In a discussion titled “FDA, IOM and 510(k): Now What?” panelist Joshua Makower, MD captured the sentiment of many in the industry by doing the following: He first asked attendees directly involved in the device industry to raise their hands. Makower then asked those involved in the medtech sector if they had encountered frustration in dealing with FDA. Nearly everyone whose hands had been raised kept them up. Finally, he asked those from the industry if they felt FDA’s efforts to improve recently had paid off. Of the dozens of people who raised their hands in the first place, maybe one or two kept them raised at that point.
The Tenor of the Discussion
Foy said that although the agency isn't planning on throwing the 510(k) out as the Institute of Medicine advised, it is considering the remaining seven recommendations that the institute submitted. In fact, in some sense, FDA is already acting on them, Foy said. A report concerning the agency's plans regarding the 510(k) will be released "soon," Foy added.
Foy explained that, according to the agency's internal research, FDA inappropriately requested information from device firms about 8% of the time. "So based on that, we've put some additional steps into place. When we see anomalies that are happening, we are capturing that," Foy said.
She also pointed to the CDRH Center Science Council, which she says will help the agency "have active dialogue." "We needed a fresh perspective," she added.
In addition, the agency has a entrepreneur in residence program that is "really looking at the innovation pieces," Foy said. "We are trying to enact steps to ensure that there is transparency and predictability." Another major goal of the agency is to "streamline" the approval process for products that are innovative, Foy added.
An Industry Perspective
When asked for his thoughts on FDA's attempts at streamlining the approval process and fostering innovation, Makower said that he thinks it's great that the agency is trying things like this. "I think it's also great where we have come to a place that there is an acknowledgement that there are some problems. There is a concern on the impact FDA is having on innovation." [Ed note: these comments echoed something Dr. Thomas Fogarty had also said: namely, "The FDA has finally woken up and realized what is happening in the United States to the medical industrial complex."]
Makower acknowledged that FDA was working hard. The agency's efforts are well intentioned but "perhaps not on target yet," he added. "The guidance documents that came out in the summer and early fall have the right headlines, but, in the details, there are concerns about caveats that would bring us right back to where we were before," he said, adding that through the comment process, hopefully, these issues would be resolved.
He, however, didn't approve of the guidance on clinical trials.It is sort of putting a gold star on double-blind tests, which are extremely expensive and almost impossible for a manufacturer to realistically carry out, he said. "It is sort of unachievable from a financial or a practical standpoint.
As for the innovation pathway, Makower thinks "the language [describing it] sounds right" but the ideas aren't fully there yet. "I don't think [the currenty pathway] is scalable and it is expensive and will consume a lot of resources," he said. "As a way of fixing our existing problem, it's an expensive way to get there." He added that the pathway would only apply to a small number of projects and then asked "who is going to decide what's innovative or not?"
FDA should redouble its efforts on focusing on what is the most efficient and can demonstrate real returns early. "Some of these things [that are proposed] look like they won't have a benefit for a while," he said
Note: Check back soon for more from insights from the discussion.