Hearing Explores Incentives for Devices to Treat Rare Conditions

Because small patient populations with rare conditions are a challenge for medical device firms to tackle given the cost of research and development and clinical trials, government incentives are needed to make the process easier, according to industry officials and lawmakers.

The topic was explored by the Senate’s Health Education Labor and Pensions Committee during a hearing on July 14 on Capitol Hill.

“I’m concerned that we still don’t have equivalent incentives for devices as we have for drugs,” Sen. Al Franken (D-Minn.) said in opening remarks. The hearing was called to discuss 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.”

The Advanced Medical Technology Association (AdvaMed), offered its perspective to committee lawmakers.

“We must create a regulatory environment where innovation to address these unmet needs can thrive,” said Stephen Ub, president of the industry trade groupl. He suggested that the U.S. 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 added. “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.”