The Washington Post reports that the FDA may try to recall a device that was approved for repairing damaged knee joints. The report says that the device was originally approved with little testing under rules that allow fast-track approval for products that are similar to other products already on the market.
Apparently FDA scientists thought more testing needed to be done, but the product was approved because of political pressure.
The FDA has a tough job. It has to assure the efficacy and safety of new drugs and medical devices. But there’s no way to show that anything is completely safe. There has to be a balance between assuring safety and making products available to help patients in need.
I don’t know how much need there was for this knee joint replacement product. It may be that getting it to market quickly helped far more people than it hurt. Ideally, though, it would be good if objective decisions about benefits and risks could be made without political interference. But it’s also important that the folks at the FDA not be allowed to spend too much time and resources assuring safety if in doing so they block patients’ access to helpful new treatments.