The Food and Drug Administration said Thursday that it is reevaluating its approval of a knee-surgery device after a highly unusual internal review found that federal regulators may have been swayed by political pressure.
“There were definite threats and problems with integrity of the review process for this device,” said Joshua M. Sharfstein, the deputy commissioner of the FDA, who ordered the review shortly after he arrived at the agency in March.
The device, called Menaflex and manufactured by ReGen Biologics of Hackensack, N.J., is a surgical mesh used to help repair torn meniscus tissue in the knee.
Sharfstein said the FDA is not pulling the product from the market while the agency conducts a fresh review to make sure it meets safety and efficacy standards. For patients with the device, “this report is not a reason to panic,” he said.
The internal report comes about a month after the top FDA regulator in charge of medical devices, Daniel Schultz, was forced out amid charges by agency scientists that they were pressured to approve devices. The report offered several recommendations to insulate FDA staff from outside pressures, all of which will be adopted, Sharfstein said.
Diana Zuckerman, president of the National Research Center for Women and Families, a health advocacy group, said the internal review was extraordinary. “Whenever the agency looks backwards and says, ‘We made a mistake and we want to fix it,’ that’s a very big deal,” she said. “It’s unprecedented.”
The internal review flagged problems in the way the FDA regulates the $200 billion-a-year medical-devices market. For years, public health groups, consumer organizations and critics in Congress and at the Government Accountability Office have complained that FDA regulators are not properly vetting devices that are implanted in the human body. Those criticisms grew especially loud in the waning days of the Bush administration.
FDA staff scientists rejected ReGen’s application for approval for Menaflex three times, citing concerns that patients might suffer adverse impacts or that the product would do little to help them heal from a torn meniscus. The company sought a fast-track approval that is given to products which are substantially similar to other products already on the market. But several FDA reviewers believed it was, in fact, a new product, which would have required extensive clinical trials proving safety and efficacy.
In late 2008, ReGen appealed to then-FDA Commissioner Andrew von Eschenbach. He ordered an expedited review by a panel of independent advisers and allowed ReGen input about the composition of the panel. The internal probe found that ReGen executives had unusual access to von Eschenbach and approval came after von Eschenbach met several times with members of the New Jersey congressional delegation. In December, von Eschenbach approved the company’s application without any explanation for overruling the judgment of his staff.
On Thursday, Gerald E. Bisbee Jr., ReGen’s chairman and chief executive officer, said Menaflex was safe and effective and remains legally available.