Comments on FDA's
companion diagnostics draft guidance boil the debate down to who will have more
control over which tests are used: companies or pathologists. If FDA requires
inclusion of specific tests on labels, drug developers likely will be in the
driver's seat. If the agency simply directs that tests provide certain kinds of
data, it will be far easier for clinical laboratories to develop competitive
tests.
When FDA issued its draft guidance
in July, it was meant to facilitate the development and approval of drugs with
companion diagnostics, as well as relieve companies of the burden of
coordinating the agency's drug and device centers (see BioCentury, July 18).