By Julian Pecquet - 07/21/10 03:26 PM EDT
Sen. Al Franken (D-Minn.) on Wednesday called on Congress to create extra incentives for medical device makers to tackle rare diseases.
“I’m concerned that we still don’t have equivalent incentives for devices as we have for drugs,” Franken said in opening remarks at a Senate health committee hearing on ways to promote new treatments and cures for rare and neglected pediatric diseases. “I think we can do more and I look forward to exploring this issue with the panel.”
Minnesota is home to several medical device giants, such as Medtronic.
Such companies say they need government help to make their investments in rare diseases worthwhile, because the affected populations are too tiny for them to turn a profit.
The industry group Advanced Medical Technology Association (AdvaMed) weighed in with its own set of proposals as the hearing got under way.
“We must create a regulatory environment where innovation to address these unmet needs can thrive,” President and CEO Stephen Ubl said in a statement.
Ubl suggested the Food and Drug Administration start by developing general guidance for its humanitarian device exemption (HDE) program outlining appropriate types and levels of data necessary for approval.
The HDE program exempts devices that treat or diagnose diseases and conditions affecting fewer than 4,000 people in the United States from having to scientifically prove that they are effective for their intended purpose.
“Medical technology companies also face potentially enormous (research and development) costs in developing new pediatric devices with little hope of recouping their investment due to the small market for some products,” Ubl said. “To help mitigate these costs, AdvaMed proposes Congress create a strong pediatric device R&D tax credit program as well as a tax credit for pediatric HDEs similar to the tax credit that currently exists for orphan drugs.”