Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
issues of fact existed to justify the use of FDA resources conducting a
hearing. Citing the section’s preamble, CBER noted that “the primary
purpose of a Part 16 hearing is to resolve factual issues.” 131 Under §
16. 26(a), “the person requesting the hearing” bears the burden of producing
“information . . . to show that there exists a genuine and substantial issue of
fact.” 53 Fed. Reg. 4,613, 4,614 (Feb. 17, 1988). In this case, Arsenault
has offered to produce, at a hearing, written and oral testimony by himself
and some of the recipients describing their relationship. These statements
would be offered to resolve the factual question of what type of relationship
existed between the donor and recipient—a necessary precondition to
determining whether the sexually intimate partner exception could apply.
CBER argued that Arsenault’s new evidence constituted “mere
allegations” 132 that “disputed FDA’s application of its own regulations,” 133
and did not raise a genuine or substantial issue of fact. CBER stressed that
these statements were inconsistent with documentation produced to FDA
inspectors during their investigation: numerous statements by Arsenault,
such as those in donor agreements, his FDA registration form, and his
website, described him as a “directed donor.” 134 CBER also recapped the
various regulations under 21 C.F.R. Part 1271 with which Arsenault failed
to comply before asking the Commissioner to reject the hearing request,
[Arsenault’s] explanation, that he is the sexually intimate partner
with those to whom he donates, is nothing more than an attempt to
skirt the law and is offered without a shred of evidence. FDA
cannot accept an expanded definition of the term ‘sexually
intimate partner’. To do so, would create a hurdle for the very
individuals Mr. Arsenault claims to be helping. It would create a
hurdle to the protections offered by the donor eligibility
CBER’s attempt to short-circuit the hearing process and affirm the
issuance of the Order did not produce results. Months passed with no
action from the Commissioner on either Arsenault’s request or CBER’s
filing. However, the provision permitting Arsenault to donate during the
pendency of the hearing request functioned to increase the stakes, as
Arsenault’s decision to continue responding to potential recipients resulted
in even more donations—and pregnancies.
53 Fed. Reg. 4614 (Feb. 17, 1988).
CBER’s Mem. Supp. Mot. To Deny Hearing Req. & Summ. J. 8, Feb. 7, 2011.
Id. at 10.
Id. at 9.