Medical Device Group Lays Out Innovation Agenda
AdvaMed says its plan is designed to reinvigorate an industry that's been facing tough times of late. FDA red tape and the medical device tax are chief among the things the trade group would like to eliminate.
Members of the Advanced Medical Technology Association (AdvaMed) have been smarting in the nearly five years since the Affordable Care Act was signed into law, but the group is now ready to push for policy changes to strengthen the industry.
AdvaMed has launched a new Innovation Agenda, meant to address the weaknesses facing the industry. AdvaMed President and CEO Stephen Ubl argues that overcoming the obstacles would help to create jobs and bring medical innovations to market more efficiently.
“The medical technology sector has the potential to drive the new innovation economy, developing the next generation of cures and treatments and creating well-paying jobs—the types of middle-class jobs the president and Congress want,” Ubl said in a news release last month.
The five-step agenda includes:
- A push to improve the Food and Drug Administration’s regulatory processes to shorten approval times for medical devices and diagnostics.
- Suggestions for improving the coverage and payment processes for the Centers for Medicare & Medicaid Services. The association hopes to encourage processes that support new technology development and “provide prompt patient access to these technologies.”
- A repeal of the medical-device excise tax, which the association says is “draining resources from American manufacturing jobs and research.”
- Boosting fair trade access to open up international markets to medical device makers.
- Improving the industry’s infrastructure for research and development.
Industry officials say the excise tax is especially harmful to research and development. In comments to NewsWorks, Paul Touhey, a consultant for and former president of Fujirebio Diagnostics, said the tax negatively affected the company’s innovation pipeline.
“We have not laid anyone off, or cut jobs, but we had a vision and a mission to create more cancer tests, and the way to do that is to hire more research and development employees. We haven’t been able to do that,” Touhey told the publication.
AdvaMed’s Ubl says that red tape is nearly as bad for the industry.
“Nothing could do more to stimulate investment in technologies that make a big leap forward in clinical effectiveness than the prospect of prompt FDA approval and insurance coverage,” he said at a news conference last month.