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, “Industry Groups Continue Fight over FDA Final Guidance.”
Following is an excerpt:
The battle between rival industry groups trying to influence the timing of the U.S. Food and Drug Administration’s release of its final guidance on mobile medical applications continues to heat up.
Nevertheless, in an email response to a query from FierceMobileHealthcare, MRC’s general counsel Bradley Merrill Thompson strongly disagreed with Haley’s arguments for delaying final FDA guidance. “It blows my mind that all of this controversy has erupted in FDA’s attempt to explain clearly and cogently what the law already requires,” Thompson wrote in his email. “These people who are opposing the guidance are in effect saying that software entrepreneurs should be kept in the dark about what the existing law requires, potentially creating the risk of criminal violations. The FDA laws are, after all, criminal statutes.”
“Why should FDA not publish this particular guidance? What harm does it do?,” asked Thompson. “It doesn’t expand regulation one iota, and indeed it seems that FDA is trying to deregulate some of what it already regulates. These people seem to have an agenda of big picture legislative change for the regulation of health IT. How exactly would FDA publishing this educational paper even hurt their efforts? It’s a free country, they can pursue whatever they want. But in the meantime, they are utterly stifling medical mobile app entrepreneurs by denying them educational materials written in a way that translates complicated legalese into simple language.”
Last month, FierceMobileHealthcare interviewed Thompson about the current regulatory environment and his work with MRC and the FDASIA sub-workgroup.