Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Digital Health Legal, in “The FDA’s Proposed Rule on E-Labeling Raises Serious Concerns.”

Following is an excerpt:

“I largely share AdvaMed’s concerns,” comments Bradley Merrill Thompson, Member at Epstein Becker Green. “It seems to me that the FDA’s proposed rule suffers from at least three key weaknesses: 1) The FDA fails to make its case. The agency does not present data suggesting that any significant number of people are injured due to a lack of labeling for home-use medical devices. When companies go to FDA seeking product approvals, the agency is very much a data driven organisation. I find it troublesome when it doesn’t impose that same standard on its policymaking. The FDA really needs to do an analysis of adverse events to see if there’s any reliable evidence to support their case that there is a problem. 2) The FDA again largely asserts that they don’t think manufacturers are providing enough electronic labeling for home-use products. But again, the agency points to no data. 3) The FDA’s solution seems rather odd. The problem, the agency asserts, is companies not providing electronic labeling to home-use customers. Rather than tackling that perceived problem directly by requiring manufacturers to provide more labeling to customers, the FDA instead proposes to take over that function and do it for the manufacturers, albeit obviously with the manufacturers supplying the information. That is counterintuitive. Substituting a government bureaucratic solution for a marketplace solution that would cost the FDA a tremendous amount of money does not seem like a well thought out approach.”

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