FDA plans to revoke knee implant approval following intense political pressure for its approval

The Wall Street Journal: "The Food and Drug Administration on Thursday said it planned to revoke a medical-device company's right to sell a knee implant called Menaflex after an unprecedented yearlong review concluded the agency erred in allowing it on the market. ... The move follows a March 2009 article in The Wall Street Journal that said a team of FDA reviewers and their manager had repeatedly rejected the device because of questions about its safety and efficacy. ... In September 2009, the FDA released a sharply worded report saying 'extreme' pressure from politicians hurt the integrity of the process. The report criticized a former commissioner and two device division leaders for their role in approving Menaflex" (Mundy, 10/15).

The Associated Press/USA Today: "ReGen, based in Hackensack, N.J., asked the FDA in 2005 to approve its device under the so-called 510k system, which allows speedy approval for devices that are similar to products already on the market. ReGen argued that the Menaflex was comparable to shoulder joint implants sold by Johnson & Johnson, Stryker and other companies. FDA scientists rejected that argument again and again over several years, saying the device should go through a more rigorous approval pathway that requires patient testing. The head of FDA's device division overruled those scientists in late 2008. The agency said Thursday they were actually correct and that Menaflex is 'technologically dissimilar from devices already on the market.' The FDA is overhauling the 510k system for approving medical devices, after several outside reports suggested high-risk devices have slipped through with little scrutiny" (10/14).

The New York Times: "The FDA had never before admitted that it approved a drug or device mistakenly, never rescinded such an approval without citing new information about the product, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct. Gerald E. Bisbee Jr., chairman and chief executive of ReGen, said in a statement that the company was 'weighing its options.' 'The product has been approved and in use successfully in Europe for nearly 10 years with approximately 3,000 patients, and there has never been a safety issue associated with the device,' Dr. Bisbee said" (Harris, 10/14).

Los Angeles Times: "Four New Jersey Democrats — Sens. Frank R. Lautenberg and Robert Menendez and Reps. Steven R. Rothman and Frank Pallone Jr. — lobbied FDA administrators on behalf of ReGen. In early 2009, a group of FDA scientists complained to Sen. Charles E. Grassley (R-Iowa) that the Menaflex approval was one of several in which politics won over scientific decision-making" (Zajac, 10/15).

On another issue, The Associated Press reports: "The Food and Drug Administration is considering new restrictions on widely used anemia drugs that appear to double the risk of stroke in patients with kidney disease. The FDA posted its safety review of the three blood-boosting medications from Amgen Inc. on Thursday, focusing on their use in patients with chronic kidney disease who are not yet sick enough to receive dialysis" (Perrone, 10/14).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.