Mr. Chairman, distinguished members of the Committee, I
want to thank you for the opportunity to address you today on an issue
that I believe directly affects our most important national security
resource, the men and women of our Armed Forces. The mandatory anthrax
vaccination program, or AVIP, has not only failed in its stated goal of
providing adequate protection to all members of the active duty and
active reserve forces, but has caused many service members to question
whether their civilian and military leadership has their best interest
Committee’s information, I would like to provide a brief personal
history. I graduated from
the United States Air Force Academy in 1977 and attended navigator and
electronic warfare officer training. Following an initial assignment
to long range reconnaissance aircraft for the Strategic Air Command, I
was selected to attend law school under an Air Force program and entered
Duke University in 1982.
Following law school, I became a member of the Air Force Judge
Advocate General’s Department and served in various JAG assignments
until I left active duty in 1991.
Since leaving active duty I have been in private practice with
the law firm of McGuireWoods.
I am currently a Lieutenant Colonel in the Air Force
Reserve. I am testifying in
my personal capacity today.
not a specialist in medical law, but got involved in the anthrax
vaccination issue when a friend asked me to assist him in the
representation of Air Force Major Sonnie Bates. You may remember Major Bates as
the most senior Air Force officer to refuse the anthrax shot. My colleague, Air Force Reserve
Major Bruce Smith and I prepared Major Bates’ defense and researched the
defenses to the charge of violating a lawful order. Our research uncovered the fact
that the manufacturer of the vaccine, Michigan Biologic Products, Inc.,
filed an investigational new drug (“IND”) application with the Food and
Drug Administration (“FDA”) for the vaccine in 1996. This fact, when coupled with the
legal requirements of 10 U.S.C. § 1107 and Presidential Executive Order
(“E.O.) 13139, both of which prohibit administration of an
investigational new drug to members of the Armed Forces without their
informed consent, renders illegal orders to take anthrax vaccine
absorbed (“AVA”) shots. The
purpose of my testimony today is to explain why orders to take the
vaccine are illegal under military law.
The Illegal Orders
The key to understanding why the AVA vaccinations are
illegal revolves around the status of the vaccine as an IND. The term “IND” is a term of art
under FDA regulations and refers to a status given to a substance for
which FDA approval is being sought for, among other things, how the
substance is used, a change in formulation, a change in route of
administration, or repackaging.
See 21 C.F.R. § 312 (1999).
The term “IND” also embraces so-called “new” drugs as
defined by the FDA itself.
See 21 C.F.R. § 312.3(b) (cited in E.O. 13139). A drug is considered a “new”
drug, even if it has been in use for years, if there is a proposed
change in the use of the product, a change in its formulation or
dilution, or changes similar to those required for an IND
A variety of court decisions validate FDA’s requirement
that “new” drugs are not licensed and must seek separate FDA
e.g., Hoffman v. Sterling Drug, Inc., 485 F.2d 132 (3rd
Cir. 1973) (marketing a drug previously approved by the FDA for the
treatment of malaria as suitable for treating lupus caused the already
approved drug to be considered a “new drug” as far as the lupus
treatment was concerned); U.S. v. Articles of Drug, etc., 442 F.
Supp. 1236 (S.D.N.Y. 1978) (a drug may be considered “new” if there is a
change in the dosage, or method of administration or application, or
other condition of use prescribed, recommended or suggested in the
labeling of such a drug, even if the drug has previously been approved
with a different dosage and for a different purpose). Accordingly, federal statutes,
regulations and case law show that even an established and licensed drug
such as the AVA that is modified with regard to its dosage regimen or
purpose for which it is being offered is an “IND”, and therefore covered by the requirements of
Executive Order 13139 and 10 U.S.C. § 1107.
The AVA has been placed in IND status by its manufacturer
in order to receive FDA approval for using the AVA to protect against
The license for the AVA, approved in 1970 by the
National Institute of Health, indicates that it was approved as a
prophylaxis against anthrax resulting from
contact with animal products such as hides, hair, or
bones which comes from anthrax endemic areas that may be contaminated
with Bacillus anthracis
spores; and for individuals engaged in diagnostic or investigational
activities which may bring them into contact with B. Anthracis spores… it is also
recommended for high risk persons such as veterinarians and others
handling potentially infected animals.
