Bradley Merrill Thompson Quoted in Article “HIT Stakeholders Propose Modernizing, Limiting FDA Role In Oversight”FDA Week August 30, 2013
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, "HIT Stakeholders Propose Modernizing, Limiting FDA Role In Oversight."
Following is an excerpt:
A key industry attorney and Health IT Now posed differing views about FDA's role in a tri-agency regulatory strategy for health information technology, with the attorney pushing for FDA to provide clear but flexible oversight while the broad-based stakeholder group said the agency's role should be limited to medical technologies. The comments come as a federal workgroup is slated to present its final recommendations to the Office of the National Coordinator for Health Information Technology next week.
On Wednesday (Aug. 28) Bradley Merrill Thompson, an attorney with Epstein Becker & Green who is also a member of the FDASIA Workgroup, submitted a white paper to ONC that, like the workgroup's recommendations, identified several outdated aspects of FDA's regulatory framework that he said should be addressed so the agency can better regulate the unique aspects of health IT.
To develop regulations that support development and innovation, electronic health should to be protected from over-regulation, he said. For example, FDA should be mindful of the innovation process for HIT and allow for tinkering, Thompson said. He also urged FDA to understand the process for developing and manufacturing health technology is typically non-linear and said the agency should not establish regulations for quality that attempt to make development a linear process.
"Regulatory restrictions in the name of a quality system that attempt to make development a purely linear process are doomed to cause confusion and unnecessary burden," he said, adding that regulatory obligations that dramatically lengthen product life cycles would also stifle developers' ability to constantly change and progress.
Thompson also noted the need for FDA to be flexible when developing regulations focused on the intended use of the product since there are many different forms of business agreements among vendors supplying various components of technology networks and their customers that could result in a variety of uses for those components. FDA regulations will need to be flexible enough to accommodate those joint ventures. The agency's recommendations should also be clear enough to allow small companies to develop business plans that will meet regulatory demands and not delay market entry, he said.