Democrat Lawmakers Seek Probe of Shuren Conflicts
Two U.S. House of Representatives Democrat lawmakers are calling for an HHS Office of Inspector General (OIG) investigation into potential conflict-of-interest appearances (see story) raised in last month’s New York Times investigative article on retiring CDRH director Jeff Shuren’s regulatory role and the legal work done by his wife Allison for the same industry at the iconic industry law firm of Arnold & Porter.
“Dr. Shuren signed ethics agreements obtained by the Times that were meant to wall him off from matters involving Arnold & Porter’s business,” the article said. “But it’s not clear how rigorously the ethics agreements were actually enforced… In a review of thousands of pages of court documents and FDA records and dozens of interviews with current and former agency staff members and advocates, the Times identified some clients and several instances in which the Shurens’ roles intersected.”
In a 9/24 letter to the OIG, Reps. Anna Eshoo (D-CA) and Rosa DeLauro (D-CT) say the “article raises serious questions of appearance and serious conflict of interest,” adding that the implication is that Shuren “did not recuse himself from regulatory decisions involving clients whose interests were represented by his wife, Allison W. Shuren… In circumstances such as these, the only way to get to the truth and be fair both to the public and to Dr. Shuren is through an independent review of the matter to determine whether this is simply an appearance of impropriety or actual inappropriate and unethical conduct.”
The request for an investigation follows FDA Webview’s 9/23 reporting (see story) that despite Shuren’s departure from CDRH, the same conflict concerns remain with his hand-picked interim successor, deputy director Michelle Tarver, who continues this cozy-with-industry corruption of FDA’s patient safety mission at the Center. Similar concerns have been leveled at Tarver, an ophthalmologist with strong connections to the Bowie, MD-based LASIK-promoting eye surgery firm of Solomon Eye Physicians and Surgeons, whose Web site advertises her availability for consultations. As physicians, Shuren and Tarver are permitted to see private patients when not on duty at FDA provided that this doesn’t create a perception of a conflict of interest. In Tarver’s case such a perception might be created when she is simultaneously working on medical device company regulatory issues at CDRH.