Anthrax Vaccine Adsorbed, Package insert, Michigan
Department of Public Health (“MDPH”), October 1987.
Because the AVA license contained no specific indication
for inhalation anthrax, in 1995 the owner of the vaccine, MDPH, and the
United States Army discussed establishing a plan for FDA approval of an
inhalation anthrax indication.
In October 1995 the Joint Program Manager for the DoD Biological
Defense program attended an information meeting prepared by defense
contractor Science Applications International Corporation (“SAIC”) to
discuss a plan. The purpose
of the SAIC meeting was to
provide the Director, Medical Biological Defense
Research Program with a project plan to obtain an amendment to the
Anthrax Vaccine product license… [to] obtain indication for protection
against aerosol exposure.
See Anthrax Vaccine License Amendment Project Plan
briefing slides (October 20, 1995).
Documents attached to the briefing slides show clearly
that the plan in the fall of 1995 was to get FDA approval to change the
immunizational schedule (in this case from a series of six prescribed
doses to three doses), and to change the vaccine labeling to reflect
that the vaccine was properly administered as protection against
Minutes of the October 1995 meeting also reflect that
the focus of the project was to obtain a label indication change
concerning the prevention of pulmonary anthrax. The meeting ended with Brigadier
General Walter L. Busbee, Joint Program Manager for Biological Defense,
U.S. Army, directing that participants were to continue the process of
developing “an option package for initiating and completing amendment to
the… anthrax license for:
(1) a reduced immunization schedule, (2) immunization by the
intramuscular route, and (3) indication for protection against an
aerosol challenge.” Minutes
of the Meeting on Changing the FDA License for the MDPH Anthrax Vaccine
to Meet Military Requirements, November 13, 1995. It is worth noting that slides
associated with these minutes state that there is “insufficient data to
show efficacy against inhalation anthrax.” Id.
Less than one year from the date of the briefing, on
September 20, 1996, the vaccine manufacturer, MBPI, filed an “initial”
Investigational New Drug Application for AVA. The purpose of the application
was to “conduct clinical investigations designed to investigate changes in
the approved labeling for the licensed product. The potential labeling changes
would effect a specific clinical indication, route and vaccination
schedule for AVA.”
See Cover Letter, MBPI IND Application, September 20, 1996
(emphasis added). The cover
form shows three specific bases for the application, including
“inhalation anthrax” exposure.
Of particular note is the Introductory Statement filed
with the IND application.
In ¶ 3.1 of the Statement, MBPI states
the ultimate purpose of this IND is to obtain a specific indication for
inhalation anthrax and a reduced vaccination schedule (emphasis
MBPI IND Application.
This IND application by MBPI, which has remained open,
unmodified and current, clearly shows that the Army and the
manufacturer, MBPI (now Bioport) moved to place the AVA in IND status in
order to get a labeling change showing the AVA was effective against
aerosol anthrax exposure.
The filing of the IND application by MBPI places the AVA in IND
status, allowing for FDA-approved clinical testing, as well as
interstate transport of the vaccine for testing purposes. As of today, under the FDA
regulations the vaccine is an IND for the purposes for which the
application was filed, namely, for a change in the labeled use to
encompass inhalation anthrax.
The DoD’s assertion that, at a later date, the FDA has
somehow “approved” the vaccine for inhalation anthrax is factually and
legally baseless as will be demonstrated in Section C,
nothing that various FDA officials say alters the simple fact that the
manufacturer, by its application to FDA, squarely placed the AVA in IND
status as a preventative against inhalation exposure to anthrax and for
a reduced vaccination schedule. This is the key point to
understanding why orders to take the shots are illegal: The vaccine is in an IND
status for inhalation prophylaxis (and for an altered vaccination
schedule), and has been since the manufacturer, at the Army’s request,
filed its IND application in September 1996.
The Committee should note that DoD does not have the
responsibility or the authority to place the AVA in IND status or to
take it out of IND status.
DoD is not the manufacturer of the vaccine; only the manufacturer
can file the IND application.
