Modulating the FDA

As it was at previous events, the tardiness with which the FDA approves new devices was a major topic at this year’s Neurotech Leaders Forum [see Conference Report, p7]. One potential pathway around this problem that came up this year is marketing neurotech devices to consumer and alternative markets so that FDA approval is not necessary. For example, Magneceutical Health, which markets low-power magnetic stimulation systems for “well being” applications, said it does not need FDA approval since the company is not making a medical claim.

Another prospect for relief is a bill introduced in the U.S. Senate by Senators Amy Klobuchar (D-MN), Richard Burr (R-NC), and Michael Bennet (D-CO). The Medical Device Regulatory Improvement Act would help streamline the FDA’s regulation of medical devices to continue to spur innovation and help get new, lifesaving products to the market quicker without compromising consumer safety.

The legislation would streamline the FDA’s regulation of medical devices by clarifying least burdensome requirements. Because current conflicts of interest restrictions are overly stringent, the FDA is having difficulty finding qualified experts to serve on advisory committees. In response to this problem, the legislation would restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government. Finally, the legislation would direct the FDA to contract with an outside entity to conduct a thorough review of the management and regulatory processes at the Center for Devices and Radiological Health, including the impact on medical device innovation.

In the long run, we think a better approach is for the U.S. to take a cue from Europe and base approval of medical devices on safety alone. The decision on efficacy would be left with Medicare and other insurers. This would not only streamline the introduction of new products and save taxpayers and device purchasers money, it would also introduce some much-needed competition in the health insurance market by allowing private insurers or state exchanges to reimburse for new devices that will save them and their payees money in the long term compared to current medical procedures. Perhaps early adopters could lock in favorable pricing by taking a risk with a new therapy. Startup manufacturers would then be able to phase in new product introductions, instead of enduring years with no revenues.

Whatever the fix, it’s clear that the neurotech device industry needs changes to the current regulatory environment at FDA. It’s in all vendors’ interest to keep abreast of new legislation and to stay in touch with their elected representatives.

James Cavuoto
Editor and Publisher