Two days ago, it was reported that Dr. Daniel Schultz resigned from his post as the head of the FDA’s medical devices division. Earlier this year,  nine scientists wrote letters to President Obama and other political leaders alleging that there was “systemic corruption and wrongdoing that permeates all levels of FDA,” including within the medical device approval process, which put the safety of Americans at risk.

The scientists claimed that they were pressured to approve certain devices and threatened those that failed to do so with disciplinary action.  In one glaring example, the scientists claim Dr. Schultz approved a Regan Biologics knee repair device in 2008, despite the scientists’ repeated rejections of the device because it posed “an increased risk” in comparison to similar devices.

In a January hearing, the Government Accountability Office criticized the FDA, saying the agency had not been inspecting the production of medical devices as regularly as it was required to. High-risk devices, such as pacemakers, should be inspected every two years but the agency had been inspecting high-risk products only every six years.

This development highlights the importance of passage of the Medical Device Safety Act, which would restore the right of patients injured by faulty medical devices to hold manufacturers accountable.  The safety of millions of Americans with medical devices should not be put in the hands of one person at the FDA.  The civil justice system provides an independent check and balance on corporations to ensure that their products are safe.

Tags: FDA, FDA safety, Government Accountability Office, Medical Device Safety Act

This entry was posted on Thursday, August 13th, 2009 at 10:30 am and is filed under Legislation. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.