And, in fact, the manufacturer has done just that and is
presumably complying with IND rules.
The AVA is an IND because the DoD, as a matter of policy,
is not following the licensed vaccine schedule.
In addition to seeking a specific FDA license approval
for use against inhalation anthrax, the IND application seeks to modify
the licensed vaccination immunization schedule of three subcutaneous
injections given two weeks apart, followed by three additional
subcutaneous injections given at six, twelve and eighteen months. See MBPI IND Application
and AVA package insert (October 1987). Under federal law and FDA
regulations, altering the vaccination schedule for the current AVA would
be improper, because the deviation from the licensed and approved
schedule makes the vaccine a “new” and investigational drug, and also
brings it under the aegis of the IND application.
FDA officials, in fact, have advised DoD that
[I]f the military is interested in using a vaccination
time schedule different from the currently licensed schedule for a mass
vaccination effort, then informed consent would be appropriate.
February 18, 1997 Memorandum from Dr. Karen L.
Goldenthal, an FDA physician responding to a telephone call from Admiral
Martin re: Anthrax Vaccine.
Although DoD maintained in court filings as late as last
summer that it “specifically follows the FDA approved immunization
schedule for the vaccine,” it is now a matter of policy that members of
the Armed Forces will not be vaccinated on the approved schedule
contained in AVA labeling.
DoD’s public announcements, following the failure of the AVA
manufacturer, Bioport, to manufacture vaccine that would pass FDA
testing, are clear. The current DoD policy is that soldiers who have
received some, but not all, of the shots will not have to repeat the
initial sequence of shots, even though they may not receive additional
shots for up to two years.
The product label for the AVA specifies an immunization schedule
of three injections given two weeks a part followed by additional three
injections at six, twelve and eighteen months. DoD’s straightforward disregard
of the labeling requirements provides further indication of the IND
nature of the AVA as it is being used by DoD today. On this basis alone, a court
could properly find the FDA to be an IND and subject to the requirements
of 10 U.S.C. § 1107 and EO 13139.
The FDA letters relied on by DoD to support its position
that the AVA is not an IND have no legal effect and are entitled to no
deference by the Court.
In an apparent effort to reinforce the untenable
position that the AVA is properly licensed, various DoD officials asked
FDA representatives to opine on whether the AVA was appropriately used
as a prophylaxis against inhalation anthrax.
Unfortunately, none of these letters has any legal
viability under the FDA’s own regulatory system. Cognizant of the fact that
outside entities might place undue reliance on the private informal
opinions of FDA staff, the FDA drafted strict requirements for what it
refers to as “advisory opinions” that might bind or commit the
agency. 21 C.F.R. §
10.85(k) specifically states:
a statement made or advice provided by an FDA employee
constitutes an advisory opinion only if it is issued in writing under
this Section. A statement
or advice given by an FDA employee orally, or given in writing but not
under this Section or § 10.90 is an informal communication that
represents the best judgment of that employee at that time but does not
constitute an advisory opinion, does not necessarily represent the
formal position of the FDA, and does not bind or otherwise obligate or
commit the agency to the views expressed.
None of the letters relied on by DoD as “proof” that the
AVA is not an IND were issued under either of the 21 C.F.R. Sections
listed in the regulations.
these letters are merely “informal communications” that have absolutely
no legal effect. As such,
these letters cannot modify the clearly defined legal status of the AVA
that results from the filing of the IND application by MBPI, or by
variations in the vaccination schedule currently authorized by various
Further proof of the letters’ limited scope is contained
in the recent Supreme Court decision in Christensen, et al. v. Harris
County, et al., ___ U.S. ___, 120 S.Ct. 1655, 2000 U.S. LEXIS 3003
(May 1, 2000). The Supreme
Court specifically found that agency opinion letters are not entitled to
deference by the Court but only to “respect,” and then only to the
extent that the letters’ interpretations are persuasive. Christensen, 2000 U.S.
LEXIS 3003 at *19-20. Given
that the letters offered by DoD as validation of its position regarding
the IND status of the AVA are not agency approved letters, do not
incorporate agency approved positions, and fly directly in the face of
clear language in an IND application, this Committee should find that
these letters are unpersuasive and without legal effect.
