Chapter Seven

Postscript

In July 1997, as indicated above, FDA issued "Accessibility to New Drugs for Use in Military and Civilian Exigencies When Traditional Human Efficacy Studies Are Not Feasible; Determination Under the Interim Rule That Informed Consent is Not Feasible for Military Exigencies; Request for Comments," (62 FR 40996, July 31, 1997). This request asked for public comment on issuing the Interim Rule unchanged as a final rule, modifying the rule, or revoking it.

It was anticipated at the time of the Request for Comments that this action would subsequently result in an FDA proposed decision, which in turn would be published as an NPRM. Formal publication of an NPRM had not occurred by the summer of 1998, although it was known that FDA had submitted to OMB for clearance a proposal (i.e., a draft NPRM) to revoke the Interim Rule. This proposal was not a public document. It was also known, although not formally public, that DoD had objected to revocation.

During the summer of 1998, the "Bryd amendment" (S. 2057, July 20, 1998) was included in the Senate national defense authorization bill for fiscal year 1999. This amendment would have removed the authority to submit waiver requests under the Interim Rule from ASD(HA) and vested that authority in the Secretary of Defense. The proposed amendment further required that the President concur in this request, by a written statement, and that the chairman and ranking minority member of each "congressional defense committee" be notified of this action. If enacted, however, the amendment required that the Interim Rule, or its equivalent, authorizing such waivers continue in effect. Given the FDA proposal to revoke the Interim Rule, the possibility existed briefly, and perhaps only hypothetically, that a statute would be enacted authorizing the Secretary of Defense to request implementation of a nonexistent FDA regulation.

The Gordian knot was cut in a modified version of the Byrd amendment, included as Sec. 731 of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (Public Law 105-261, October 17, 1998). This amendment, entitled "Process for Waiving Informed Consent Requirement for Administration of Certain Drugs to Members of Armed Forces for Purposes of a Particular Military Operation," pertained to "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." It provided that the requirement of prior consent for receipt of such a drug under the FDCA "may be waived only by the President."

The President, in granting waivers under this provision, must determine in writing "that obtaining consent--(A) is not feasible; (B) is contrary to the best interests of the member; or (C) is not in the interests of national security." In reaching such a determination, the President "shall apply the standards and criteria that are set forth in the relevant FDA regulations for a waiver of the prior consent requirement on that ground." The relevant FDA regulations are specified as those "promulgated under section 505(i) of the FDCA; the prior consent requirements are those specified under section 505(i)(4)." The notification of the Committee on Armed Services and the Committee on Appropriations of the Senate, and the Committee on National Security and the Committee on Appropriations of the House of Representatives are required of any waivers granted under this provision.

Thus, the issue of authority has been decisively resolved. The granting of waivers of informed consent is now, by statute, recognized as not only a scientific and clinical issue, but one that requires the engagement of the highest political authority under the Constitution, the President of the United States, with full knowledge of the relevant congressional committees. The defense against CW/BW weapons of mass destruction has thus been elevated to the level of the Commander in Chief. Questions of implementation now must be clarified. Presumably, issues of dealing with chemical and biological terrorism will now also engage Presidential authority.


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