Wall Street Journal Article
FDA Wrestles With Undoing Decision
Agency Enters New Territory as Panel of Experts Re-Examines Approval of Knee Device, Now Doubted
By ALICIA MUNDY
WASHINGTON (March 22, 2010) - The Food and Drug Administration ("FDA") is struggling to determine whether it has authority to re-evaluate a knee device that it had earlier cleared, raising questions about the scope of the agency's powers and injecting fresh uncertainty into the medical-devices sector.
The questions have emerged ahead of an FDA meeting of outside orthopedic surgery experts Tuesday. An agency committee will re-examine the Menaflex knee-repair device made by ReGen Biologics Inc..
The head of the FDA's device division had approved the knee device in December 2008 after repeated objections from FDA scientists and managers. After an Wall Street Journal article last year revealed that outside pressure had been applied in the approval process, then-incoming FDA Deputy Commissioner Joshua Sharfstein initiated an investigation. He ultimately decided to review the device again, a highly unusual step.
ReGen, a small Hackensack, N.J., company, has said its product, which is implanted to fix torn meniscus tissue in the knee, is safe. Through a spokeswoman, it has questioned the legality of the advisory panel meeting and the new evaluation.
The FDA hasn't come to a final conclusion in its re-evaluation of Menaflex. Minutes of an internal meeting in January to prepare for Tuesday's panel underscored concerns among some regulators over potential limits to the agency's authority to revoke an approval, and over the kinds of safety and efficacy issues the FDA could present to the advisory committee.
"If we cannot take the device off the market, does it help to have a panel decision one way or the other?" asked one FDA scientist during the Jan. 8 meeting, according to the minutes, which were reviewed by the Journal. The meeting attendees included the head of the device division, agency attorneys and scientists.
One FDA lawyer said the agency was "treading new ground" in the Menaflex re-evaluation.
Another regulator asked, if the product is "still on the market, what is the [legal] basis for going back to an advisory panel on a device that is previously cleared?"
Uncertainty over the FDA's ability to re-open approved cases could result in more intense agency scrutiny of medical-device applications, so as to avoid another controversy like the Menaflex approval, said some agency officials.
Longtime industry lobbyist Jeffrey Gibbs said "that slowdown is already happening." He added that he knew of several device applications that were unexpectedly rejected by the agency recently.
An FDA official said the agency was meeting its quotas for completing medical device reviews.
Mr. Gibbs said that if the FDA could withdraw clearances for approved devices, it could create uncertainty for the industry and chaos for doctors who have used the product for patients. That said, the FDA has only limited options on how to deal with devices after they are cleared, he argued. "Congress has laid out reasons the FDA can revoke an approval, and none of them includes, 'We goofed,'" he said.
An agency official said the FDA has the power to re-evaluate an approved device.
The new review follows the release of a critical report by the FDA in September saying the agency, in approving Menaflex, had bowed to "extreme" pressure from some members of Congress and lobbying by the company. The FDA assembled a new review team that didn't include the scientists who had earlier rejected the device and a new advisory committee panel.
ReGen's chairman Gary Bisbee said through a spokeswoman on Friday that "the FDA has no legal basis on which to conduct this re-review."
In a November letter to the FDA, the company said it has been severely damaged by the controversy. ReGen says Menaflex has been used in 220 surgeries in the U.S and about 3,000 in Europe, where it has been on the market for several years.
Dr. Sharfstein said in an interview that the FDA's new review team would present its analysis directly to the advisory panel, which didn't happen at the previous committee meeting.
In 2008, in the wake of complaints by ReGen that the FDA's review group was biased against it, the FDA's then-leaders didn't allow those FDA scientists to address the advisory committee to explain their objections to approving the knee device. The 2008 advisory panel generally agreed that the device was effective, but some members later said the committee process was flawed.
"The FDA is committed to a fair and thorough decision-making process on this device, including obtaining key scientific input from the expert panel this week," Dr. Sharfstein said.
Dr. Sharfstein said it "will explain the scientific and legal basis of its decision."
The FDA had approved the knee device through an abbreviated review process, called 510(k). To qualify for the process, companies must show that their product is similar to devices already on the market.
The new review team's analysis, says Menaflex doesn't meet the standards for the abbreviated 510(k) approval because it "is intended for replacement," not merely "repair" of important knee tissue. The FDA's formal statistical review said the company's data "raises several concerns regarding the safety and effectiveness" of Menaflex.
The agency hopes to reach a decision soon. Dr. Sharfstein said it "will explain the scientific and legal basis of its decision."
The FDA had approved the knee device through an abbreviated review process, called 510(k). To qualify for the process, companies must show that their product is similar to devices already on the market.
The company says its knee device was properly approved and that the FDA "is attempting to undermine the clearance" through questions that are "irrelevant" to 510(k) standards.
Help for Knee Replacement Patients
Hundreds of people who received a ReGen Menaflex knee implant now face a painful reality - the products in their bodies may be defective and need to be replaced. If you have a ReGen Menaflex knee implant in your body, you should speak with your doctor. Symptoms of defective implants include pain and reduced mobility.
Then contact Hughes Ellzey, LLP, at 1-888-350-3931.
You should also complete the ReGen Menaflex Knee Implant Client Questionnaire and return it to our office as soon as possible. The ReGen Menaflex law firm of Hughes Ellzey, LLP is seeks to obtain compensation for individuals who received the ReGen Menaflex defective knee implant. ReGen knee implant lawyer W. Craft Hughes will work to help you obtain the compensation you deserve. This compensation can include money for replacement surgery, related medical bills, physical therapy, lost of income and pain and suffering.
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