Christina Jewett, The New York Times, August 20, 2024
When he announced in July that he would be retiring from the Food and Drug Administration later this year, Dr. Robert Califf, the agency’s commissioner, praised him for overseeing the approval of more novel devices last year than ever before in the nearly half-century history of the device division.
But the admiration for Dr. Shuren is far from universal. Consumer advocates see his tenure as marred by the approval of too many devices that harmed patients and by his own close ties to the $500 billion global device industry.
One connection stood out: While Dr. Shuren regulated the booming medical device industry, his wife, Allison W. Shuren, represented the interests of device makers as the co-leader of a team of lawyers at Arnold & Porter, one of Washington’s most powerful law firms.
Dr. Shuren signed ethics agreements obtained by The Times that were meant to wall him off from matters involving Arnold & Porter’s business. But it’s not clear how rigorously the ethics agreements were actually enforced. His wife’s law firm refused to provide a list of clients — and the agency had no legal authority to require it, said Michael Felberbaum, a spokesman for the F.D.A.
In a review of thousands of pages of court documents and F.D.A. 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.
Her partner at the helm of the firm’s life sciences team began representing Theranos, the discredited blood testing company, in 2015, demanding that the F.D.A. halt an inspection at its sites in California. While Dr. Shuren said he was recused from the matter, court records suggested he remained involved.
In another case, Ms. Shuren’s firm was working on a $63 billion acquisition of the company Allergan in 2019 when Dr. Shuren initially declined to urge a recall of the company’s breast implants tied to a rare cancer.
The couple’s work overlapped again in 2022 when Dr. Shuren announced a proposal to strengthen warnings given to patients preparing for LASIK vision correction surgery. Two of Ms. Shuren’s clients opposed the plan; the recommendations have yet to be put in place.
Ms. Hatch confirmed that the lapses occurred in the Theranos case as well as another one identified by The Times involving Alcon, an eye care drug and device company that was a client of Ms. Shuren’s.
In 2014, Alcon went before an agency committee convened to advise on whether to approve a lens implanted in the eye. According to a meeting transcript, Dr. Shuren signed off on the appointment of eight new voting members and a new chairman for the hearing, which recommended approval.
Ms. Hatch said the agency “has no indication that any F.D.A. 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 F.D.A.”
While the agency conducts a nationwide search for Dr. Shuren’s replacement, he will work in the commissioner’s office to help ensure a smooth transition, according to the July statement by Dr. Califf announcing his retirement.
The F.D.A. said Friday, “Dr. Shuren has been advised of the need to exercise greater caution in matters concerning his recusal obligations and will be provided additional administrative support to better ensure future compliance.”
Neither Dr. Shuren nor Ms. Shuren responded to requests for interviews.
When The Times initially requested Dr. Shuren’s ethics records from the division he led, an official in the information disclosure unit wrote that the request was “complex” and would take up to two years to fill. Four months later, the F.D.A. provided an agreement that turned out to be two pages long after a lawyer for The Times had requested that a branch of the F.D.A. other than Dr. Shuren’s address the matter.
During the decade and a half of overlapping career trajectories, “Dr. Shuren has not requested, nor has he received any waiver or agency authorization to participate in any particular matter relating to his wife’s employment or any of her clients,” Mr. Felberbaum said.
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Ms. Shuren earned from $1 million to $5 million, according to her husband’s financial disclosure form in 2018, the only one that estimated her income. Dr. Shuren’s F.D.A. salary is $400,000 a year.
Dr. Shuren led an office with about 2,500 staff members and a budget of about $790 million. He oversaw thousands of devices, ranging from tests to detect blood-lead levels to IV infusion pumps to ventilators.
Dr. Peter Lurie, a former F.D.A. associate commissioner, said he hoped the next division chief would shape a legacy that is more impartial toward device companies.
A surge in injuries
Early in his tenure, Dr. Shuren dismissed criticism from the business community over what it viewed as the slow pace of device approvals compared with Europe. Citing Europe’s lower standards and safety problems, he told The Times in 2011 that the F.D.A. would stand firm.
“We don’t use our people as guinea pigs in the U.S.,” he said at the time.
But congressional leaders on both sides of the aisle pressured the agency for faster medical device approvals. By 2014, Dr. Shuren pledged to make the United States the first place for device makers to sell their products.
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In a recent presentation, he boasted that the number of first-in-the-world approvals had soared to 125 in 2023, from 25 in 2009.
Over time, Dr. Shuren drew closer to the medical device industry. In 2012, he co-founded a nonprofit called the Medical Device Innovation Consortium with a former executive from Medtronic, a leading device company.
