Bradley Merrill Thompson Quoted in “CDS Coalition Petitions FDA”POLITICO Morning eHealth August 22, 2016
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO Morning eHealth, in “CDS Coalition Petitions FDA,” by Darius Tahir.
Following is an excerpt:
Prompting the agency is the CDS Coalition, which filed a citizens’ petition with the agency last week, regarding a specific category of such software: the programs that assist drug treatment. Its general counsel, Bradley Merrill Thompson of Epstein, Becker & Green, tells us that the group’s frustration stems from the agency’s propensity to give case-by-case responses rather than advance more general principles.
“Industry simply cannot go through a consultative process every time we contemplate a new product, or change direction in product development. We have to know the rules of the road,” he said.
But, he notes, traditional guidance has its own difficulties: trying to cover a broad area — like CDS — means coming up with principles that describe everything from simple stuff to complex operations. So Thompson proposes a third way: “advisory opinions,” which the agency frequently issued before the 90s.
The agency, he proposes, could issue the opinions on various case studies, and thereby help developers working in those areas, while not committing FDA to overly broad policies.