Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
264 (2012)]. The agency has determined that because your
Establishment is in violation of 21 CFR Part 1271, your
Establishment does not provide adequate protections against the
risks of communicable disease transmission through the use of
these HCT/P’s. This Order to Cease Manufacturing relates to
conduct occurring on or after May 25, 2005, the effective date of
the applicable regulations. FDA retains the authority to pursue
other actions and remedies.
Because of your failure to provide adequate protections against the
risks of communicable disease transmission, pursuant to 21 C.F.R.
Part 1271.440(a)( 3), you must cease manufacturing until
compliance with the regulations in 21 C.F.R. Part 1271 has been
achieved and you have been provided written authorization from
FDA to resume operations. Under 21 C.F.R. Part 1271.3(e),
manufacture means, but is not limited to, any or all steps in the
recovery, processing, storage, labeling, packaging, or distribution
of any HCT/P, and the screening or testing of the HCT/P donor.
The Order was to be effective either five working days from its issuance
or after a hearing and determination, if such was requested by Arsenault. 123
Arsenault immediately responded with a letter addressed to FDA Directors
Barbara Cassens and Mary Malarkey, requesting a hearing and describing
his relationships with the recipients. 124 Apparently for the first time,
Arsenault informed the FDA in writing that he considered himself exempt
from the 21 C.F.R. Part 1271 directed donor requirements because he fell
within the “sexually intimate partner” exception. On November 11, 2010,
Arsenault confirmed that his November 1, 2010 response had been intended
to invoke the Part 16 hearing process under 21 C.F.R. Part 1271.440(e). 125
The next day, the FDA formally acknowledged the request, informing him
that “the Order to Cease Manufacturing will be effective after a decision in,
123. Given that the Order was not effective immediately, there is reason to believe that
CBER did not conclude that there were reasonable grounds to believe that Arsenault’s
conduct as a threat to public health. See 21 C.F.R. § 1271.440(a)( 3) (“When FDA
determines there are reasonable grounds to believe there is a danger to health, such order will
be effective immediately. In other situations, such order will be effective after one of the
following events, whichever is later: ( i) Passage of 5 working days from the establishment’s
receipt of the orderFalse”).
124. Trent Arsenault, Letter from Trent Arsenault to FDA (Nov. 1, 2010), available at
doc-01-nov-2010.pdf (replying to the FDA’s Cease Manufacturing order, making a hearing
request, and reply to Form 483).
125. Stephany Wesley, Order for Cessation, CBER, (Nov. 12, 2010),
cease-order-12-nov-trentdonor-2010.pdf (confirming the Cease Manufacturing order would
be effective after a Part 16 hearing).