Consumer advocates challenged the medical device industry's calls for speedier clearance pathways at the FDA during a sometimes contentious U.S. House hearing on reauthorizing FDA user fees, arguing that device makers left device safety out of the negotiations with the FDA.
Consumer advocacy groups urged the U.S. House of Representatives to take a stronger hand in promoting safety in medical devices during a hearing today on the re-authorization of the medical device user fee act.
Industry officials and venture capitalists highlighted the role the med-tech sector plays in creating high-paying jobs and generating innovative, life-saving products. Consumer advocates were having none of that, chiding the user fee negotiations for putting safety on the back burner under pressure for faster review times.
The latest agreement between the FDA and the device industry on the third go-around for the user fee program proposes to collect $595 million over 5 years, double the amount agreed to in the previous generation of the Medical Device User Fee & Modernization Act, but some say that's not enough.
"During the course of negotiations with industry, the FDA indicated that it needed resources of between $770 million to $1.15 billion to implement the performance goals desired by industry," Lisa Swirsky, senior policy analyst at patient advocacy group Consumers Union, told members of the House Energy & Commerce Committee's Subcommittee on Health this morning. "The fees paid by medical device makers are currently so modest that even doubling of the fees is a small price to pay when considering that these devices may make companies millions to billions of dollars."
Device makers and stakeholders weren't quite so optimistic, warning the panel that America's place as the global leader in medical technology depends on maintaining a swift and effective FDA.
The FDA asks medical device manufacturers to submit documentation about controls they have in place...
Medical device and pharmaceutical companies paid out $3.5 billion to doctors and hospitals during the...
Endo International agrees to settle as many as 20,000 lawsuits filed in U.S. courts against its...
Acutus Medical secured $26.2 million in new funding for its cardiac mapping technology.