The Food and Drug Administration Tuesday proposed a new program to speed marketing approval for high-risk medical devices intended to treat patients with serious conditions that have no other treatment options.
Reuters reports the proposed Expedited Access Premarket Approval Application program would feature earlier and more frequent interactions between companies and FDA staff. The program is not a new pathway to market, the FDA told Reuters, but rather a change in approach aimed at reducing the time it takes to develop a product and get it to market.
The proposal is a response to criticisms by policymakers, patient groups and the industry that the FDA's process for approving medical devices is inefficient and slow, thereby denying patients access to new, helpful products. Several years ago, the FDA promised that more expedient reviews of medical devices would allow safe and effective devices to come to market faster and cheaper.
Minnesota is home to more than 350 medtech companies, which directly employ more than 35,000 people at medical device companies and another 250,000 in related industries.
Many in the medical device industry welcomed the FDAs recent promises to speed up the review process for new products.
“We are the Silicon Valley of the device world having the largest concentration of medtech jobs in the world right here in Minnesota,” says Mark DuVal, a regulatory attorney who helps medtech companies navigate the path through FDA. “The need to insist on improvement at FDA is vitally critical and is recognized in a bipartisan way by our Minnesota congressional delegation.”
The agency said speedier reviews should facilitate innovation, especially by start-up companies needing venture capital to fund development of new technologies, MPR News reports.
A majority of Minnesota-based CEOs and venture capitalists surveyed by the Minnesota High Tech Association mentioned FDA regulatory difficulty as a major concern.
Here are some of the survey results:
– The majority (64 percent) of leaders surveyed have an unfavorable impression of the industry, in large part because of the regulatory difficulty FDA poses. Respondents said the “unpredictable” and “unresponsive” FDA stifles their ability to innovate and be competitive because of its risk aversion and uncommonly long approval process — 28-76 months on average to clear products for market.
– Thirty-six percent of surveyed leaders said they would not invest in the medical device industry. In fact, more than half of those surveyed said their growth strategy is to focus on market releases outside of the United States — with 40% focused on Europe and 12% on developing markets.
– Eighty-five percent of the medtech leaders said the U.S. regulatory environment has negatively affected their ability to create jobs. And more than a third (35%) said future job growth for their company will occur outside of the United States.