Pharmacogenomics Makes an Important Regulatory Debut
Revolutions often start small, and this one is embarking at the molecular level. Last year marked the first fledgling effort by the FDA to start gathering voluntarily submitted genomic data on new drugs. But as the agency makes clear, there will be a growing focus on finding patient subsets that benefit from a specific drug targeted to their condition. New genomic information is already being added to the labels of a handful of pioneering drugs. In the near future, that number is likely to grow exponentially--a trend no one with drugs in the pipeline can ignore.
The advantage here is that drug developers will be able to tailor drugs for specific groups, raising the likelihood of approval and making a solid case for inclusion on payers' drug formularies. The downside is that as drugs become more targeted, less waste will inevitably translate into lower revenue.
Welcome to the revolution.....
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