The Food and Drug Administration of U. S. failed to comply with its own rules when it approved a knee repair product last year despite not being recommended by its won scientists.
Recently appointed FDA Deputy Commissioner Josh Sharfstein, recently requested a report to be filed wherein it was found that the approval of ReGen Biologics' Menaflex device raises serious questions about the fact that the FDA might have bent in front of the pressure from the company.
FDA leaders confirmed that they were planning to review the device but would not pull it off the market yet. Sharfstein appealed to the patients not to panic because of the report since the device was approved by the FDA therefore there was no basis to question its safety.
Although the device was approved by the authorized person after due review still nine scientists from the device division wrote to the Obama transition team complaining that they were pressured to give their approval against their judgment. The FDA had twice rejected the company's request for approval when a special panel was called upon to discuss the company's device and was finally approved.
Sen. Charles Grassley, R-Iowa, a longtime critic of the FDA's device program said, "The report today is more good news about the FDA recognizing the shortcomings in its review process for the majority of medical devices."












