Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
and in accordance with, the Part 16 proceedings.” 126
Although the Order was not effective due to the pending hearing request,
many potential recipients, including families who had previously had
children with Arsenault’s assistance and wanted to conceive genetically
related siblings, were thrown into a state of uncertainty by the FDA’s
actions. 127 Arsenault kept in communication with the FDA’s hearing
coordinator and stated, in accordance with Part 16. 24 (g), that he intended
to present and rely upon written information at the hearing: specifically,
“written statements signed by myself and the females who met with me
declaring that we are sexually intimate partners.” 128 However, months
passed with no response to his hearing request.
The Part 16 hearing process lacks many of the elements of due process
available in courts—or even in formal administrative proceedings. The
rules of evidence do not apply129 and there is no right to counsel. There is
no formal deadline for the agency to respond to a hearing request.
Although the requestor and the government both may file papers in support
or opposition, there are no strictures on the length, timing, or format of such
filings. The request itself is technically before the FDA Commissioner,
Margaret Hamburg, but Hamburg’s designee for these purposes is, as of this
writing and at the time of Arsenault’s request, Dr. Jesse Goodman, Chief
Scientist and Deputy Commissioner for Science and Public Health of the
FDA. Perhaps ominously, Dr. Goodman was, until only weeks before the
Arsenault investigation began, the Director of CBER—the very entity
whose order Arsenault sought to overturn. 130 A Part 16 hearing decision
could encompass only the grant or denial of a hearing, or also include the
substantive legal question of whether the Order was properly issued. A
decision could be made at any time, with or without further information
from the requestor.
Finally, on February 11, 2011, something happened: CBER filed a
motion opposing Arsenault’s request. CBER’s motion asked that its former
director deny the request for an evidentiary hearing and grant administrative
summary judgment on the question of whether 21 C.F.R. Part 1271 legally
applies to Arsenault’s conduct.
The government’s chief argument was that no genuine or substantial
127. Trent Arsenault, Order from CBER to Cease Manufacturing of Semen and Hearing
Commissioner-Hamburg-trentdonor-2010-1128.pdf (Nov. 28, 2010) (pleading for
128. Pls.’ Mot. Opp. CBER’s Mot. Summ. J. 1, Nov. 7, 2011.
129. 21 C.F.R § 16. 60 2(c) (2012).