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

Executive Summary

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.

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Pharmacogenomics: Promises and Problems

So far, pharmacogenomics, the study of the effects of an individual's genetic makeup on their response to drugs, has not produced the hoped-for revolution in the pharmaceutical industry, due primarily to lagging approvals and the high cost of molecular testing. Nevertheless, the promise of personalized medicine is very real, and several exciting products have received FDA approval.

The Personalized Medicine Opportunity

Personalized medicine is a field as vast as the differences between individuals, and encompasses technologies, markets, and treatment strategies ranging from autologous cancer vaccines to molecular diagnostics and gene-targeted drugs to methods for visualizing subtle differences in tissues--the foci of the three companies profiled herein.

Shaking Up the FDA

To improve regulatory predictability, Mark McClellan has plans to reduce multiple-cycle reviews. In addition, he is in the midst of adopting best review practices and developing clearer guidances in therapeutic areas where progress has been slow and in certain emerging areas. While such plans potentially offer good news for the brand-name drug companies--though the benefits will be slow to accrue since the regulatory efficiencies will take years to fully materialize--they won't lower overall system costs since lower development expenses won't necessarily lead to lower average prices. Thus the FDA is focusing on two areas in which it has direct influence on drug costs and reimbursement: speeding the approval of generics and forcing OTC switches. McClellan's desire to impose a cost-benefit mindset on the agency attempts to balance the needs of the drug industry with the needs of reimbursers, particularly the Federal government as it prepares to shoulder the new burden of Medicare outpatient drug costs.

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