The prestigious scientific panel was supposed to fix flawed medical-device regulations. Instead, the Institute of Medicine experts recommended an unrealistic and unnecessarily harsh prescription: blowing up the current route to market for many moderate-risk products.
The stunning recommendation is nonbinding but could not be more ill-timed. Economic storm clouds are gathering again.
Instead of reducing the uncertainties faced by an industry providing well-paying jobs in Minnesota and across the nation, the panel amplified the unknowns with its call to scrap the decades-old 51-(k) clearance process and start over.
The process, concluded a panel of mostly academic experts, "lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and ... cannot be transformed into one."
So much for enticing already scarce venture-capitalist dollars back to this industry. Or stemming the tide of research and development jobs moving offshore -- something documented by a PricewaterhouseCoopers report earlier this year.
The panel's work also did nothing to enhance patient safety -- the most important concern of all. The U.S. Food and Drug Administration (FDA) began weighing changes to the process in part because of a small but highly publicized number of medical-device recalls.
Industry also has long been frustrated with the unpredictability of the process, its expense and lack of transparency.
Congress, given its political divisions and budget challenges, is unlikely to prioritize or agree on a device regulation overhaul. The FDA, which asked the IOM to help strike the best balance between patient safety and industry concerns, is on its own again after waiting nearly two years for clarity.