The FDA said it plans to revoke approval of Menaflex, ReGen Biologics' knee implant, after a 2009 review found four New Jersey congressmen and the FDA commissioner had improperly interceded in the approval process, according to a report by the Wall Street Journal.
The action is unprecedented in a number of ways. Never before has the FDA admitted it approved a drug or device mistakenly, rescinded such an approval without citing new product information, admitted a regulatory decision was influenced by politics, or accused a former commissioner of questionable conduct.
Incident puts 510(k) quick-approval process into question
Menaflex was approved in Dec. 2008 under the 510(k) clearance process, which allows relatively fast approval if the product is substantially similar to other products already on the market. The new FDA internal review last year found Menaflex is "technologically dissimilar from devices already on the market" and the 510(k) clearance was improper. The FDA is in the midst of a full review of its 510(k) process that may be completed in the next few months and could result in tighter regulations. The Advanced Medical Technology Association, representing device makers, called changes in the 510(k) process "potentially disruptive."
FDA overruled its own scientific findings
The 2009 internal review noted FDA scientific reviewers had repeatedly and unanimously declared Menaflex unworthy of approval over many years, but that they had been overruled by agency managers after political pressure from four Democrats from New Jersey: Sens. Robert Menendez and Frank R. Lautenberg and Reps. Frank Pallone Jr. and Steven R. Rothman. All four lawmakers had received significant campaign contributions from ReGen, based in Hackensack, N.J. The report also found Andrew C. von Eschenbach, MD, then the agency’s commissioner, had become inappropriately involved in the decision.
Menaflex could stay on the market for up to one year
FDA officials said it could take up to a year to revoke the Menaflex approval and the device could remain on the market until then. ReGen said it was still 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," the company said in a statement.
Read the Wall Street Journal report on the FDA.
Read more on FDA actions:
-FDA Considers Impact of Reversing Its Decision on Knee Device
-FDA Sends Johnson & Johnson Letter of Warning
-FDA Releases 21 Draft Transparency Proposals for Public Comment
The action is unprecedented in a number of ways. Never before has the FDA admitted it approved a drug or device mistakenly, rescinded such an approval without citing new product information, admitted a regulatory decision was influenced by politics, or accused a former commissioner of questionable conduct.
Incident puts 510(k) quick-approval process into question
Menaflex was approved in Dec. 2008 under the 510(k) clearance process, which allows relatively fast approval if the product is substantially similar to other products already on the market. The new FDA internal review last year found Menaflex is "technologically dissimilar from devices already on the market" and the 510(k) clearance was improper. The FDA is in the midst of a full review of its 510(k) process that may be completed in the next few months and could result in tighter regulations. The Advanced Medical Technology Association, representing device makers, called changes in the 510(k) process "potentially disruptive."
FDA overruled its own scientific findings
The 2009 internal review noted FDA scientific reviewers had repeatedly and unanimously declared Menaflex unworthy of approval over many years, but that they had been overruled by agency managers after political pressure from four Democrats from New Jersey: Sens. Robert Menendez and Frank R. Lautenberg and Reps. Frank Pallone Jr. and Steven R. Rothman. All four lawmakers had received significant campaign contributions from ReGen, based in Hackensack, N.J. The report also found Andrew C. von Eschenbach, MD, then the agency’s commissioner, had become inappropriately involved in the decision.
Menaflex could stay on the market for up to one year
FDA officials said it could take up to a year to revoke the Menaflex approval and the device could remain on the market until then. ReGen said it was still 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," the company said in a statement.
Read the Wall Street Journal report on the FDA.
Read more on FDA actions:
-FDA Considers Impact of Reversing Its Decision on Knee Device
-FDA Sends Johnson & Johnson Letter of Warning
-FDA Releases 21 Draft Transparency Proposals for Public Comment