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.”
The F.D.A. and Dr. Shuren did not immediately respond to requests for comment.
In July, Dr. Shuren announced that he was retiring from his role as director of the medical device division and was taking on an emeritus role in the commissioner’s office.
Ms. Shuren, a prominent lawyer in the ophthalmology field, is described on the Arnold & Porter website as “a trusted adviser for international manufacturers of medical devices” who “regularly interacts with the U.S. Department of Health and Human Services Office of Inspector General.” She was paid $1 million to $5 million in 2018, the one year that Dr. Shuren reported his wife’s salary in ethics documents.
Dr. Shuren was named director of the F.D.A. medical device division in 2010 and had an ethics agreement in place at the start, agency records show. He was expected to step aside if business involving his wife’s clients came before his division.
In 2014, he failed to do so, the agency confirmed, when he signed an appointment of eight members of a 12-person panel that considered approval of a lens implant by Alcon, an eye care drug and device maker and a client of Ms. Shuren’s. The panel voted to approve the device.
In 2015, court records and interviews showed that Dr. Shuren said he was recused from matters related to Theranos, the discredited blood-testing start-up. At the time, Ms. Shuren’s co-chair at the law firm was representing Theranos and calling on the F.D.A. to halt an inspection of the company’s California offices. Yet Dr. Shuren was involved, the F.D.A. confirmed, though it remains unclear to what extent.
In 2017, Dr. Shuren signed an updated ethics agreement that described how he tried to help the F.D.A. oversee his pledge to sidestep matters involving Arnold & Porter clients. The document said he sought a list of his wife’s clients from the firm, but it declined to provide it.
Issara Baumann, a spokeswoman for Arnold & Porter, said in a statement in July that the firm “has long had strict protocols in place to assure full compliance with respect to our professional obligations and the F.D.A.’s requirements governing financial conflicts of interest and impartiality.”
In another instance, the agency said Dr. Shuren did not need to recuse himself from its oversight of LASIK lasers. Patient groups that claimed harm from the procedure have sought stronger warnings.
Dr. Shuren announced a proposal to add stark warnings in 2022. Soon after, Ms. Shuren’s clients, Alcon, which makes LASIK lasers, and the Society for Excellence in Eyecare, a group of ophthalmologists, urged the F.D.A. to withdraw the plan. The agency said the proposal remained under review.
Richard Painter, a former government ethics lawyer, said he would not have signed off on Dr. Shuren’s 2017 ethics agreement. He said Dr. Shuren was bound by ethics regulations and criminal laws to uphold trust in government and to keep officials from profiting from their roles.
“There ought to be an I.G. investigation,” Mr. Painter, a law professor at the University of Minnesota, said. “There’s a lot we don’t know here.”
Dr. Rita Redberg, a University of California San Francisco professor and cardiologist who has studied medical device oversight, said an investigation should proceed to determine if there were additional areas where the couple’s work overlapped.
“We need to know if that’s the tip of the iceberg,” she said. “Hopefully it’s not, but it’s important to know, because we’re talking about patient safety and patient lives.”
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