Internal FDA probe uncovers widespread problems with approval decision for knee implant

FDA approved device despite problems during review

WASHINGTON — The Food and Drug Administration failed to follow its own rules when it approved a knee repair product last year against the recommendation of its own scientists, according to an internal probe.

The report, requested by recently appointed FDA Deputy Commissioner Josh Sharfstein, found the approval of ReGen Biologics’ Menaflex device raises serious questions about whether agency leadership caved to pressure from the company.

It details a series of problems which “constitutes a clear deviation from the principles of integrity used in this review.”

FDA leaders said Thursday they are reviewing the decision to approve the device, but are not pulling it off the market.

“This device has been cleared by FDA and we have no basis to question the safety,” said Dr. Jeffrey Shuren, acting director for medical devices.

Sharfstein stressed to patients that the report is “not a reason to panic.”

“This is not a review that finds a specific safety problem with the device, this is about the process,” he told reporters.

Regen on Thursday stood by the safety and effectiveness of its device, saying in a statement that the FDA’s review involves “procedural irregularities” at the agency.

Still, FDA scientists twice rejected Regen’s device between 2006 and 2008.

In a 2007 rejection letter to the company, an FDA reviewer said the company’s device had “an increased risk” compared with products already on the market. In another letter, scientists said Regen had not shown “that patients who received the device experienced any benefit.”

Despite those concerns, the FDA’s former device division chief Daniel Schultz overruled those decisions and approved the product late last year.

Schultz retired last month.

The report acknowledges that Schultz had authority to approve the device “so long as he did so for legitimate reasons.”

“The record, however, does not supply a basis for his reversal adequate to dispel questions about the role of outside pressures,” the report concludes.

Earlier this year, nine scientists from the device division wrote to the Obama transition team complaining they were pressured to approve medical devices against their judgment.

Hackensack, N.J.-based Regen approached the FDA in 2005 to request its device be approved under the so-called 510k system. Under the procedure, companies can win speedy approval for devices that are similar to products already on the market.

The FDA told the company that its implant did not meet the 510k criteria and would have to go through the traditional approval process — a more costly, time-consuming process involving clinical testing.

After the FDA twice rejected the company’s request for fast-track approval, Regen enlisted the support of New Jersey lawmakers, who called then-FDA Commissioner Andrew von Eschenbach on the company’s behalf.

The agency then scheduled a special panel meeting to discuss the company’s device, which was ultimately approved Dec. 20.

Von Eschenbach declined to be interviewed for the agency’s report, according to the FDA.

Thursday’s announcement came one day after the FDA said it is asking the Institute of Medicine to review the 510k approval system.

The procedure was originally intended to speed the approval of simple devices like bandages and wheelchairs, but in recent years it has been used to approve high-risk devices like artificial joints.

Sen. Charles Grassley, R-Iowa, a longtime critic of the FDA’s device program, welcomed both announcements.

“The report today is more good news about the FDA recognizing the shortcomings in its review process for the majority of medical devices,” Grassley said in a statement.