Dysfunction at FDA threatens medical genetics industry

FDA green

According to Jon Entine, after a series of stumbles and scandals, the Food and Drug Administration’s ability to oversee the most cutting edge sectors of the medical industry, medical device and genetic screening tests, is under increasing scrutiny.

The Food and Drug Administration and its Center for Devices and Radiological Health (CDRH) is reeling.  In mid July, the New York Timesaccused the FDA of creating a massive e-mail surveillance program designed to net junior scientists and other critics who complained the agency was too-quick to approve medical devices that the employees maintained posed unacceptable health risks.

The Times’ story generated national headlines with its sympathetic portrayal of harassed scientists risking their careers to protect the public interest. But new revelations suggest the Time’s slanted the story by leaving out critical context. It appears that dissident employees are involved in what could be seen as an ambulance chasing shakedown scheme to profit from their allegations. In December 2009, while these “aggrieved” reviewers were publicly lobbying the FDA and Congress to crack down on scanning devices, they had secretly filed a whistleblower lawsuit against these very same manufacturers that if successful could make them multi-millionaires.

View the original article here: Dysfunction at FDA threatens medical genetics industry

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