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 FDA Week, in “FDA Appears to Answer AdvaMed Concerns Over Device Tool Program.” (Read the full version – subscription required.)
Following is an excerpt:
However, one industry attorney questions why a company would make its tools publicly available to potential competitors.
“The issue is economics. These tools will cost a reasonable amount in both time and money to develop and get FDA to accept them. If a medical device manufacturer does this, and then the tool is made publicly available, basically the medical device manufacturer has helped all of its competitors at its own substantial expense. Why would a company do that? Companies that are big enough and that do clinical trials over and over again for future product development may want to qualify their tools, but FDA clearly wants to publicly disclose these tools so that their use can be maximized across the industry. That creates a tension,” Brad Thompson, attorney at Epstein, Becker & Green, told Inside Health Policy in an email. …
The move toward publishing only summary information about MDDTs was seen by Thompson as FDA walking back a previous proposal to publish more information about qualified tools. “FDA seems to have backed off its plans to publicize these tools to only publicizing summaries, and not the tools themselves, which should incentivize companies to pursue this so long as FDA truly limits what it discloses. If the agency in practice gets overzealous in its disclosures, it could hurt these companies,” Thompson said. …
Thompson says that MDDT tools would be most helpful for clinical research organizations and regulatory consultants, but predicts it will be unlikely that tools can be protected by copyright or other IP.
“By far the biggest source of these tools I would expect to be CRO’s and regulatory consultants. CRO’s and regulatory consultants can develop a tool, and so long as FDA doesn’t give that tool away, the consultant can basically say—hey come and use us for your clinical trial and regulatory needs because we have a better tool kit than anybody else. Thus the development of tools becomes frankly a business development technique for regulatory consultants—a way to differentiate their services. Or, if the tool is protectable through copyright or other intellectual property restraints, the consultant could start to license out the tool. But I would expect that to be more the exception,” Thompson said.