Nine FDA scientists who admitted to being forced by FDA higher up’s to approve high-risk medical devices have now found themselves at the center of a criminal investigation. In a letter to President Obama (which was published in the New York Times, the scientists said:
“It has been brought to our attention that F.D.A. management may have just recently ordered the F.D.A. Office of Criminal Investigations (O.C.I.) to investigate us rather than the managers who have engaged in wrongdoing!”
Given my involvement on behalf of injured consumers in pharmaceutical litigation for over 20 years, this development, while troubling, is no surprise. Our regulatory safety nets have failed us and the industry refuses to police itself. Hopefully, the new administration will employ the “yes we can” mantra and begin to address this critical problem.
Richard J. Arsenault, 2011
