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 “mHealth Regulatory Coalition Urges FDA to Release Final Apps Guidance.”
Following is an excerpt:
The mHealth Regulatory Coalition (MRC) on June 21 sent a letter to Department of Health and Human Services (HHS) Secretary Kathleen Sebelius urging HHS, through the U.S. Food and Drug Administration (FDA), to publish the final guidance on mobile medical applications (MMA) “as soon as reasonably possible.”
“The timely release of the final guidance will benefit industry, stimulate investment, help ensure patient safety and is consistent with the views expressed by Congress and the desires of the broader mHealth community,” states the letter to Sebelius from Bradley Merrill Thompson, who serves as MRC’s general counsel and whose Washington-based law firm, Epstein Becker & Green, assists with the development of the organization’s policy and government relation strategies.
In March, Thompson similarly testified on behalf of MRC in front of the House Energy and Commerce Subcommittee on Technology and Communications, calling for the FDA to release its final guidance as soon as possible. Since then, he argues that MRC has “come to learn that some people mistakenly believe that the final guidance will expand FDA jurisdiction.” In fact, Thompson says in his letter to Sebelius that “the final guidance, if it is even close to the draft guidance, will be de-regulatory in nature.”
“Many investors and companies are reluctant to invest significant time and money in mHealth technologies until the regulatory framework is clear,” he states in his letter to HHS. All the more reason that MRC believes “this level of detail is needed by industry” from the FDA’s final MMA guidance, which the organization says will “help unlock investment in the mHealth market.”