Medical Device Link.

Originally Published IVD Technology January/February 2004

INDUSTRY NEWS

Richard Park

A new FDA document, "Draft Guidance for Industry: Pharmacogenomic Data Submissions," encourages drug and biologic developers to perform pharmacogenomic testing during drug development and clarifies how FDA will evaluate the resulting data.

In the draft guidance, FDA said the promise of pharmacogenomics lies in its potential ability to individualize therapy by predicting which individuals have a greater chance of benefit or risk, therefore helping to maximize the effectiveness and safety of drugs. FDA believes that pharmacogenomic testing can be smoothly integrated into drug-development processes.

The guidance also provides specific criteria and recommendations on submitting pharmacogenomic data for investigational new drug applications (INDs), new drug applications (NDAs), and biological license applications (BLAs). This includes information on what data are needed and how FDA will or will not use such data in regulatory decisions. In addition, FDA plans to issue further guidance on codeveloping pharmacogenomic tests and pharmaceuticals in the near future.

Some industry analysts believe the new guidance is a step in the right direction that will eventually benefit the IVD industry.

"FDA has taken an important step forward in defining how pharmacogenomic data can be incorporated into the development and approval process for new drugs," says Richard S. Schifreen, PhD, directory of technology and market development at Promega Corp. (Madison, WI). "This guidance will assist companies in dealing with the uncertainties inherent in this rapidly changing field. It should encourage pharmaceutical companies to make greater use of this technology, which will accelerate development of new companion diagnostic testing products."

However, other analysts are not so certain that this guidance will have such an effect on the industry.

"This process of linking new therapies and monitors has evolved over time," says Glen P. Freiberg, vice president for regulatory, quality, and government affairs at Gen-Probe Inc. (San Diego). "This process was weak in the past and remains weak for many of the therapy monitors."

Comments and suggestions regarding this draft document should be submitted to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The draft guidance can be accessed via FDA's Web site at www.fda.gov/cder/guidance/5900dft.pdf.

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