By Kirell Lakhman

CDRH’s 2010 budget could hurt the ability of high-complexity labs to perform the kinds of genomic tests that are already a critical linchpin of clinical pharmacogenomic testing.

While med and molecular techs tend not to pay too much attention to federal lawmaking in general, and in particular the high-altitude waltzes that yield policy and spending plans.

But at least one budget that has recently passed in the House could directly affect how translational labs within or without clinical labs develop genomic tests, and could potentially slow the pace at which these tests are adopted and, eventually prescribed by hospital docs.

I’m talking about a bill the House overwhelmingly approved July 9 that would give FDA $2.99 billion for its operations in 2010, which amounts to a $373 million improvement of 2009 — an in crease the Wall Street Journal has called “the largest boost in the agency's history.”

(The FDA budget has been passed by a Senate committee but has yet to be voted by the full chamber.)

As part of that $2.99 billion package, CDRH, the arm responsible for in vitro and other molecular diagnostics, including some genome assays, would receive $349 million in 2010, or 13.7 percent more than the $307.2 million it received in 2009, according to the Journal article.

Now, iIt’s been widely reported that CDRH’s Office of In Vitro Diagnostic Device Evaluation and Safety intends to take a more active role in the evaluation and regulation of personalized medicine products, according to the its acting director, Don St. Pierre.

Indeed, OIVD recently received funding to help it hire 10 additional staffers whose principal aim will be to focus on personalized medicine issues.

But some OIVD experts are cautious that OIVD’s share of CDRH’s budget increase — a figure that has not been disclosed — may not be enough to fulfill its goals, which could then stifle new development and clearance of new genomic assays, and make life difficult for CLIA labs performing existing genomics tests.

The ability of OIVD’s budget fulfill St. Pierre’s promise will rest on the “extent to which OIVD chooses to expand the scope of products that it regulates,” according to Jeff Gibbs, a director at the law firm Hyman, Phelps & McNamara, and an expert OIVD watcher.

“If OIVD seeks to regulate a large segment of the molecular diagnostic laboratory-developed tests, or increase its regulation of direct access testing or otherwise expand its regulatory scope, then hiring 10 additional employees will probably be insufficient,” Gibbs told me this week.

Not only that, that FDA’s going promise to finalize its IVDMIA guidance document “could itself lead to an influx of complex submissions, with a commensurate need for FDA reviewers, and that is only a subset of LDTs,” he added.

To be sure, OIVD will have “multiple challenges” waiting them in 2010, Gibbs says: “One is determining how to regulate personalized medicine diagnostics,” which he says “will require greater clarity from OIVD as to what are the data requirements for these kinds of products.”

Another “major challenge” will be “providing greater predictability during the review process,” he said. For instance, “as device companies submit more applications for companion diagnostics, it will be critical to have clearer procedures for how these drug-device applications are to be handled and what data must be submitted,” Gibbs says.

Lastly, and more generally, “it will be important for OIVD to strike the appropriate balance between requiring sufficient data to support product clearances and approvals, without deterring innovation,” he says.