Yesterday’s public forum conducted by the Food and Drug Administration (FDA) on proposed guidance to regulate a certain category of molecular diagnostic assays drew a surprisingly large and diverse number of presentations and comments from the laboratory, biotech, and healthcare industries.

When the FDA recently released two draft guidelines, one for commercially distributed analyte specific regents (ASRs) and another for IVD multivariate index assays (IVD-MIAs), it was hoping to address criticisms and claims of confusion. These two draft guidelines were largely the results of complaints that a 1997 FDA rule that defined and classified ASRs, establishing requirements and imposing restrictions, resulted in confusion.

The primary cause of confusion regarding IVD-MIA regulation circulated around IVD-MIAs that were both developed and used by laboratories. This confusion resulted because of FDA regulation of laboratory-developed or “home brew” tests. The draft guidelines from the FDA suggest that IVD-MIAs do not fall within the definition of laboratory-developed tests.

The Office of In Vitro Diagnostic Device Evaluation (OIVD) held a public meeting yesterday, February 8, 2007, to provide a public forum during which OVID heard presentations and comments from interested stakeholders. Dark Daily received the presentation materials from Alan Mertz, President of the American Clinical Laboratory Association, who made the following recommendations to achieve the goal of the Draft Guidance:

• First, ACLA recommends that FDA issue a proposed rule to address this important subject matter through the formal notice and comment rulemaking process rather than through sub-regulatory guidance.

• Second, ACLA recommends that FDA consider proposals to narrow and clarify its definition of IVDMIAs to avoid confusion and unintended consequences.

• Third, ACLA recommends that FDA work with CMS and through HHS to address its concerns through enhancement and better enforcement of the regulations promulgated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

“We appreciate that the FDA arranged the meeting,” said Mertz. “It was clear by the number of presenters how important this issue is to all sectors of healthcare, not just labs. I was struck by the number of concerns expressed about the current draft guidance by such a diverse group of stakeholders. We hope that FDA will take these concerns into full consideration if they choose to move forward.”

The gist of both Mertz’ presentation, and a November/December 2006 article in IVD Technology was that the goal of the draft guidelines was a good one, but the guidelines fall short of what they set out to accomplish. They do not further clarify what constitutes an IVD-MIA. Furthermore, the guidelines’ solution for enforcing these new FDA rules – reliance on complaints originating within the industry- is likely to result in companies turning on each other. That is not likely to serve the public health in an efficient manner.