Stumbling down the path

Through its Critical Path initiative and statements on drug safety, FDA has portrayed itself as an enthusiastic supporter of personalized medicine. However, the agency has stumbled the first time the regulatory rubber hit the road, releasing a draft guidance on laboratory-developed tests that industry, patient and medical groups contend constitutes a roadblock to innovation.

These groups got a chance last week to vent their frustrations at a public meeting convened by the FDA. But it remains to be seen how the agency will address their concerns.

The draft guidance on in vitro diagnostic multivariate assays (IVDMIAs), released in September 2006, erased nearly 20 years of clearly delineated regulatory boundaries. The agency’s decision to regulate some tests that are developed and provided solely as a service by a single laboratory ("home brews") signaled the end of the old order, in which commercial diagnostic reagents and kits were subject to FDA oversight, while home brews were regulated only by CMS under the Clinical Laboratory Improvement Amendments (CLIA) enacted in 1988.

FDA’s slim guidance document - four and a half pages, including headlines and boilerplate disclaimers - has created massive confusion because it fails to explain why the agency has decided to regulate home brews, which home brew tests will be subject to premarket review, what level of review will be required for different kinds of tests, or what kinds of data will be required to obtain marketing approvals.

The agency also has not described whether or how it intends to address the need of home brew providers to modify their tests to reflect rapidly changing science and medical practice. Nor has it explained how it expects diagnostic service providers to reconcile mutually exclusive legal requirements in FDA’s medical device regulations and CLIA.

The result is a cloud of uncertainty over the molecular diagnostics sector. Companies have reported that investors have walked away from commitments, and that if FDA proceeds on the course outlined in the draft guidance, the increased regulatory cost will force them to pare back development programs.

Passive but empowered

While companies that developed home brew diagnostics in the belief that they would not be regulated as medical devices point to 20 years of precedent as well as more recent written guidance from FDA, the agency has consistently said that it has authority to regulate home brews but has chosen not to exercise it.

In rules published in 1997,

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