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Pharmacogenomic Data and Labeling: A Less-Safe Harbor for Existing Drugs?

At the same time that FDA is taking pains to assure companies that pharmacogenomics data won't affect the review process for new drugs unless the agency and the sponsor first agree on the meaning of those data, it's also thinking of taking a tougher position with existing drugs.

At the same time that the FDA is taking pains to assure companies that pharmacogenomics data won't affect the review process for new drugs unless the agency and the sponsor first agree on the meaning of those data, it's thinking of taking a tougher position with existing drugs. The FDA is in the midst of considering the appropriate standards for reviewing labels of existing drugs to see if they should now include pharmacogenomics data that would better inform physician prescribing decisions. And the agency appears to be contemplating a threshold for review that is lower than the level of adverse event reporting that would trigger a review for the purposes of recalling a compound.

For some time, FDA officials have been ratcheting up efforts to work with industry to determine the appropriate uses for pharmacogenomic information in clinical decision making. The pace of the...

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