impasse. What was strange was that no one from Zuckerman Spaeder
was there with her in the room. Shoemaker had expected her to show
up accompanied by several of the firm’s partners, but there she was on
her own. She continued to invoke the firm’s legal advice, but no one
from the firm was present to attest to it.
The meeting ended with Shoemaker reiterating that he would need
to see something in writing from the FDA backing up Theranos’s
regulatory stance before he signed off on any experiment in
Afghanistan. Elizabeth agreed to get such a letter. She acted as if it was
a formality. Shoemaker very much doubted so, but at least things were
now clear: the ball was in Theranos’s court.
—
SHOEMAKER DIDN’T HEAR anything more about the matter until the
late spring of 2012, when he started receiving queries from CENTCOM
again. He couldn’t help but be annoyed. Not only had Theranos failed
to produce the letter he’d asked for, the company had gone completely
silent since he and Kelly had traveled to Washington to meet Elizabeth
in December.
With the approval of his boss, he decided to make contact with the
FDA himself. On the morning of June 14, 2012, he sent an email to
Sally Hojvat, the head of the agency’s microbiology devices division.
The two had worked together during Shoemaker’s FDA fellowship in
2003 and had just run into each other at a conference the previous
week. Shoemaker described to Hojvat the Theranos situation and,
calling the company’s regulatory approach “quite novel,” requested the
agency’s guidance on it. Although he didn’t intend his email as
anything more than an informal request for advice, it set off a
sequence of events that would have made him think twice about
sending it if he could have foreseen them.
Hojvat forwarded his query to five of her colleagues, including
Alberto Gutierrez, the director of the FDA’s Office of In Vitro
Diagnostics and Radiological Health. Gutierrez, who had a Ph.D. in
chemistry from Princeton, happened to have spent a not insignificant