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 at heart.

For the 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.

I am 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. 

I.          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 application. 

A variety of court decisions validate FDA’s requirement that “new” drugs are not licensed and must seek separate FDA approval.  See 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. 

A.                The AVA has been placed in IND status by its manufacturer in order to receive FDA approval for using the AVA to protect against inhalation anthrax.

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 pulmonary anthrax.  Id.

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 added).

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, infra.  However, 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.

B.                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. 

C.                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.  Accordingly, under FDA 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 DoD agencies. 

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.

It is 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 informed consent.

D.        A Federal Statute and a Presidential Order Require Informed Consent From Service Members Prior To The Administration Of The Anthrax Vaccine

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.

1.                  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:

(a)                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 (d).

(b)               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.

(c)                Form of Notice. - The notice required under subsection (a)(1) shall be provided in writing.

(d)               Content of Notice. - The notice required under subsection (a)(1) shall include the following:

(1)               Clear notice that the drug being administered is an investigational new drug or a drug unapproved for its applied use.

(2)               The reasons why the investigational new drug or drug unapproved for its applied use is being administered.

(3)               Information regarding 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.

* * *

(e)                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 consent –

(1)               is not feasible;

(2)               is contrary to the best interests of the member; or

(3)               is not in the interests of national security. 

(emphasis added).

2.                  The Order of the President.

On September 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: 

Sec. 2.  Administration of Investigational New Drugs to Members of the Armed Forces. 

(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. 

(emphasis added).

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 AVA. 

II.        The Military Justice System

The 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 orders.  Properly 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.

The 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).

It is 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. 

If a 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 proceeding.

If a 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 general.  Summary 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. 

A 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. 

The 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.