adamant and he was also getting second-guessed by CENTCOM, he
decided to bring in Jeremiah Kelly, an army lawyer who’d previously
worked at the FDA. He scheduled another meeting with Elizabeth so
Kelly could hear from her directly and provide a second opinion. They
agreed to meet at 3:30 p.m. on December 9, 2011, at the Washington,
D.C., offices of Theranos’s law firm, Zuckerman Spaeder.
Elizabeth came to the meeting alone with a single-page document
outlining the same regulatory approach Shoemaker had heard her
present a few weeks before in Palo Alto. He had to give it to her: the
structure she laid out was creative. One might even call it sneaky.
The document explained that Theranos’s devices were merely
remote sample-processing units. The real work of blood analysis
would take place in the company’s lab in Palo Alto, where computers
would analyze the data the devices transmitted to it and qualified
laboratory personnel would review and interpret the results. Hence
only the Palo Alto lab needed to be certified. The devices themselves
were akin to “dumb” fax machines and exempt from regulatory
oversight.
There was a second wrinkle Shoemaker found equally hard to
swallow: Theranos maintained that the blood tests its devices
performed were laboratory-developed tests and therefore beyond the
FDA’s purview.
The Theranos position then was that a CLIA certificate for its Palo
Alto lab was sufficient for it to deploy and use its devices anywhere.
This was a clever theory, but Shoemaker didn’t buy it. And neither did
Kelly. The Theranos devices were more than just dumb fax machines.
They were blood analyzers and, like all other blood analyzers on the
market, they would eventually need to be reviewed and approved by
the FDA. Until then, Theranos would need to consult with an
institutional review board and come up with a study protocol that the
agency could live with. It was a process that typically took six to nine
months.
Elizabeth continued to disagree despite the army lawyer’s presence.
Her body language wasn’t as hostile as it had been in Palo Alto and she
was more willing to engage in a discussion, but they remained at an