FDA’s Warnings Over What Genetic Testing Companies Can Report To Patients Deemed ‘Troubling’ By Industry Group
The agency has expressed worry that unsupported claims about gene-drug links could be dangerous if they spur patients to start, stop, or switch medications in inappropriate ways. But the American Clinical Laboratory Association says the warnings could stifle a burgeoning industry.
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Groups Push Back Against ‘Troubling’ FDA Crackdown On Genetic Tests
In recent weeks, the genetic testing world has been rattled by the Food and Drug Administration’s efforts to quietly pressure a number of companies to stop reporting results to patients about how their genes may interact with specific drugs. Now, increasingly, the industry is pushing back. On Wednesday, a trade group that represents clinical laboratories sent a sharply worded letter to the agency calling its enforcement actions “troubling” and “inappropriate.” The letter, from the American Clinical Laboratory Association, warned that the agency’s actions could stifle the growth of a burgeoning industry and make it harder for patients to get the right types and doses of their medications. (Robbins, 9/18)
In other news on the FDA —
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FDA To Modernize Its IT — And Make More Efficient Use Of Data
Dr. Amy Abernethy, the principal deputy commissioner at the Food and Drug Administration, is unveiling a three-point plan to radically redirect the agency’s efforts at using computer technology. At a Wednesday meeting held by Friends of Cancer Research, a patient advocacy group, Abernethy, who is also the FDA’s acting chief information officer, plans to outline how regulators can move more of their work to “the cloud” — virtual servers – and automate work that is now done by hand. This, she said, could change the way that the agency interacts with the companies it regulates. (Herper, 9/18)
