Reviewers: 'longstanding corruption' at the FDA

Share this article:
Echoing earlier complaints by drug reviewers, now medical device reviewers at the FDA have begun complaining to Capitol Hill and the Obama administration about allegedly improper management pressures on their work, and the targeted managers have retaliated by opening a criminal investigation against the dissidents.

In a heavily documented letter to the Obama transition team and the New York Times in January, nine unnamed physicians and scientists cited what they termed “independent facts” to allege “longstanding pandemic corruption” in the Center “that cries out for new leadership at FDA from the bottom up.”

The independent facts they cited came from an unnamed federal judge's decision and findings of fact last year in an Equal Employment Opportunity Commission case that found supervisors in the FDA Center for Devices and Radiological Health, including Office of Device Evaluation director Donna Bea Tillman, “knew or should have known of the hostile work environment” that had resulted from managers' efforts to force unscientific approvals.

Tillman, a 2005 appointee of CDRH director Daniel Schultz, “Shockingly...herself testified in court that she was aware of the ‘hostile work environment' but ‘did not want to get involved,'” the dissidents said in their letter to Obama. The dissidents also complained that after conducting an investigation into their issues last year, Schultz concluded that they needed to “move forward” without him taking any curative or disciplinary action. 
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete September 2014 Digital Edition

Read the complete September 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.

Medical marketing needs mainstream Mad Men

Medical marketing needs mainstream Mad Men

Agencies must generate emotional resonance with the target audience, not unlike Apple, Pepsi or Nike

Are discounts cutting out co-pays?

GSK's decision to cut Advair's price spurred some PBMs to put it back on formulary. Will drugmaker discounts diminish the need for loyalty programs? How can these programs stay relevant beyond giving co-pay assistance?