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Jun 28, 2010
 |  BioCentury  |  Regulation

PGx: Back to the Drawing Board

FDA and Congress looking for a new regulatory pathway for pharmacogenomic tests

FDAand key members of Congress have decided the agency's current policies aren't sufficient to ensure the safety and efficacy of pharmacogenomic diagnostics, so they have launched separate efforts to expand FDA's oversight of the field.

The legislative and administrative efforts are in their early stages, which may allow test developers, clinical laboratories, drug companies pursuing products coupled with companion diagnostics, and the medical community to shape the future regulatory environment.

Stakeholders will have a chance to express their views at a public meeting FDA is hosting on July 19-20 on the oversight of laboratory-developed tests (LDTs). FDA is soliciting proposals about how it should extend its reach to actively regulate LDTs - a domain it has up to now left largely untouched.

FDA historically regulated in vitro diagnostics (IVDs) based on where the tests are developed and performed. IVDs distributed as kits are regulated as medical devices and manufacturers must demonstrate clinical safety and efficacy prior to marketing (see Online Links, A20).

In contrast, IVDs developed and used at a single site are considered LDTs, or "homebrew" tests, and are subject solely to regulation by the Centers for Medicare and Medicaid Services and the Centers for Disease Control and Prevention under the Clinical Laboratory Improvement Amendments (CLIA). CLIA requires demonstrations of analytic validity, not clinical utility.

The framework made sense when CLIA was implemented in 1988. At that time, most LDTs were simple, well-characterized diagnostics or for rare diseases for which adequate validation was not feasible, according to Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH).

"That landscape has dramatically changed over the last several years. Now we are dealing with high-risk, very complex tests being used to inform treatment management," he told BioCentury.

FDA Commissioner Margaret Hamburg and NIH Director Francis Collins made the case for FDA regulation of some LDTs in a commentary last week in...

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