Bradley Merrill Thompson Quoted in Article, “Path Opens Up for FDA Regulation of Mobile Medical Apps”Healthcare Finance News June 20, 2012
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 "Path Opens Up for FDA Regulation of Mobile Medical Apps."
Following is an excerpt:
In the rush to regulate the fast-growing industry of mobile medical apps, Congress has apparently sidestepped a potential power struggle with the Food and Drug Administration over the agency's authority to regulate them. ?...
In a May 17 letter to Sen. Tom Harkin (D-Iowa), chairman of the Committee on Health, Education, Labor and Pensions, and Sen. Michael B. Enzi (R-Wyo.), a committee member, the MRC's general counsel, Bradley Merrill Thompson, urged legislators to allow the FDA to move forward.
"(W)e recognize and call attention to the need for FDA to improve the current approach to regulation of mHealth technologies, beyond simply focusing on mobile medical applications," the letter stated. "To be sure, the MRC believes the guidance on mobile medical applications is a significant step toward the appropriate regulation of these technologies. Indeed, the guidance provides much needed clarity in some areas, limiting regulatory oversight for certain low-risk products."
"Gaps in the regulatory framework must be addressed in order to provide the predictability and robustness that investors and innovators require to further growth in an industry that promises to revolutionize healthcare in the United States. A moratorium on the publication of the guidance on mobile medical applications will only serve to delay this important, initial step toward a comprehensive regulatory scheme," said Thompson.