By Brian Reid
August 13, 2003
| Hoping to give pharmacogenomics a needed boost, the FDA's new commissioner has thrown his weight behind efforts to quickly set agency policy on the matter.
"In the absence of guidance, [McClellan] feels the industry is reluctant to move forward," says Lawrence Lesko, director of the Office of Clinical Pharmacology and Biopharmaceutics at the FDA's drug branch. "This has particularly impacted my group." The FDA has faced the issue before and has approved a few drugs intended for use with specific genetic tests.
Lesko and his team are working furiously to deliver needed guidance. Their first deliverable, expected this month, will be to explain how companies can submit pharmacogenomic data to the FDA — even when that information isn't crucial to the review. If they're assured they can release those data into a "safe harbor," Lesko says, companies will be more willing to share information, and the FDA will quickly expand its currently limited access to pharmacogenomic information.
The FDA plans to follow up that guidance with a public meeting in November, co-sponsored with the Pharmaceutical Research and Manufacturers Association of America and the Biotechnology Industry Association, to discuss the best ways to make the "safe harbor" concept work.
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