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FDA Seeks Genomic Data from Drug Companies
  
By Nancy Touchette

Microarrays and other genomic data are the subjects of new FDA guidelines.

The U.S. Food and Drug Administration (FDA) would like drug makers to submit the results of genomic tests when seeking approval for new drugs. But pharmaceutical companies often don't know what kind of information to submit or whether revealing the results of genomic tests will help or hurt their chances of getting a new drug approved.

To clear up some of these questions, the FDA has issued a draft guidance for industry called “Pharmacogenomic Data Submissions,” a document with recommendations that lay out what kind of data to submit and how the agency plans to use them. The guidance is not legally binding, but drug companies are encouraged to follow it.

The guidance, published in the Federal Register on November 4, 2003, was the subject of a workshop sponsored by the FDA, in conjunction with the Drug Information Association November 13-14 in Washington, D.C. When finalized, the guidance will not be legally binding but drug companies are encouraged to follow it.

“An FDA regulation is set in stone and must be adhered to,” says Lawrence J. Lesko, Director of Clinical Pharmacology and Biopharmaceutics at FDA. “A guidance is intended to interpret the regulations. This new guidance reflects our best thinking in how we would like drug companies to deal with pharmacogenomic data.”

Pharmacogenomics is a relatively new science aimed at understanding how differences in DNA sequences might explain why individuals sometimes respond differently to the same drug. The hope is that physicians will someday be able to predict who might benefit and who could be hurt by a particular medication, based on a patient's genome sequence.

Drug companies are required by the FDA to share any test results related to a new drug's safety and efficacy. But it is not often clear how to interpret the results of genomic tests. For example, DNA chip technology, or microarray analysis, which measures the activity of thousands of genes in a given type of cell or tissue, often yields results that are not reproducible from one laboratory to the next.

The new FDA recommendations require that drug makers submit genomic data to the FDA if that information is being used to make any decisions in a clinical trial, such as what dose of drug is optimal, which patients are eligible, or whether the drug is safe or effective.

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Also, FDA requires the results of any test on what it considers a “valid biomarker”—a well-studied gene that is known to be correlated with a particular response to a drug. For example, genes that code for certain cytochrome proteins are known to affect drug metabolism and are considered valid biomarkers.

If drug manufacturers conduct tests that are more exploratory in nature on genes or sets of genes, the FDA does not require that the data be submitted, but hopes that the manufacturers will submit the test results voluntarily. Under the new guidance, most pharmacogenomic tests will not be required for new drug approval.

FDA is planning to issue additional guidances in the future that deal with genomic data. The next draft guidance, expected in 6 months, will deal with how to design studies involving pharmacogenomics. The third guidance, expected by the end of next year, will deal with genomic tests that are developed in conjunction with a new drug to evaluate who might best benefit from the treatment.

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