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FDA’s Gottlieb: Submit Array, PGx Data - Let’s Work Together

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Depending on how you look at it, Scott Gottlieb’s career path could be a cautionary lesson or an encouragement to the squeaky-wheel community. Now the senior advisor for medical technologies in the commissioner’s office of the FDA, Gottlieb started out on the opposite side of the fence: a physician whose voice was frequently heard questioning the agency.

“I was writing a lot of articles about the FDA, some of which were critical,” says Gottlieb, 30, who was previously editor of the Gilder Biotech Report and a columnist for the American Medical Association’s weekly newspaper. So when Mark McClellan, newly installed FDA commish, asked Gottlieb to come aboard early this year, “it was sort of something [I] couldn’t say no to. … I had to put my money where my mouth was,” Gottlieb says.

He spends most of his time working on policy issues, and also helps with FDA outreach programs and writing speeches that are particularly technical. Much of the policy matters involve trying to clarify existing regulations or work on new ones that promote faster approval time and more innovative research.

With pharmacogenomics and microarrays, for instance, Gottlieb says that pharmas should take advantage of entering data from this type of work under research exemption rules. “Under certain circumstances, [pharmas] can provide us with pharmacogenomics data that we won’t consider in the approval process,” he explains. While no regulations govern that particular data yet, “the sentiment inside the FDA is that they want to see experimental data,” Gottlieb says, acknowledging that pharmas are often reluctant to submit new kinds of data for fear that it will cause problems in getting approved. “These things are early, they’re not well validated, but if we don’t see it we’re never going to learn it,” he says.

Initial guidelines for microarray experiments were expected out in August, but Gottlieb emphasizes that whatever final regulations come out, “there’s going to be a lot of opportunity for industry participants to be involved” in hashing them out. The moral: now’s the time for genomics companies and pharmas with genomics programs to communicate with the FDA about how best to consider data from arrays and other novel sources.

These guidelines will certainly be important. Gottlieb, who keeps his hand in medicine by working in the hospital intensive care unit on weekends, says the new discipline is already making its mark at the FDA: “We’re seeing more drugs coming out of genomic research programs in our early pipeline.”