FDA and the Goldilocks principle

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.

That didn't hold court with Rita Redberg, a cardiology professor at UC San Francisco. "As a cardiologist taking care of patients every week, I see too many whose lives have been harmed and who have suffered greatly from untested or inappropriate devices," she said. Only a small percentage of all medical devices enter the market via a pathway that requires at least some clinical data, Redberg added. Indeed, as Burton noted, the vast majority of medical devices reach the market via the 510(k) process, which only requires companies to demonstrate that their device is substantially equivalent to a product currently on the market. "Simply put, for the vast majority of all medical devices, there is no requirement to demonstrate safety and effectiveness," stressed Redberg.

That seems a bit harsh. While FDA is not perfect, the agency does have the tremendously difficult task of striking a balance between patient safety and allowing life-saving medical technology to be brought to market. Whereas Redberg thinks it gambles recklessly when it comes to patient safety, many in the medical device industry believe the regulatory process is unnecessarily burdensome (and over the years many companies have introduced products in Europe first, where the time to market can be considerably accelerated).

As in so many endeavors, the difficulty of achieving the Goldilocks effect—not too much or too little, but just right—was proven once again by this roundtable discussion in the Wall Street Journal.

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