We posted previously on the device industry pushback against the new IOM report urging major reforms of how the FDA regulates medical devices:
Now the New England Journal of Medicine:
--in a "Perspective" authored by their executive editor, Dr. Gregory Curfman, and Dr. Rita Redberg, the editor of Archives of Internal Medicine, adds their word of support to the IOM proposal. Some highlights from the Perspective:
Despite its reasonable (and relatively modest) recommendations, the report has been aggressively attacked by the device industry and by politicians from states where device companies are located. In fact, the attacks began even before the report was released, which is highly unusual for an IOM report.
We believe that the IOM report is insightful, judicious, sensible, and long overdue. ... Unfortunately, the FDA leadership has already suggested that it does not intend to implement this key recommendation of the report, although it may be open to other changes. As the best long-term improvements are contemplated, there are important steps that the agency can take now.
We strongly believe that, in the interest of advancing human health, patients must have easy access to innovative medical devices and that the approval process needs to be sensible and efficient. But no one’s interest is served by putting defective medical devices onto the market where they cause harm to patients, waste health care dollars, and may kill jobs when they are withdrawn. It is essential that the FDA be adequately funded to carry out its mission to ensure the safety and effectiveness of medical devices. The IOM report charts a path that is right for the future, and despite well-financed outside pressures, we urge the FDA to initiate an action plan with congressional support to adopt these important recommendations.