New York Times Examines FDA Market Approval of Medical Devices

The New York Times on Monday -- as part of an ongoing series titled "The Evidence Gap" -- examined how FDA each year allows "thousands" of medical devices onto the market with "only cursory review and with no clear evidence that they help patients." According to the Times, physicians "are free to use those products as they see fit, without telling patients that the devices are not proved." CMS "frequently" provides higher Medicare payments to physicians who use such products "as a way to compensate them for the extra time and expense of adopting new procedures," which can lead to the devices becoming "widely adopted," the Times reports.

Critics of FDA's process for reviewing medical technology say that the agency "is often too lax" and that medical devices should be held to the same review standards as prescription drugs, which typically are "studied in hundreds or even thousands of patients before the FDA will approve it as safe and effective," according to the Times. Diane Robertson -- an executive with the ECRI Institute, which evaluates new devices for hospitals and insurers -- said, "Nobody is looking to see whether [the devices] help patients," adding, "We're never going to wisely allocate resources in health care unless we start to focus on what's best for patients."

FDA officials say that the quick-review process promotes innovation and that because most new devices improve upon an existing device there rarely is a need for full review. Daniel Schultz, director of the Center for Devices and Radiological Health at FDA, said that expecting a full review of the devices would be "very, very inappropriate and a waste of resources." The Government Accountability Office in November is expected to release a report on FDA's medical device review process following a congressional request, according to the Times.

The Times profiled the device MammoSite, a new breast cancer treatment system marketed by Massachusetts-based Hologic, that received FDA market approval in 2002. The system was approved following a clinical study involving 25 patients, which failed to show the effectiveness of MammoSite in treating breast cancer. Many cancer specialists say that six years later, "there is still no conclusive proof that it works as well as conventional radiation," according to the Times. FDA says it did require a label warning to inform consumers that the device is not proven to be a substitute for standard radiation (Abelson, New York Times, 10/27).