Lobbying the Lobbyists

This year’s NIO public policy tour [see article p7] represented a significant milestone for the neurotechnology industry, much more so than last year’s event. For one thing, this year’s tour included more representation from neurotech device manufacturers, including the big three players Medtronic, Boston Scientific, and St. Jude Medical. We understand that Elliot Krames from the International Neuromodulation Society was instrumental in arranging the participation of these three key vendors and we salute him for that.

Having the participation of so many device vendors this year meant that congressional and regulatory agency staff members obtained a clearer view of the makeup of the industry and the unique issues that affect hardware as opposed to pharmaceutical manufacturers. It also raised the level of priority within NIO to arrange a meeting with officials from the Centers for Medicare and Medicaid Services, which was not originally on the agenda—most likely because of the logistical headache that would be involved. NBR readers will recall that this editor argued strongly for including CMS on the policy tour in this space last year [NBR Apr07 p2] and then again in person at the 2007 Neurotech Leaders Forum in October.

We’re glad that this “internal” lobbying paid off because the CMS meeting was the highlight of the policy tour in the minds of many participants. Although the meeting was somewhat unwieldy with more than a dozen CMS officials in addition to the NIO delegation, it was worthwhile for these individuals to meet face to face with so many neurotech executives and it was insightful for the industry representatives to get even a vague idea how things get done at the agency. We were encouraged to hear of CMS’ openness to more interagency collaboration and town hall-style meetings with affected parties. We were a little discouraged, however, to hear CMM director Jeff Rich caution vendors against “cherry-picking” the enrolled population in a clinical trial. It is our belief that biomarkers and other selection tools that help a vendor hone in on its most appropriate target population will save the government money in the long term by allowing clinicians to choose from among several alternative therapies the one that is most effective for the patient.

In both the CMS and FDA meetings, government officials wanted to be sure that NIO was speaking on behalf of the entire industry and for this reason it will be in their interest to be as inclusive as possible in future meetings. We congratulate NIO and executive director Zack Lynch for their hard work putting together a very worthwhile and informative policy tour and look forward to participating again in the future.

James Cavuoto
Editor and Publisher