To do so, Dr. Shuren secured a waiver from agency ethics rules, which prohibit federal officials from serving on boards of nonprofits to avoid divided loyalties or interests.
Most of the consortium’s board members were device industry executives, and many of its staff members had previously worked for the industry’s lobbying organizations.
As a board member, Dr. Shuren expanded the nonprofit while facing disturbing episodes at the agency over harm done by medical devices. Thousands of women reported injuries and side effects from Essure devices — small metal birth-control implants that dislodged from the fallopian tubes, tore delicate anatomy or caused allergic reactions. Other women were outraged to discover that an F.D.A.-cleared device called a power morcellator used to pulverize uterine growths might have actually spread their cancer.
Dr. Shuren promised in 2019 that a consortium project called NEST, or the National Evaluation System for Health Technology, would “empower the F.D.A. to more quickly identify, communicate and act on new or increased medical device safety concerns.”
The group has “obviously failed to do that,” said Diana Zuckerman, the president of the National Center for Health Research, a consumer watchdog group.
Agency critics have compared the NEST effort to a fox guarding a henhouse, citing the industry’s leadership at the consortium and a lack of specific safety accomplishments.
Last year, the American Medical Association, the nation’s largest physician group, raised “serious safety concerns” about medical devices, highlighting secrecy around reports of device-related injuries and a system that allowed many devices onto the market with little to no testing in humans.
The F.D.A. defended its approval process, saying it had increasingly sought more evidence before clearing products for sale. Regarding NEST, the agency noted a report by the U.S. Government Accountability Office, a watchdog agency, that said the program would begin monitoring the safety of two types of medical devices in December.
Medical specialists have also raised concerns about the safety and effectiveness of some devices approved during Dr. Shuren’s tenure. They include the CoolSculpting device, which was meant to zap fat but disfigured some people, and the Q-Collar sports safety device, which some experts say may offer little protection from injuries to the brain.
Reports of device-related injuries soared to 900,000 in 2023, up from about 190,000 in 2012, according to Device Events, a company that makes F.D.A. data user-friendly for subscribers.
Dr. Hooman Noorchashm, a Harvard-trained cardiothoracic surgeon, said he believes the problems are a result of low standards and deference to industry. He emerged as a critic of Dr. Shuren’s after his wife died of a cancer that he said was spread by a power morcellator.
“Essentially,” he said, “he’s pumping medical products into the U.S. marketplace, outside of an evidence-based paradigm.”
Theranos hires Ms. Shuren’s team
When Dr. Shuren was named acting director of the medical device division in 2009, agency lawyers drafted an ethics agreement to prevent conflicts of interest involving his wife and her law firm. Top officials were to screen potential issues of concern, and other agency officials were to take the lead in such cases, according to the document.
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A major test occurred in 2015. Daniel A. Kracov, Ms. Shuren’s partner in running the firm’s drug and device team, began representing Theranos.
At the time, he was challenging the F.D.A.’s authority to conduct an inspection at two Theranos offices in California. F.D.A. officials were concerned that the company was shipping its “nanotainer” blood-storage device without agency clearance. Theranos records for 2015 and 2016 show a $1.6 million payment to Arnold & Porter for legal services.
Dr. Shuren said around that time that he was recused from dealing with Theranos, recalled Alberto Gutierrez, then the F.D.A.’s senior scientist on diagnostic tests. But Dr. Gutierrez said he had not been informed that the agency expected another official to step in for Dr. Shuren, and Dr. Gutierrez continued to send him periodic emails about Theranos. Walter Brown, a lawyer for Mr. Balwani, gave the judge 91 documents that he said proved Dr. Shuren was dealing with Theranos matters.
Alison Daw, a lawyer representing the F.D.A., argued that Dr. Shuren had not had substantial involvement.
Breast implants tied to cancer
In the spring of 2019, the drug and device maker Allergan was under scrutiny at the F.D.A.: Women were developing a rare form of lymphoma linked to the company’s textured breast implants, which had been recalled by more than 30 countries.
At the same time, Arnold & Porter was engaged in legal issues involving Allergan. In April, a member of Ms. Shuren’s team began to defend Allergan in a California lawsuit over Botox pricing. The firm was also ushering AbbVie through a $63 billion acquisition of Allergan — a success Ms. Shuren’s team highlights on the firm’s website.
Mr. Felberbaum said Dr. Shuren was not aware of either the Botox case or the acquisition.
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In May, Dr. Shuren and another F.D.A. official announced that the implants would not be recalled. In June, AbbVie announced its decision to purchase Allergan for $63 billion.
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