An advocacy group headed by former U.S. House Majority Leader Dick Gephardt is launching a coordinated lobbying effort to improve federal policies impacting medical innovation, including calls to strengthen the R&D tax credit and make FDA oversight more predictable.
Gephardt-Led Group Steps Up Medical Innovation Lobbying Effort
Article preview from "The Gray Sheet"- June 14, 2010
An advocacy group headed by former U.S. House Majority Leader Dick Gephardt is launching a coordinated lobbying effort to improve federal policies impacting medical innovation, including calls to strengthen the R&D tax credit and make FDA oversight more predictable.
The Council for American Medical Innovation (CAMI) issued a broad-level report on June 10 highlighting a perceived breakdown in the process for translating early-stage discoveries into marketed treatments and technologies in the U.S.
"We are going to be meeting with members of Congress, the administration, state and regional officials over the next days to highlight specific steps that must be taken in the near term to ensure that medical innovation is a cornerstone of our [economic] recovery," said Gephardt, who chairs CAMI, during a press call announcing the report. The Missouri Democrat left Congress in 2005.
CAMI's organization partners include AdvaMed, drug industry associations, physician and hospital groups, and patient advocacy organizations.
The council's agenda is centered around four basic themes: improving regulatory policy; bridging the translational research gap between discovery and delivery of new medical technologies; improving private investment in medical innovation with better tax incentives; and increasing support for U.S. math and science education.
In particular, the group is advocating for increased funds for FDA and the launch of a new public-private partnership to accelerate FDA's recently announced "regulatory science" initiative, in coordination with the National Institutes of Health, to improve the tools and methods available for evaluating new technologies.
CAMI will press for increased funding for NIH emphasizing translational research, and enhancements in the U.S. academic-to-industry technology transfer process.
Also on the council's translational research agenda is reforming the federal Small Business Innovation Research program, including a top device sector priority to allow start-ups that are majority-owned by venture capital firms access to SBIR grants.
Making the federal R&D tax credit permanent, rather than having to depend on Congress to reauthorize it every few years, is the group's top lobbying focus for increasing private investment in medical product development. It also wants to increase the size of the credit.
Over the longer term, CAMI will push for additional tax credits for manufacturing and "angel" investing, among other areas.
"Nowhere is there a better opportunity to drive new jobs than through medical research and innovation," Gephardt said.
The extra money in the federal budget that would be required to accomplish the CAMI initiatives "is pennies on the dollar in terms of what it will yield in economic growth and what it will yield in terms of health cost savings," he asserted.
Federal Innovation Office Sought
Few of the council's individual proposals are particularly novel, but the effort brings potentially disparate initiatives together under one "medical innovation" umbrella and puts more lobbying heft behind it.
To tie the policy objectives together, a new federal office will need to be established, Gephardt stressed.
"We feel we need responsibility ... somewhere in the executive branch to move this agenda forward, to coordinate it, and to collaborate with different groups in and out of the government," he said.
The former congressman said he is still in discussions with administration officials and lawmakers about where in the executive branch such an office would be most appropriately placed.
AdvaMed's Senior Executive VP David Nexon forwarded a similar proposal in May 21 testimony before the President's Council of Advisors on Science and Technology for a White House-based office to "advocate for innovation."
Nexon also suggested adding a requirement for government regulations to include an innovation-impact statement, analogous to the current requirement for an environmental impact statement.
"Requiring that a statement of this kind be included would assure that the issue of innovation is at least considered as policies are developed," Nexon said.
Device Regulatory Reforms On Radar
The most explicit reference to medical device innovation challenges in the CAMI report, prepared by research firm Battelle, is a discussion of the upcoming reforms to the 510(k) process and allusions to industry complaints that PMA reviews are taking too long.
"We think any new regulatory requirements should balance FDA's dual mission of protecting the public health, but also facilitating innovation," said Steve Ubl, president and CEO of AdvaMed, during a June 9 conference call.
That call was held to highlight the specific contributions of the U.S. medical device industry to the economy, as tabulated by a just-released Lewin Group 4 report, funded by AdvaMed.
Among the report's data points: the medical technology industry was responsible in 2008 for about 423,000 jobs and $24.6 billion in annual payroll; the industry paid salaries 40% above the national average; and each medical technology job generates an additional 1.5 jobs.
"The report paints an impressive picture," Ubl said. "However, our world leadership cannot be guaranteed in the future."
Ubl highlighted "three trends that give me pause."
He pointed to a declining U.S. trade surplus, to which the net-export device sector has historically been an important contributor; reduced venture capital investment in the industry; and FDA's failure to meet all of its PMA user fee performance goals, which, he suggests, is contributing to manufacturers placing more emphasis on Europe and other locales for "breakthrough" products.
- David Filmore
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