A top medical device regulator’s work overlapped at times with his wife’s legal representation of clients with business before the agency.
Two members of Congress have asked an inspector general to investigate whether the top federal regulator for medical devices like pacemakers and artificial hips acted ethically in work that overlapped with that of his wife, a leading lawyer for device companies.
The lawmakers cited an investigation by The New York Times that examined the intersection of the work of the regulator, Dr. Jeffrey Shuren of the Food and Drug Administration, and his wife, Allison Shuren, a co-chair of the drug and medical device practice at the prominent Washington office of Arnold & Porter.
The two House Democrats who wrote a letter seeking an inquiry are Representatives Anna Eshoo, of California and ranking member of the health subcommittee, and Rosa DeLauro, of Connecticut and ranking member of the appropriations committee.
The Times found several instances in which the couple’s work overlapped and could have posed conflicts of interest requiring Mr. Shuren’s recusal. The F.D.A. acknowledged ethics violations, saying that Dr. Shuren should have stepped aside or sought approval to be involved in two matters to “avoid any potential appearance of bias.”
“In circumstances such as these,” the congresswomen’s letter to the inspector general, Christi Grimm, said, “the only way to get to the truth and be fair both to the public and 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.”
A spokeswoman for the inspector general’s office of the Health and Human Services Department said that the letter was received Tuesday and that “we are reviewing it for appropriate action.”