Bradley Merrill Thompson Quoted in “CDRH Sets Performance Goals to Reduce Draft Guidance Ambiguity”

The Gray Sheet

Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Gray Sheet in “CDRH Sets Performance Goals to Reduce Draft Guidance Ambiguity,” by David Filmore. (Read the full version — subscription required.)

Following is an excerpt:

Bradley Merrill Thompson, an attorney with Epstein, Becker & Green who represents device, drug and health IT companies, said the creation of metrics "is a step in the right direction," but that the goals announced Jan. 8 are not aggressive enough. "Now we just need them to make bolder commitments." …

Overall, Attorney Thompson calls the reforms "incremental improvements." The Combination Products Coalition, an industry group overseen by Thompson, has been pressing for reforms to the guidance process, including in a 2012 citizen petition. Quicker resolution of draft guidances and more routine communication about guidance topics even before a draft is released are central components of the coalition's proposals, but FDA's new policies don't go far enough. Thompson says.

"We've been saying that a substantial overhaul of the guidance development process is in order," he said. "It's time to move away from a guidance development process that has fallen hopelessly behind in communicating regulatory expectations with regard to new technology.