Bradley Merrill Thompson’s Articles and Comments on Legislation and Regulatory Guidance For Mobile Health Apps Cited in Maryland Law ReviewMaryland Law Review Fall 2015
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was cited in the Maryland Law Review, in “The FDA, Congress, and Mobile Health Apps: Lessons from DSHEA and the Regulation of Dietary Supplements.” Mr. Thompson’s frequent commentary on medical device law and regulation was cited throughout the article.
Following is an excerpt:
Still, Congress continued to attempt to craft a statutory barrier to diminish FDA regulation of mobile health apps. The release of the final MMA Guidance was preceded by a bill proposed in the House of Representatives, the SOFTWARE Act of 2013,134 and followed by a similar bill in the Senate, the PROTECT Act of 2014. 135 Both bills concerned the FDA’s authority to regulate mobile health apps. Bradley Merrill Thompson, counsel for the MRC and part of the FDASIA workgroup, surmised that Congress was trying to frustrate the efforts of the FDA with these bills, particularly because the PROTECT Act was introduced so soon after the MMA Guidance and shortly before the release of the expected FDASIA Health IT Report. …