Medical Device Daily Washington Writer

WASHINGTON – Just prior to the start of this year’s annual meeting of the Advanced Medical Technology Association (AdvaMed; Washington) in Naples, Florida, the organization’s top brass laid out this year’s legislative agenda at an informal discussion held here earlier this week.

Much of the focus will center on reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA), which sunsets on Sept. 30 of next year. AdvaMed has set an aggressive timeline for coming to terms with the regulators at the FDA and lawmakers on Capitol Hill, with plans to have all stakeholders on the same page by this fall, a year before the bill’s expiration.

And with the number of new device applications continuing to climb, AdvaMed is solidly behind its reauthorization. The organization’s president and CEO, Stephen Ubl, said the industry would seek “significant performance improvements” in relation to FDA reviews, noting a push for meeting 180-day review times for breakthrough devices.

In addition, he stressed that on its second go-round, MDUFMA should focus on the quality of reviews and establish more interactions between companies that are applying for product approvals and reviewers at the agency.

Also in relation to MDUFMA, AdvaMed is pushing for user fee stability. “The amount of inflation we’ve seen on the fees is unacceptable,” said Edward Ludwig, the association’s incoming chairman and also the chairman, president and CEO of BD (Becton, Dickinson and Co.; Franklin Lakes, New Jersey).

Relative to other regulatory issues, AdvaMed is actively involved in reforming post-approval product monitoring to better evaluate safety and performance. The organization also is pushing regulators to keep pace with the industry’s rapid rate of innovation, especially as more combination products involving devices, drugs and biologics come into play.

AdvaMed also is hoping that leadership issues at the FDA settle down soon and that the agency gets a permanent commissioner, a “pressure cooker” of a job, Ubl said. Adding that “strong leadership is critical,” he said the association supports Acting Commissioner Andrew von Eschenbach, who was named the FDA’s interim leader last fall. In recent years, the agency’s top post has been a revolving door, of sorts, with three permanent or temporary commissioners in as many years.

Of course, MDUFMA and accompanying regulatory matters aren’t the only issues on AdvaMed’s plate. “The industry is facing a number of challenges on several fronts,” Ubl said. “In our view, the stakes have never been higher.”

Always of concern is reimbursement, a problem because the current system is “very event-driven,” said Arthur Collins, AdvaMed’s outgoing chairman and also the chairman and CEO of device powerhouse Medtronic (Minneapolis). “Reimbursement should tend to follow where the technology is headed.”

To that end, Ubl pointed to two bills that the organization is supporting on that front. The first would reform reimbursement rates for new clinical lab tests, such as those involving molecular diagnostics, and the second deals with health information technology and would secure reimbursement for remote patient monitoring systems.

The industry’s stance, of course, is that adoption of such new technologies will lead to broad savings for the overall healthcare system.

AdvaMed also will continue to work against proposals related to gainsharing, pay for performance and physician profiling that focus too heavily on quantitative metrics such as quick cost reductions. The organization also opposes charge compression-based payments that could stymie the use of new technologies. Underscoring these positions, Ubl said it is important for payers and lawmakers alike to see the value in quality rather than quantity.

In addition, AdvaMed plans to focus on growing international markets through several initiatives. The organization is actively involved in improving the regulatory landscape in Europe and Japan, and also will work in emerging markets such as China and India to ensure that trade issues, regulatory environments and reimbursement mechanisms are favorable for medical technology growth.

Noting that about three-quarters of AdvaMed’s members are small companies with less than $100 million in annual revenue, the organization also will be more active on issues such as capital formation and reforms to the Sarbanes-Oxley corporate governance law and the Small Business Innovation Research grant program.

“At every challenge lies opportunity,” Ubl said, and AdvaMed clearly is focused on meeting such challenges and advancing those opportunities going forward, starting with emphasis on them during the association’s annual meeting in Naples, which started with social events yesterday and continues through Saturday.

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