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Posted by on Jan 28, 2009 in Ethics, FDA

FDA Wars: The Empire Strikes Back With Criminal Investigation of Rebelling Scientists

FDA Wars: The Empire Strikes Back With Criminal Investigation of Rebelling Scientists

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Bum-bum-bum, bum-ba-dum, bum-ba-dum.
Bum-bum-bum, bum-ba-dum, bum-ba-dum.

Sorry.

Nine FDA scientists who complained to the House Energy and Commerce Committee and Obama’s transition team about lax medical-device reviews at the FDA’s Center for Devices and Radiological Health (CDRH) are now targets of an internal criminal investigation, writes Gardiner Harris in today’s NYT. The scientists reported this new development in their ongoing struggle with CDRH’s management in a letter sent to President Obama on Monday and also provided to the paper.

Harris quotes the letter: “It has been brought to our attention that FDA management may have just recently ordered the FDA Office of Criminal Investigations to investigate us rather than the managers who have engaged in wrongdoing! It is an outrage that our own agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress.”

Harris implies that the alleged criminal investigation may relate to the scientists’ sharing of confidential CDRH documents, including e-mail messages, with the NYT. On January 12, Harris wrote that a CDRH supervisor overruled agency scientists and approved iCAD’s SecondLook Digital Computer-Aided Detection System for Mammography, after receiving a phone call from former Connecticut congressman Christopher Shays. The device is used in conjunction with screening equipment made by Fujifilm Medical Systems, which is based in Stamford, CT, the center of Shay’s former district. Harris’s article was evidently prompted by FDA documents, which were given to the NYT by the dissident scientists.

Harris also wrote that a recent report from the Government Accountability Office largely validated the FDA scientists’ claims of a broken approval process at CDRH.

bmartin (1130 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.