Indeed, there could be no other result, given the fact
that the letters are totally at odds with the IND application
language. It makes
absolutely no sense to believe that FDA officials writing in their
personal capacity can single-handedly invalidate the regulatory scheme
adopted by the FDA to prevent the licensing and interstate movement of
Investigational New Drugs.
clear from the IND application, the use schedule, and the legally
invalid FDA letters that DoD’s position is untenable. The AVA is an IND. Under federal law and Executive
Order it may not be given to members of the Armed Forces without their
A Federal Statute and a Presidential Order Require
Informed Consent From Service Members Prior To The Administration Of The
A determination that the AVA is
an IND renders inescapable the conclusion that service members as a
consequence of federal law and service regulations must give their
informed consent prior to submitting to vaccinations.
The Federal Statute.
10 U.S.C. § 1107 (1999) entitled
“Notice of Use of an Investigational New Drug or a Drug Unapproved for
its Applied Use” specifically provides:
Notice Required. -
(1) Whenever the Secretary of Defense requests or requires a member of
the armed forces to receive an investigational new drug or a drug
unapproved for its applied use, the Secretary shall provide the
member with notice containing the information specified in subsection
Time of Notice. - The
notice required to be provided to a member under subsection (a)(1) shall
be provided before the investigational new drug or drug unapproved for its applied
use is first administered to the member.
Form of Notice. - The
notice required under subsection (a)(1) shall be provided in writing.
Content of Notice. -
The notice required under subsection (a)(1) shall include the following:
Clear notice that the
drug being administered is an investigational new drug or a drug
unapproved for its applied use.
The reasons why the
investigational new drug or drug unapproved for its applied use is being
the possible side effects of the investigational new drug or drug
unapproved for its applied use, including any known side effects
possible as a result of the interaction of such drug with other drugs or
treatments being administered to the members receiving such drug.
* * *
Limitation and Waiver. - (1) In the
case of the administration of an investigational new drug or a drug
unapproved for its applied use to a member of the armed forces in
connection with the member's participation in a particular military
operation, the requirement that the member provide prior consent to
receive the drug in accordance with the prior consent requirement
imposed under section 505(i)(4) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(i)(4)) may be waived only by the President. The President may grant such a
waiver only if the President determines, in writing, that obtaining
is not feasible;
is contrary to the
best interests of the member; or
is not in the
interests of national security.
The Order of the President.
30, 1999, the President issued Executive Order 13139, entitled
“Improving Health Protection of Military Personnel Participating in
Particular Military Operations”.
EO 13139 provides in pertinent part:
Administration of Investigational New Drugs to Members of the
(a) The Secretary of Defense (Secretary) shall
collect intelligence on potential health threats that might be
encountered in an area of operations. The Secretary shall work
together with the Secretary of Health and Human Services to ensure
appropriate countermeasures are developed. When the Secretary considers an
investigational new drug or a drug unapproved for its intended use
(investigational drug) to represent the most appropriate countermeasure,
it shall be studied through scientifically based research and
development protocols to determine whether it is safe and effective for
its intended use.
(b) It is the expectation that the United States
Government will administer products approved for their intended use by
the Food and Drug Administration (FDA). However, in the event that the
Secretary considers a product to represent the most appropriate
countermeasure for diseases endemic to the area of operations or to
protect against possible chemical, biological, or radiological weapons,
but the product has not yet been approved by the FDA for its intended
use, the product may, under certain circumstances and strict controls,
be administered to provide potential protection for the health and
well-being of deployed military personnel in order to ensure the success
of the military operation.
The provisions of 21 CFR Part 312 contain the FDA requirements
for investigational new drugs.
Sec. 3. Informed Consent Requirements
and Waiver Provisions.
(a) Before administering an
investigational drug to members of the Armed Forces, the Department of
Defense (DoD) must obtain informed consent from each individual unless
the Secretary can justify to the President a need for a waiver of informed
consent in accordance with 10 U.S.C. 1107(f). Waivers of informed consent will
be granted only when absolutely necessary.
