excellent post, stockholder... it's happening
"It would be irresponsible and potentially harmful to suggest that testing be used, or even mentioned, in the label," said University of Washington professor Ann Wittkowsky in an interview before the FDA's decision. "It is fascinating science, but it is not yet ready for prime time."
Larry Lesko, director of the clinical pharmacology office at the FDA, says the agency has "substantial" evidence to support the new label and hopes it will improve safety by informing doctors.
Dr. Lesko is part of a larger initiative at the FDA to promote the use of genetic factors to predict how individuals will react to medicines. It's a shift for the agency, which traditionally has more of a reactive role as the regulator of the drug industry. "If the potential wasn't huge, we wouldn't be doing it," he says. "We felt we had to be more outspoken."
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