Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in InsideHealthPolicy, in “Industry Attorney Says FDA’s New Device Plan Oversteps Authority.” (Read the full version – subscription required.)
Following is an excerpt:
An industry attorney leveled a lengthy critique at FDA’s newly created Medical Device Safety Action Plan, calling different steps of the plan “extremely imperialistic,” “expansionist,” and outside of FDA’s statutory authority as a regulatory agency. The attorney took issue with both aggressive regulatory approaches outlined in the plan, as well as the incentives FDA proposed to encourage development of safer medical devices. …
FDA’s plan calls for more quickly imposing special controls on device manufacturers, a move toward active surveillance of devices, and incentives to create safer devices, but the attorney said those methods are extra-legal attempts by FDA to micromanage the device industry, which he said would disrupt the market to the harm of industry and patients.
“Frankly, this Medical Device Safety Action plan terrifies me,” said Bradley Thompson, an attorney with Epstein Becker & Green. “And I’m quite surprised that we’re not hearing a louder cry from industry.”
