The Food and Drug Administration is defending the record of Jeff Shuren, former director of the agency’s medical device center, after The New York Times reported on how his role intersected with his wife’s work as legal counsel for medtech companies.
Shuren’s wife, Allison Shuren, is co-chair of the life sciences and healthcare regulatory practice at law firm Arnold & Porter, and represented medical device companies. Shuren led the FDA’s Center for Devices and Radiological Health for 15 years and, in July, announced he would retire. Shuren will stay with the agency as it finds and transitions to a new leader.
The CDRH authorizes new medical devices to enter the U.S. market and monitors product safety through postmarket surveillance and recalls.
The FDA defended Shuren in an email to MedTech Dive amid the ethics controversy raised by the Times and a patient safety advocate.
“FDA has no indication that any FDA regulatory decisions were impacted by Dr. Shuren’s wife’s employment nor that Dr. Shuren made any decisions in the interest of parties other than the public served by the FDA,” agency spokesperson Shannon Hatch said in the statement.
The Times article examined potential overlap between the work of Shuren and his wife in cases involving the discredited blood testing company Theranos, Allergen’s breast implant recall, which came after the devices were connected to a specific form of cancer, and a proposal to strengthen regulation of LASIK eye surgery.
The FDA, which reviewed the information raised by the Times, found no evidence Shuren violated the criminal conflict of interest statute, according to Hatch.
Still, “it appears there were certain instances from about 10 years ago for which Dr. Shuren should have either recused himself or sought ethics authorization to participate to avoid any potential appearance of bias,” said Hatch.
As a result, Shuren has been advised to exercise greater caution in matters concerning recusal obligations and is being provided additional administrative support to ensure future compliance, Hatch wrote.
A spokesperson for Arnold & Porter said the law firm has long had strict protocols in place to assure compliance with the FDA’s requirements governing financial conflicts of interest and impartiality.
“We are confident that Allison Shuren has acted in compliance with all such requirements dictated by her husband’s affiliation with the FDA,” the spokesperson wrote in an email.
Advamed, the medical device industry’s largest lobbying group, did not return a request for comment from MedTech Dive.
Shuren retires
The Times article comes two months after Shuren announced his retirement as CDRH director in an email to staff. Michelle Tarver, the FDA’s deputy director for transformation, was named acting director of the center.
In a separate July email, FDA Commissioner Robert Califf told agency staff that Shuren would transfer to the commissioner’s office and assist in the leadership transition at CDRH while the FDA searches for a permanent successor. Shuren is expected to leave the agency later this year.
The FDA is proud of Shuren’s “commitment and integrity” in serving the public over the course of his government career, said Hatch. Senior leadership is required to adhere to ethics requirements that include filing annual public financial disclosure reports. Guidance on recusal obligations and reminders of those obligations are provided during financial disclosure reviews, the spokesperson added.
“The agency stands by his science-based public health decisions and those made by others within the Center for Devices and Radiological Health, including those that were discussed in the recent New York Times article,” Hatch said.
Shuren’s ethics documents also were vetted by the FDA’s Office of Ethics and Integrity and ethics attorneys in the Department of Health and Human Services’ Office of General Counsel over multiple administrations, added Hatch.
Patient advocate groups and lawmakers have called for improvements to the FDA’s medical device safety system to better protect people from faulty products. In recent years, the FDA has faced criticism amid several high-profile product safety events that have involved patient harm tied to breast implants, Bayer’s Essure birth control device, Medtronic’s heart pump, and Philips’ years-long recall of more than 15 million respiratory machines.
The Government Accountability Office is reviewing the agency’s device recall process after a request from Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn. The Times article said reports of device-related injuries rose to 900,000 in 2023 from about 190,000 in 2012, citing an analysis of FDA data by the company Device Events.
Robert Steinbrook, director of consumer rights group Public Citizen’s health research arm, called on the HHS Office of Inspector General to launch an investigation into allegations in the Times article that Shuren did not fully recuse himself from working on matters involving clients of his wife’s firm.
“There are long-standing concerns that the FDA’s regulation of medical devices has been too friendly to industry under Shuren’s leadership and has not prioritized patient safety and the effectiveness of novel medical devices,” Steinbrook said in a statement, calling the report “very troubling.”
An HHS-OIG spokesperson declined to comment on the matter when contacted by MedTech Dive.
