Neurotech Executives Descend on Washington for NIO Public Policy Tour

by James Cavuoto, editor

Nearly 40 executives from neuro­technology companies and organizations came to Washington, DC earlier this month for the 2008 Public Policy Tour sponsored by the Neurotechnology Industry Organization. The second annual event enabled representatives from the neurotech industry to interact with legislators and regulators and gain a better understanding of how decisions are made in the nation’s capital.

After a briefing by representatives of the lobbying firm K&L Gates, participants headed to Capitol Hill for meetings with congressional staffers, and in some cases, members of Congress themselves. NIO encouraged participants to push legislators to support a newly drafted National Neurotechnology Initiative (NNTI), which would authorize about $200 million in new funding for neurotech-related projects.

Rep. Patrick Kennedy (D-RI) announced he would introduce the legislation in the House on March 12, and Sen. Pete Domenici (R-NM) was expected to introduce it in the Senate. “The current mousetrap of federal initiatives isn’t working, and needs to be changed,” Kennedy said in a press conference. “We’ve worked on a bipartisan basis to help make federal research much more effective, to make sure the right hand knows what the left hand is doing.”

Kennedy pointed to Neurotech Network executive director Jennifer French as an example of what can be accomplished. French, who suffered a spinal cord injury several years ago, was one of the first users to be implanted with a functional electrical stimulation system that lets her stand up out of her wheelchair. “Her experience is an example of how this technology can be applied to others,” he said. In response to a question from NBR concerning the Centers for Medicare and Medicaid Services’ refusal to reimburse for FES systems such as French’s, Kennedy reacted strongly, contending that people with disabilities have a constitutional right to treatments such as this. “The next administration will need to make a lot of changes with CMS,” he said.

On the second day of the tour, participants met with representatives from the CMS and the Food and Drug Administration. Among the CMS personnel in the meeting were Barry Straube, director of the Office of Clinical Standards and Quality, and Jeffrey Rich, director of the Center for Medicare Management. Rich advised participants to design clinical trials broadly, and include cost components. Straube stressed the agency’s renewed reliance on evidence-based medicine for national coverage decisions. The CMS representatives seemed to welcome input from the neurotech community with regard to “horizon scanning” and interagency collaboration.

FDA representatives spoke of the agency’s new critical path initiative, which involves patients, industry, caregivers, and researchers. The representatives seemed open to input from neurotech executives but cautioned that there wouldn’t be time for multiple meetings. They cited as a positive example a recent orthopedic device forum as an effort to help train CDRH staff. They suggested it might be acceptable for the neurotech industry to propose a draft guidance document that might indicate acceptable endpoints.

For the most part congressional staffers seemed to express interest in the NNTI, though there was private speculation that it might be difficult to secure funding on the first attempt. There is currently considerable sensitivity on the hill to servicemen and women returning from Iraq with brain injuries and post-traumatic stress disorders and several members are concerned that there might be an underestimation of the number of cases of TBI. Many of the staffers met with during the two days were not aware of the neurotechnology industry and appreciated the opportunity to meet directly with executives.

The $200 million sought for the NNTI is a scaleback from last year’s first cut at the initiative. Among the key components are $5 million for the establishment of a coordinating office within the Department of Health and Human Services to serve as the unified voice of federal neurotech efforts; $80 million to authorize the NIH Blueprint for Neuroscience Research, a collaboration between the 16 NIH institutes involved in brain and nervous system research; $75 million to increase NIH funding for SBIR and STTR programs, with an emphasis on translational neurotechnologies; $30 million to increase neuroscience-related staffing and training at the FDA; and $10 million to establish a research center to conduct studies on the ethical, legal, and social implications of neurotechnology.

Neurotech device-oriented organizations participating in the two-day event included Cyberkinetics, Boston Scientific, Medtronic, Advanced Neuromodulation Systems, Neurotech Network, PhotoThera, International Neuromodulation Society, and NeuroNexus Technologies. Neuropharma firms Accera, Adlyfe, Pfizer, Alseres, and Sound Pharmaceuticals also participated.