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New FDA Guidance Will Make Genetic Data More Prominent in Drug Labels

WASHINGTON, DC – The US Food and Drug Administration wants to see genomic information front and center in a drug’s label.
The agency is poised to release guidelines for the “Clinical Pharmacology Section of Labeling for New Prescription Drugs, Content and Format,” Lawrence Lesko, director of FDA’s Office of Clinical Pharmacology and Biopharmaceutics, said at a pharmacogenetics conference held here this week by the American College of Clinical Pharmacology.
The format for new drug labels will include a pharmacogenomics section, and will relocate pertinent genetic information to a box at the top of the label.
The box “will tell you everything a doctor needs to know before prescribing a drug,” Lesko said. “One would expect, when we have the case, to see genomic data at the top of a label for a new drug. So I think we are staged to really take advantage of this information when it’s appropriate.”
With a pharmacogenomics section in new labels, FDA is “planning ahead,” Lesko said. “We’ll at least be able to begin to establish a beachhead in the label that is specifically intended for pharmacogenomic information that comes out of drug development or that comes out of post-marketing studies.”
“If this information is important enough, in the new FDA label, it moves to the top of the label where the important stuff is for prescribers,” Lesko said. “That’s a continuation of our attempt to get patients and prescribers to focus on what I feel is very important information.”
According to an FDA spokesperson, the Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products-Content and Format guidance “is being reviewed now for posting and clearance. It will be a draft guidance for comment.”
Historically, genomics information was part of a drug’s pharmacokinetic and pharmacodynamic profile and appeared in the pharmacology section, which was situated in the bowels of lengthy and text-heavy product labels.
“If you took each section of a label and ranked it, what do physicians read first or most, clinical pharmacology is not at the top of the list,” Lesko said. “I think it’s actually at the bottom of the list, right before ‘overdose’ and ‘toxicology’ information.
He said the agency wants to “improve over time where [clinically relevant genetic] information appears in the label.”

The complete version of this article appears in this week's Pharmacogenomics Reporter, a GenomeWeb News sister publication.

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