Requiring the Use of a Vaccine Subject to an Emergency Use Authorization
17
waiver authority in section 1107a paralleled the one in 10 U.S.C.
§ 1107(f
), which does effectively prohibit the administration of an IND
product in a clinical trial without first obtaining the individual’s affirma-
tive, informed consent. See supra note 15 (distinguishing these waiver
authorities).
16
As explained, however, that intent or expectation is not
realized in the text of section 564(e)(1)(A)(ii)(III), which section 1107a
expressly cross-references. Cf. Steinle v. City & Cty. of San Francisco,
919 F.3d 1154, 1164 n.11 (9th Cir. 2019) (“[T]he plain and unambiguous
statutory text simply does not accomplish what the Conference Report
says it was designed to accomplish.”); Goldring v. Dist. of Columbia, 416
F.3d 70, 75 (D.C. Cir. 2005) (“A sentence in a conference report cannot
rewrite unambiguous statutory text[.]”).
17
We therefore conclude that
section 1107a does not change our interpretation of section 564 of the
FDCA.
As for DOD’s concern about service members who would lack a mean-
ingful option to refuse EUA products because of the prospect of sanction,
including possibly prosecution, we note that any difference between our
view and the assumption reflected in the conference report should have
limited practical significance. Given that FDA has imposed the “option to
accept or refuse” condition for the COVID-19 vaccines by requiring
16
It is possible the conferees assumed that the new EUA legislation would, in effect,
carry over from the earlier IND provision of the FDCA, see supra Part I.A and note 11,
the condition that a covered product may not be administered to an individual without that
person’s express, informed consent—a condition that applies to the military when it
undertakes the sort of clinical trial with an IND that 21 U.S.C. § 355(i) governs, see supra
note 11. Congress did not include such a consent requirement in section 564, however,
perhaps because EUA products are not limited, as INDs are, to use in human clinical
trials, but are instead authorized for more widespread use in the case of a declared emer-
gency. See supra Part I.A and notes 11 & 15.
17
Moreover, the legislative history as a whole is not uniform on this point. The earlier
House report, for instance, described the condition in purely informational terms. See
H.R. Rep. No. 108-147, pt. 3, at 33 (2003) (“New section 564(k) [an earlier but similarly
worded version of what became 10 U.S.C. § 1107a] pertains to members of the Armed
Forces and, among other things, it specifies that the President may waive requirements
designed to ensure that such members are informed of the option to accept or refuse
administration of an emergency use product, upon certain findings[.]” (emphasis added));
see also Milner v. Dep’t of the Navy, 562 U.S. 562, 574 (2011) (noting that “[l]egislative
history, for those who take it into account, is meant to clear up ambiguity, not create it,”
and thus, “[w]hen presented, on the one hand, with clear statutory language and, on the
other, with dueling committee reports, we must choose the language”).