Impacting the Government

Dealing with the government has always been one of the greatest challenges facing the neurotechnology industry. Whether waiting to get a new device approved by the FDA or jumping through hoops to get reimbursement by the Centers for Medicare and Medicaid Services, neurotech device firms frequently find themselves at the mercy of some government entity at every stage of the commercialization process.

Fortunately, there are signs that the situation is improving. As we point out in our conference report on page 7 of this issue, Mark McClellan, former head of both the FDA and CMS, was generally upbeat on some of the trends affecting these two agencies. He praised Congress and the administration for passing the FDA Amendment Act of 2007, which reauthorizes FDA funding and user fees for the FDA. He pointed to FDA’s commitment to more review milestones, support for critical path initiatives to streamline product approval cycles, and the government’s endorsement of Bayesian statistical models.

We’re also encouraged by the activity of nonprofit organizations active in our industry. Neurotech Network’s new Public Awareness Campaign, which they intend to announce this month [see article, p5], specifically targets the challenges of neurotech device reimbursement and market access. Executive director Jennifer French believes that the key to addressing these two issues is increasing public awareness and understanding of neurotechnology device therapies. As more users and potential users of neurotech therapies become aware that there are viable alternatives to pharmaceuticals, they will exert more pressure on clinicians, regulators, and insurers to ease some of the pain associated with getting access to these devices.

We believe that Neurotech Network’s PR activity will mesh nicely with the Neurotechnology Industry Organization’s public policy campaign [NBR Apr07 p7], which brings neurotech executives to Washington to interact with Congress and federal agencies. We also recognize the valuable lobbying efforts of the Medical Device Manufacturers Association and the more clinically oriented National Task Force on Consumer Access to Emerging Neurotechnologies [NBR Jul07 p1].

Still, despite these positive efforts, it is in the interest of all neurotechnology vendors to maintain a proactive stance with government entities. McClellan recommends that device company executives meet early on in a product’s life cycle with representatives from both CMS and FDA. He believes, as we do, that we’re still only scratching the surface of the potential health impact of technologies. The combination of a more responsive federal government and a more alert private sector can only bring good things to our industry.

James Cavuoto
Editor and Publisher



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