Greater FDA Transparency Could Benefit Industry, Too, Trade Reps Say

Full article reprinted from "The Gray Sheet" - June 29, 2009

Despite concerns with maintaining trade secret protections, industry has much to gain from increased openness by FDA, device industry representatives said at a June 24 meeting of FDA's new Transparency Task Force. Read more...

Greater FDA Transparency Could Benefit Industry, Too, Trade Reps Say

Full article reprinted from "The Gray Sheet" - June 29, 2009

Despite concerns with maintaining trade secret protections, industry has much to gain from increased openness by FDA, device industry representatives said at a June 24 meeting of FDA's new Transparency Task Force.

FDA has been criticized for failing to warn the public in time about product safety issues, and one of the first actions by new FDA Commissioner Margaret Hamburg was to create the task force of senior FDA officials in early June ( 'The Gray Sheet' June 8, 2009).

While the group's main thrust is to find more effective ways to explain controversial FDA decisions to the public, industry reps at the recent meeting said more transparency in the agency's processes would benefit manufacturers, too.

Industry Asks For More Guidance

Medical Device Manufacturers Association President Mark Leahey said that a faster, more communicative process for developing FDA guidance documents would be helpful for industry.

"Perhaps be more specific so that the sponsors understand particular requirements that are needed for a particular product category for submission," Leahey suggested.

Andrew Emmett, Biotechnology Industry Organization director for science and regulatory affairs, agreed.

"Guidance is the heart of transparency, and it's been said that lack of guidance can be like driving down a road with no posted signs and then trying to figure out what the speed limit is by seeing who gets pulled over," Emmett said.

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