portion of his twenty-year career at the agency pondering the question
of laboratory-developed tests.
The FDA had long considered it within its power to regulate LDTs,
as laboratory-developed tests were known. However, in practice, it had
not done so because back in 1976, when the Federal Food, Drug, and
Cosmetic Act was amended to expand the agency’s authority from
drugs to medical devices, LDTs weren’t common. They were only
made by local laboratories occasionally when an unusual medical case
required it.
That changed in the 1990s when laboratories started to make more
complex tests for mass use, including genetic tests. By the FDA’s own
reckoning, scores of flawed and unreliable tests had since been
marketed for conditions ranging from whooping cough and Lyme
disease to various types of cancers, resulting in untold harm to
patients. There was a growing consensus within the agency that it
needed to start policing this part of the lab business, and the biggest
proponent of that view was Gutierrez. When he saw the email Hojvat
forwarded to him from Shoemaker, Gutierrez shook his head in
disbelief. The approach it described was exactly the type of regulatory
end run around the FDA that he wanted to put a stop to.
Gutierrez’s view that it was the FDA, not the Centers for Medicare
and Medicaid Services, that should regulate LDTs did not mean he
didn’t get along with his colleagues at CMS. To the contrary, they had a
good working relationship and often communicated across agency
lines to try to bridge the regulatory gap spawned by outdated statutes.
Gutierrez forwarded the Shoemaker email to Judith Yost and Penny
Keller, two members of CMS’s lab-oversight division, adding a note at
the top:
How about this one!!! Would CMS consider this an LDT? I
have a hard time seeing that we would exercise
enforcement discretion on this one.
Alberto