House Lawmakers To Review New Policies For Anthrax

Vaccinations

by Keith J. Costa

Inside The Pentagon

May 4, 2000

The House Armed Services military personnel subcommittee today will consider legislation designed to establish new policies and procedures for the Defense Department's mandatory anthrax vaccine program.

The legislation, drafted by Rep. Walter Jones (R-NC), a longtime critic of the Pentagon's vaccine effort, has been included in the subcommittee chairman's mark of the fiscal year 2001 defense authorization bill. The subcommittee chairman is Rep. Steve Buyer (R-IN).

If enacted, the bill would direct the Pentagon to develop a "vaccine development and procurement plan." It also includes language requiring the defense secretary to establish a "system for tracking, recording and reporting separations of members from the armed forces as a result of a refusal to participate in the anthrax vaccine immunization program."

Based on the information culled from such a system, the defense secretary would be required to submit annual reports to the House and Senate Armed Services Committees detailing:

"The number of personnel separated, categorized by military department, rank and active-duty or reserve status; and "Any other information determined appropriate by the secretary."

Lawmakers who support the legislation hope such information will allow the Pentagon and Congress to assess the full readiness impact of the immunization program.

Another provision calls on the defense secretary to establish a separate system for monitoring adverse reactions among vaccinated military personnel. The system must include the following elements:

*"Independent review of Vaccine Adverse Event Reporting System reports; "Periodic surveys of personnel to whom the vaccine is administered; "A continuing longitudinal study of a pre-identified group of members of the armed forces (including men and women and members of all services); [and] "Active surveillance of a sample of members to whom the anthrax vaccine has been administered that is sufficient to identify, at the earliest opportunity, any patterns of adverse reactions, the discovery of which might be delayed by reliance solely on [VAERS]."

VAERS is managed jointly by the Food and Drug Administration and the Centers for Disease Control and Prevention for tracking adverse reaction to vaccines. In addition to VAERS, the Pentagon has developed its own database for tracking shots administered to service members.

If made law, the chairman's mark would direct the defense secretary to establish uniform procedures "under which [service members] may be exempted from participating in the anthrax vaccination program for either administrative or medical reasons."

The bill also addresses DOD's civilian employees who may be required to take anthrax vaccine shots: "The secretary of defense shall prescribe regulations for the purpose of ensuring that any civilian employee . . . who is determined to be an emergency essential employee and who is required to participate in the anthrax vaccine program is notified of the requirement to participate and the consequences of a decision not to participate."

Further, DOD must inform potential new hires about employee obligations under the vaccine program.

The defense secretary is also tasked with producing a development and procurement plan "for modernizing all vaccines used or anticipated to be used as part of the protection strategy" for service members.

To that end, the defense secretary "shall, to the maximum extent possible, be the sole purchaser of a vaccine to immunize members of the armed services and employees of all federal agencies .. . [and] procure such a vaccine from more than one manufacturer."

If DOD determines a sole-source contract is necessary to procure anthrax vaccine, the defense secretary must first notify Congress before agreeing to buy the drug from a single manufacturer.

The legislation would also mandate that the Pentagon compile annual reports for congressional authorizers for the next four years examining payments made to anthrax vaccine program contractors, as well as costs associated with the effort.

The first report, which would be due April 1, 2001, would include the following:

*"An estimate of the life-cycle cost for the anthrax vaccination program;

*"A description of the acquisition strategy for the program, including the applicable acquisition category;

*"An assessment of the government-wide requirements with respect to the anthrax vaccine and the financial and manufacturing ability of the manufacturer of the anthrax vaccine to meet such requirements;

*"A description of the status of supplements to the anthrax vaccine licenses of the contractors and whether the Food and Drug Administration has approved or is anticipated to approve all anthrax vaccine doses manufactured;

*"A summary of all audits by the Defense Contract Audit Agency or the [DOD] Inspector General . . . of anthrax vaccine contracts of the Department of Defense and a description of any actions taken or planned to be taken in response to recommendations regarding such audits; [and]

*"A review of all actions taken by [DOD] to coordinate with other federal agencies to ensure the facility of a manufacturer of the anthrax vaccine is compliant with all federal requirements."

The legislation calls on the General Accounting Office to conduct its own review of the anthrax vaccine program. For example, the GAO's comptroller general must submit a report to congressional authorizers describing the program's impact on military recruitment and retention by April 2001.

Furthermore, "the comptroller general shall include in the report . . . a description of any personnel actions -- including transfer, termination, or reassignment of any personnel -- taken as a result of the refusal of any civilian [DOD] employee to participate in the anthrax vaccination program," it states.