to restrain acts which are of the same type or class
as unlawful acts which the court has found to have been committed
or whose commission in the future, unless enjoined, may fairly be anticipated from the defendant's conduct in the
past." N.L.R.B. v. Express Publ'g Co., 312 U.S. 426, 435
The D.C. Circuit has found that when agency "regulations are
unlawful, the ordinary result is that the rules are vacated not
that their application to the individual petitioner is
proscribed." National Mining Ass'n, 145 F.3d at 1409 (citation
omitted). In National Mining Ass'n, the district court
invalidated a Corps of Engineers regulation and entered an
injunction prohibiting the Corps and the Environmental Protection
Agency from enforcing the regulation nationwide.
145 F.3d at 1408. The D.C. Circuit upheld that nationwide application,
notwithstanding the fact that non-parties to the litigation would
specifically be affected. Id. at 1409-10.
Government-wide injunctive relief for plaintiffs and all
individuals similarly situated can be entirely appropriate and it
is "well-supported by precedent, as courts frequently enjoin
enforcement of regulations ultimately held to be invalid."
Sanjour v. United States EPA, 7 F. Supp. 2d 14, 17 (D.D.C.
1998). See, e.g., Harmon v. Thornburgh, 878 F.2d 484, 495 n. 21
(D.C. Cir. 1989) (court decision invalidating unlawful agency
regulation applies beyond just individual petitioners); Planned
Parenthood Fed'n of Amer., Inc., v. Heckler, 712 F.2d 650 (D.C.
Cir. 1983) (affirming final injunction prohibiting enforcement of invalidated regulations); Dimension Fin. Corp. v. Board of
Governors of the Fed. Reserve Sys., 744 F.2d 1402 (10th Cir.
1984) (enjoining Board from enforcing or implementing invalid
regulations) aff'd, 474 U.S. 361 (1986); Service Employees
Int'l Union v. General Servs. Admin., 830 F. Supp. 5 (D.D.C.
1993) (invalidating GSA regulation and enjoining further
enforcement of the rule).
The Supreme Court has also embraced this view. Although written
as part of a dissent, the D.C. Circuit has noted that it
expressed the views of all nine Justices. Justice Blackmun wrote:
The Administrative Procedure Act permits suit to be
brought by any person `adversely affected or
aggrieved by agency action.' In some cases, the
`agency action' will consist of a rule of broad
applicability; and if the plaintiff prevails, the
result is that the rule is invalidated, not simply
that the court forbids its application to a
particular individual. Under these circumstances, a
single plaintiff, so long as he is injured by the
rule, may obtain `programmatic' relief that affects
the rights of parties not before the court. On the
other hand, if a generally lawful policy is applied
in an illegal manner on a particular occasion, one
who is injured is not thereby entitled to challenge
other applications of the rule.
Lujan, 497 U.S. at 913 (Blackmum, J. dissenting) (citation
omitted). See also id. at 890 n. 2 (majority opinion) (noting
that under the APA, successful challenge by aggrieved individual
can affect the entire agency program) (as cited in National
Mining Ass'n, 145 F.3d at 1409).
However, defendants are correct in asserting that National Mining Ass'n did not address a mandatory rule that requires
district courts to issue nationwide injunctions as a matter of
law in all cases where agency regulations are invalidated.
Rather, the appropriate scope is in the court's discretion. See
145 F.3d at 1408-09 (noting the district court's "discretion in
awarding injunctive relief" and holding that when "a reviewing
court determines that agency regulations are unlawful, the
ordinary result is that the rules are vacated"). Courts retain
discretion to decline granting an injunction even where there is
a conceded violation of law. See Weinberger v. Romero-Barcelo,
456 U.S. 305, 312-13 (1982).
Defendants attempt to distinguish National Mining Ass'n from
the present case by noting that the injunction there prohibited
the enforcement by an agency of its own broadly applicable
regulation deemed by the court to be facially invalid. See
145 F.3d at 1408. Here, plaintiffs seek an injunction that would
prohibit DoD from taking action with respect to individual
members of the military. Defendants claims that this is much
broader than the injunction in National Mining Ass'n.*fn12 Defendants note that the relief in National Mining Ass'n was
also understandable in light of the broad representation of the
plaintiffs before the court there. That case involved a challenge
brought by several trade associations on behalf of their members.
145 F.3d at 1401. Defendants claim that the trade associations
represented a much broader cross-section of affected parties than
the six Doe plaintiffs.
However, it appears to this Court that the Court is faced with
precisely the circumstances described by Justice Blackmun in his
discussion of "programmatic relief." See also Purepac Pharm. Co.
v. Thompson, 238 F. Supp. 2d 191, 212 (D.D.C. 2002) (noting that
National Mining Ass'n stands for the "proposition that a
nationwide injunction invalidating an agency rule of broad
applicability is appropriate even where a single plaintiff has
challenged the legality of the rule"). Thus, the injunction
issued today shall apply to all persons subject to DoD's
involuntary anthrax inoculation program and not just the six Doe
plaintiffs. VI. Conclusion
This Court has an obligation to ensure that FDA follow the law
in order to carry out its vital role in protecting the public's
health and safety. By refusing to give the American public an
opportunity to submit meaningful comments on the anthrax
vaccine's classification, the agency violated the Administrative
Procedure Act. While the policy of submitting comments on an
agency's proposed order may be unusual, it is the course the
agency chose to take and this Court shall ensure that the agency
follows through on its commitment to the public.
Congress has prohibited the administration of investigational
drugs to service members without their consent. This Court will
not permit the government to circumvent this requirement. The men
and women of our armed forces deserve the assurance that the
vaccines our government compels them to take into their bodies
have been tested by the greatest scrutiny of all public
scrutiny. This is the process the FDA in its expert judgment has
outlined, and this is the course this Court shall compel FDA to
Accordingly, it is by the Court hereby
ORDERED that Plaintiff's Motion for Summary Judgment is
GRANTED. The FDA's Final Rule and Order is vacated and shall be
remanded to the agency for reconsideration in accordance with
this Memorandum Opinion and Order. Unless and until FDA properly classifies AVA as a safe and effective drug for its
intended use, an injunction shall remain in effect prohibiting
defendants' use of AVA on the basis that the vaccine is either a
drug unapproved for its intended use or an investigational new
drug within the meaning of 10 U.S.C. § 1107. Accordingly, the
involuntary anthrax vaccination program, as applied to all
persons, is rendered illegal absent informed consent or a
Presidential waiver; and it is further
ORDERED that, in light of the finding with regard to
Plaintiffs' Motion for Summary Judgment, Defendants' Motion for
Summary Judgment is DENIED.
A separate Order and Judgment accompanies this Memorandum