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 “Groups Divided Over Whether FDA Should Delay Final Mobile Medical Apps Guidance.”
Following is an excerpt:
A July 29 letter signed by 15 health care organizations is the latest to federal regulators asking for a pause in issuing any guidance or policies affecting oversight of health information technologies until after a federal task force makes its final recommendations on a risk-based regulatory framework for health technologies.
The letter from The Global Genes Project, an advocacy group for patients with rare and genetic diseases, called on leaders at the Department of Health and Human Services, Federal Communications Commission, Food and Drug Administration, and the Office of the National Coordinator for Health IT to use recommendations from the FDA Safety Innovation Act workgroup to shape any future health IT regulatory policies. The letter appears to be aimed largely at long-awaited final guidance from FDA on how it will oversee mobile medical applications.
A coalition of 132 organizations—including McKesson Corp. and standards-setting group Health Level 7 International—sent a nearly identical letter to agency leaders in June.
In comments to BNA Aug. 1, attorney Bradley Merrill Thompson with Epstein Becker & Green PC and general counsel to the mHealth Regulatory Coalition, said that although a vast majority of apps would not be regulated by FDA, many developers are waiting to go to market with products until the guidance is released.
“[M]any companies are sitting on the sidelines concerning higher risk apps that may or may not be FDA regulated,” Thompson told BNA. “Further, I believe that the developers of certain apps that clearly will be FDA regulated are also on the sidelines because they fear that until the guidance is out, other developers will blithely ignore the FDA requirements and go directly to market with cheaper, probably less effective apps that undercut the market.”
In its position paper, the mHealth Regulatory Coalition said releasing the final apps guidance would not overlap with work being done by the FDASIA workgroup and could delay the very innovation some groups hope to protect.
Thompson would not speculate on when the final FDA guidance would be released, but said the agency has indicated the guidance is going through the usual channels of approval prior to formal publication.
Likewise, he said he would not guess the motivations for some groups’ call for the guidance delay, but said he believes some requests for delaying publication of the final guidance are due to “misinformation.”
“There is some false information floating around out there regarding the extent of FDA’s existing authority, and the FDA’s intentions,” Thompson said. “I believe some people are fanning the flames arguing that FDA has some sort of expansionist agenda here. Actually, the exact opposite is true, FDA is trying to reduce its own oversight of this area.”
He said other organizations may be seeking a delay to pursue entirely different regulatory approaches to health IT and to allow time for the possibility of legislative changes.
“[T]hey want the existing FDA regulatory apparatus to stand still,” Thompson said. “The problem is, that also would mean that technological progress in this area would likewise need to stand still while this bigger legislative debate goes on. Down here in the trenches, many of us value the clarity we need to keep the mHealth revolution moving forward even while others prefer to talk about a sweeping new legislatively established regulatory process and engage in political maneuvering.”