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'Policy Forces' Retarding Pharmacogenomic-Backed Off-Label Rx Use

NEW YORK (GenomeWeb News) — “Policy forces” inside the US government are preventing genomic technologies from helping physicians make off-label prescribing decisions, according to a prominent US Food and Drug Administration official.
 
“Medicine is becoming more personalized as tools like genomics make it possible to tailor treatments on an individual basis,” Scott Gottlieb, deputy commissioner for medical and scientific affairs, said in a speech at Windhover's FDA/CMS Summit in Washington, DC, earlier this month.
”Physicians will not be able to always wait for FDA to approve a new label for every one of their patients, and drug companies will not be able to conduct a trial to explore every possible contingency,” he said.
 
In the future, said Gottlieb, “personalization of care could mean that we will have much more off-label use of new medicines, guided by the latest literature, at least until our regulatory approaches are able to fully adapt to a different paradigm where treatment is highly specific to individual patients.
 
“Yet policy forces are tugging in exactly the opposite direction by placing restrictions on the exchange of some of the most pertinent information,” he said.
 
A transcript of his speech can be found here.

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