In addition, the provisions of
21 C.F.R. §§ 50, 312 (October 5, 1999) support both the federal statute
and the Executive Order by specifically noting situations where the
informed consent requirements may be waived. Echoing 10 U.S.C. § 1107, the
Regulations note that only the President of the United States may waive
the informed consent requirements mandated by his Executive Order and
federal law. Waiver is
allowed only if one of three preconditions is met – if obtaining
informed consent is not feasible; if obtaining informed consent is
contrary to the best interests of the recipient; or if informed consent
is contrary to national security interests. The President has yet to issue
any such waivers, or even initiate action to do so regarding the
The Military Justice System
Committee has also requested that I provide an overview of the
differences between the military and civilian judicial processes as they
relate to the anthrax vaccination issue. I will attempt to do so,
however, the discussion here obviously will not be exhaustive.
Military offenses that
relate to the issue of the AVIP are defined in Articles 90 and 92, which
discuss which discuss willful disobedience of lawful commands or
promulgated orders and regulations are presumed to be lawful under
military law, although the prosecution must establish unlawfulness if
the defense is successfully able to raise the issue. Depending on the circumstances,
refusal to follow an order may be punished administratively, through
non-judicial punishment under the Uniform Code of Military Justice
(“UCMJ”) or at a court-martial, which may impose a wide variety of
sentences up to and including death.
defenses to a change of refusal to follow a lawful command or order are
varied, and can range from lack of authority on the part of the entity
giving the order, to overbreadth or unreasonableness. Other potential defenses include
justification, necessity, duress, inability or ignorance or
mistake. In the case of
orders to submit to anthrax vaccination, the most likely defense is that
the order conflicts with a statutory right of the person receiving the
order, i.e., the right to provide informed consent to the vaccination
under 10 U.S.C. §1107, or E.O. 13139. See Manual for Courts – Martial,
Part IV, Paragraph 14.c.(2)(a)(iv)(1998).
not uncommon for a service member accused of refusing a lawful order to
be offered an additional opportunity to comply with the order. Once it has been established
that the service member will not comply, a commander may impose
punishment either through administrative means or under the UCMJ. This is completely
different from the civilian legal system, in which all criminal cases
are disposed of in a judicial setting. Administrative punishments can
range from reprimands up to and including administrative separation from
the Armed Forces, with a
service characterization of either an honorable discharge, a
general discharge (under honorable conditions), or a discharge under
other than honorable conditions.
commander believes that administrative sanctions are not sufficient, she
may impose punishment under Article 15 of the UCMJ which allows for a
relatively quick process in which the commander can impose relatively
minor punishments for relatively minor offenses. Typically under an Article 15
proceeding, the commander advises the service member that the service
member is believed to have committed an offense under the UCMJ. The service member then responds
either in writing or with an oral presentation, or both, to the
commander, who then makes the decision whether to impose punishment and
to what extent. Maximum
punishments are limited given the limited due process nature of the
commander feels the offense is substantial, she may decide to press the
matter forward to a court-martial.
There are three types of court-martial: summary, special and
court-martial is a simplified, expedited procedure conducted before a
commissioned officer who may, but need not be, a lawyer. A service member must consent to
a summary proceeding, and is not normally entitled to a detailed defense
attorney although he may use civilian counsel. Witnesses are called and the
military rules of evidence are in effect, but only enlisted members may
be tried by summary court-martial.
The maximum punishments are quite limited.
special court-martial is conducted before either a military judge or a
military judge and panel, or jury, of three service members. Trial counsel and defense
counsel are appointed to the court and the accused has the right to be
represented by a detailed defense counsel or a civilian attorney. Any service member may be tried
by a special court-martial for any non-capital offense. The maximum punishments include
confinement for six months and forfeiture of two-thirds pay for six
months, as well as a bad conduct discharge.
general court-martial proceeding provides a substantial level of
procedural due process.
Before convening a general court-martial, the convening authority
must order a pretrial investigation and receive a legal opinion as to
disposition of the charges.
General court-martial may be conducted before a military judge or
before a military judge and a panel of at least five members. The only limits upon a sentence
that can be imposed by a general court-martial are those limited for
each offense in the UCMJ and can include the death penalty, a bad
conduct discharge, or a dismissal for officers.