Gephardt: Spur medical innovation

Ex-U.S. House leader plugs streamlined regulations, drug review

Staff WriterJuly 1, 2010 

Former U.S. House Majority Leader Dick Gephardt brought his grass-roots effort to spur medical innovation to Raleigh on Wednesday, proposing initiatives he said could simultaneously save lives and create jobs.

The former congressman, a Democrat, said the country's leadership in developing new drugs, medical devices and other health care innovations is threatened.

"When you begin to really understand what this field means to our economy, and to our health care costs, and to our quality of life, you really begin to understand that this is a really big deal," he said. "During this two-year recession we've been in, we've lost jobs in every sector of the economy save for one: health care."

Gephardt offered a multifaceted prescription that involves revamping the nation's research-and-development infrastructure and regulatory framework.

"We need your help with Congress. We need your help with the administration," Gephardt implored the audience of about 90 industry and government officials who gathered for lunch at the Capital City Club in downtown Raleigh.

Gephardt heads the Council for American Medical Innovation, which represents groups across the biomedical spectrum. North Carolina is the third of more than 15 states he intends to visit to drum up support for ambitious measures outlined in a new report commissioned by the council.

Certainly North Carolina stands to benefit from enhancements to medical innovation.

"We have the fastest-growing biotech cluster in the country, stretching from the mountains to the coast," said Gov. Bev Perdue, who spoke before Gephardt. She noted that the state's bio sciences sector accounts for 247,000 jobs and pumps $46 billion into the economy.

The council report, based on interviews with an assortment of 72 experts, includes these recommendations:

Making the Food and Drug Administration's review process more "science-driven" and, therefore, more predictable. Today the agency is taking longer to review new drug applications and has been approving fewer new medicines in recent years.

"The lack of certainty and predictability in the review and approval process heightens risks of failure, raises the costs of development, makes the struggle to raise capital more difficult, and ultimately denies patients timely access to innovative treatments," the report states.

Strengthening private investment in startups and research and development. One way to do that would be to make the federal R&D tax credit permanent.

Narrowing the gap between breakthrough discoveries and the point at which a drug's commercial potential has been proven, known in the industry as the "valley of death." That includes increasing the budget for the National Institutes of Health and funding approaches that foster university-industry collaboration.

Increase federal support for education in the biosciences and other technology fields.

"I have read this report and, I have to tell you, the folks who did it are right on the money," said Sam Taylor, president of the N.C. Biosciences Organization, an industry trade group.

Measures not costly

Many of these measures, such as improving the FDA's review process, wouldn't require huge chunks of money, Gephardt said in an interview after his presentation.

"Having said that," he added, "I would argue that any money spent, private or public, would have enormous payoffs."

Those payoffs, according to the report, include lower overall medical costs and improved productivity and quality of life.

Meanwhile, it has been estimated that raising the R&D tax credit from 14 percent to 20 percent - which would cost the federal treasury $6 billion a year - would create 162,000 jobs and generate $17 billion in new tax revenue. or 919-829-4877

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