Personalized Medicine Will Lead To Changes In FDA Approval Process For New Medications, Von Eschenbach Says

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Public Health;  Pharma Industry / Biotech Industry;  Pharmacy / Pharmacist
Article Date: 11 Nov 2008 - 8:00 PST

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Personalized medicine -- the ability to predict how patients will react to certain medications based on their genetic profiles -- will lead to changes in clinical trials and the business model for the pharmaceutical industry, as well as the FDA approval process for new treatments, agency commissioner Andrew von Eschenbach said on Friday during a speech to business students at St. Joseph's University, the Philadelphia Inquirer reports.

According to von Eschenbach, rather than focus on the positive and negative effects of new medications, trials in the future will seek to determine how medications work in the body and in patients with certain genetic profiles. He added that more cooperation will be needed among pharmaceutical, biotechnology and medical device companies in the future as a result of personalized medicine and that FDA will have to revise the agency approval process.

Von Eschenbach said, "The transformation is not a linear extrapolation of the past. It's a metamorphosis." The "future will look no more like the past than a butterfly looks like a caterpillar," he said. "Figuring out how to overhaul the drug approval process will fall to von Eschenbach's successor, to be appointed by President-elect Barack Obama," the Inquirer reports (Hill, Philadelphia Inquirer, 11/8).

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