The perennial debate about the appropriateness of FDA's regulation of medical devices had an airing in the Wall Street Journal recently. Reporter Thomas Burton brought together a former FDA deputy commissioner, cardiology professor and device attorney to hash it out. While the back and forth is fairly predictable, a few comments were made that bear repeating.
When asked if FDA's current approach stymies innovation or, on the contrary, does not provide sufficient safeguards in respect to patient safety, Scott Gottlieb, former FDA official and a resident fellow at the American Enterprise Institute, says the FDA has lost its way and erected unnecessary barriers to innovation.
"FDA's approach to regulating devices, in contrast to its requirements governing drugs, was designed by Congress to recognize that not all devices pose the same degree of risk," Gottlieb told Burton. Noting that the regulatory burden should be commensurate with the potential risk of the device to the patient, Gottlieb said that the "problem today is the FDA has deviated from the original spirit of that idea."
While faulty medical devices have made headlines in recent years—metal-on-metal hips and defibrillator wires are well-known examples—it is worth noting that thousands of medical devices are cleared each year. How many of those turn out to be unsafe or ineffective, Bradley Merrill Thompson, an attorney with Epstein, Becker & Green (Washington, D.C.), asked rhetorically. "Not many," he added, with which Gottlieb concurred: "Keep in mind that 99.8% of all medical devices have no serious adverse events associated with them," he said.