Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Top FDA Device Official Skeptical Of Breakthrough Path For Companion Dx."

Following is an excerpt:

FDA's top device official and key stakeholders are raising questions about the usefulness of a proposal to set up a breakthrough pathway specifically geared to companion diagnostics. Agency device center chief Jeff Shuren assured lawmakers last week that so far there have been no delays in FDA's approval of companion diagnostics that are tied to breakthrough drugs.

Bradley Merrill Thompson, an attorney for Epstein, Becker & Green, said he was cautious about the proposal to establish an entirely new breakthrough path for diagnostics, although it was an "intriguing" idea. FDA has typically defined a breakthrough product in such a way that it limits the scope to only a very few number of products, he said adding that most diagnostics are unlikely to qualify for a breakthrough designation.

"Breakthrough: Every time it comes up the bar gets set so high that it's only one tenth of a percent that qualifies for it," Thompson said. "In the device world advances are incremental. That's true for diagnostics too."

Further, he said, the breakthrough designation typically is not broadly valuable for industry.

Personalized medicine is one of several areas the House Energy and Commerce Committee is examining as part of its medical innovation initiative. The committee is expected to introduce legislation some time next year. 

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