Over the past few years, repeated drug-safety scandals have plagued the FDA, putting the agency under fire for its performance as the nation's drug watchdog. Now, the FDA's device-approval division gets to share the pain. According to the New York Times, the agency lets thousands of new devices onto the market every year via its fast-track review program, often with little evidence that they actually work to help patients.
The FDA told the NYT that quickly reviewing devices helps promote innovation. Also, the agency said, many devices are simply incremental improvements over old devices, and as such require no full review. Requiring drug-style trials of these devices would be a bad use of resources, the FDA's director of devices and radiological health told the paper.
Under a fast-track review, a product's clinical effectiveness isn't established. Instead, regulators determine whether the device does what the manufacturer claims it will. In the case of MammoSite, a "seeding" radiation device for breast cancer treatment, the agency only tested whether it delivered radiation, not whether it works as well as conventional radiation at preventing a cancer recurrence.
Soon, we'll have more information to evaluate the agency's performance in this area: Prompted by Congressional questions about the FDA's regulation of devices, the Government Accountability Office will release a report later this month.
- see the New York Times article