FDA Bowed to Industry Pressure in Approving Knee Replacement Device, Official Admits
The Food and Drug Administration threw out its own rule book and caved in to medical device company pressure in approving a knee-replacement device despite serious questions about its safety, the agency’s top lawyer said.
The 2008 approval of ReGen Biologics’ Menaflex device, which is used for meniscus surgery, “constitutes a clear deviation from the principles of integrity used in this review and undermines the ability of the agency to counter the suggestion that lobbying on behalf of ReGen affected the decision,” an internal FDA probe of the incident has concluded.
FDA Acting Chief Counsel Michael Landa, who conducted the review, said the FDA’s decision to overrule its own scientists, who had twice rejected the ReGen device, raises serious questions about how the agency is affected by industry pressure and other outside forces.
Joshua Sharfstein, the deputy director of the FDA, said in a conference call that the report shows there were “definite threats” to the integrity of the FDA’s medical device review process, according to a report in The Wall Street Journal.
Daniel Schultz, the FDA director who signed off on approval for the device, has since left the agency, officials said.
510k Approval Process Questioned
The ReGen knee-replacement was granted the OK under an expedited FDA review process called a 510k approval. The streamlined review is supposed to be used only for products that are essentially the same as other products already approved, but some critics say companies abuse the process by using it for more complicated devices.
The FDA recently asked for an independent audit of its 510k approval process to see if it is being abused by manufacturers to rush devices through the process. The jury is still out on that question.
Will FDA See the Light?
It’s unclear what impact the FDA’s mea culpa on the ReGen approval will have on the future of medical-device approvals. Will the FDA emerge gun shy and more careful about approving devices that have raised safety concerns? Or, when the dust settles, will the agency go right back to rubber stamping approval requests for companies that put pressure on the FDA without sufficient review?
Only time will tell.
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