Bradley Merrill Thompson, Member of the Firm, and James A. Boiani, Senior Counsel, in the Health Care and Life Sciences practice, in the Washington, DC, office, were quoted in Law360, in “GOP Senate Will Press FDA to Ease Up,” by Jeff Overley. (Read the full version - subscription required.)

Following is an excerpt:

It's a space that is evolving rapidly, and Republicans have expressed more concern than Democrats that the FDA could stomp on next-generation products just as they begin to sprout. Even though regulators have been hands-off, many lawmakers and manufacturers are calling on Congress to say precisely what the FDA can and can't regulate.

Legislation of that sort "stands a reasonable chance" of passing in the coming year, probably with at least a bit of Democratic support, Epstein Becker Green attorney Bradley Merrill Thompson said.

The GOP's Senate takeover means "the resulting bill might push the envelope more in terms of removing specific types of health IT from regulatory oversight," Thompson added. …

James A. Boiani, senior counsel at Epstein Becker Green, predicted that Republicans won't completely block the FDA's plan to require LDT approvals, but that they may succeed in putting some limits on what the FDA can require.

“I don’t see them not letting FDA regulate LDTs ... but I could see them putting in some procedural controls,” Boiani said.

The FDA may offer olive branches in some areas to undercut support for legislation that would formally curb its powers, but experts say there will be limits to how far a Democrat-backed FDA will go.

"As long as Obama is [president], I think it’s his agency, and they’re going to be doing things his way," Boiani said.

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