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October 27, 2011

Medical Groups and Venture Capitalists at War with FDA and Each Other

If there’s one thing medical device manufacturers feel they don’t need, it’s more regulation. But healthcare providers and maybe even the FDA think what they might need is even more.

It’s all coming to a head because venture capitalists are now in the mix and they want the FDA – which has been approached about intensifying current regulations after several medical boards  this summer said that not enough research is being done before these devices are approved – to step back, according to a story by Barry Meier and Janet Roberts at

The National Academy of Sciences and the Institute of Medicine released a report in July that said there currently is so little regulation of medical devices that patients could, and were being, harmed. 

The report, which was actually commissioned by the FDA back in 2009, recommended that medical devices such as artificial joints and pacemakers go through a more rigorous approval process before coming to market, according to

Consumer advocacy groups have also been critical of FDA oversight of medical devices, arguing that they typically have been cleared too quickly, according to the Web site.

“FDA's oversight and review process is too weak and needs to be strengthened,” Dr. Michael Carome, deputy director of Public Citizen's Health Research Group, told writers at in an interview at the time.

The FDA was completely blindsided by the report – and the outrage it fanned, according to a New York Times story by Meier in July.

But as we all know, money talks.

Much of the controversy surrounds the all-metal artificial hip implants that have failed at an alarming rate,  Meier and Roberts note in their story 

But the ground is shifting as venture capitalists ,” a rich and influential ally of device companies eager to remove what they say are regulatory roadblocks in the approval process,” enter the fray, write Meier and Roberts.

“They have this unwritten assumption that every new device is innovative,” Dr. Rita Redberg, who is the editor of the Archives of Internal Medicine, was quoted as saying in Meier and Roberts’ story, referring to the venture capital funds. But some devices, she said, “are killing people or causing significant harm,” she added.

Big money is involved. According to Meier and Roberts’ story, “people associated with funds that underwrite companies developing new devices and other health products have made more than $3.3 million in political donations to Republicans, Democrats and political action committees over the past five years, according to an analysis of federal contributions by The New York Times.”

Though such people donate for many reasons, they add, “about 20 percent of the money from the 182 donors identified by The Times went directly to candidates and political action committees supporting a streamlining of F.D.A. policy or other issues of importance to medical products producers.”

Deborah DiSesa Hirsch is an award-winning health and technology writer who has worked for newspapers, magazines and IBM in her 20-year career. To read more of her articles, please visit her columnist page.

Edited by Jennifer Russell
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