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 Admin