If Schoolhouse Rock taught us anything about bills, it's that, "it's a long, long journey to the capitol city; it's a long, long wait while I'm sitting in committee." A similar slow and stalled fate likely awaits a bill introduced in the Senate last week that aims to force medical device manufacturers to monitor implants once they are on the market. But even if the bill doesn't eventually become a law, the proposed legislation serves as quite the kicker to a turbulent year for the medical device market marked by a vaginal mesh uproar, the never-ending metal-on-metal hip implant controversy, and the Institute of Medicine's (IOM) critique of the existing 510 (k) process.
The bipartisan bill--backed by Herb Kohl (D-WI), Richard Blumenthal (D-CT), and Charles E. Grassley (R-IA)--would expand FDA's postmarket authority to include oversight of implants that have been cleared for use via the 510 (k) process. If adopted, the bill would empower the agency to order medical device manufacturers to conduct safety studies of implants after they've hit the market. It would also heighten federal scrutiny of medical device recalls, according to a recent article in the New York Times. In fact, the senators have already been busy trying to gather data on recalls; they sent letters to Medtronic, Johnson & Johnson, Boston Scientific, Zimmer, and C.R. Bard requesting information on how the industry leaders track product safety and recalled medical devices.
"Faulty medical devices, especially those implanted in the body, can have disastrous health impacts on patients," Kohl said in a statement. "This legislation will help ensure that FDA can act quickly and decisively when there's a problem, and that the drive toward getting new technologies to market won't come at the risk of patient safety."
But would it really be that easy? It's unlikely. FDA has the unfortunate position of coming under fire from all sides: Patient advocacy groups point to heavily publicized recalls as proof of a flawed approval system while the medical device industry gripes about the potential to stifle innovation as well as agency inefficiencies. So, to assume that this bill would "ensure that FDA can act quickly and decisively when there's a problem" seems somewhat unrealistic.
The point may be moot, however, as the bill is expected to face serious opposition on Capitol Hill, especially in the face of several bills supported by the medical device industry. "While the bill...most likely faces an uphill fight, it may serve as a negotiating chip in a Congressional debate next year over FDA device regulation," according to the Times.
Regardless of the outcome, the introduction of this bill does seem to signal a rocky road ahead for the medical device industry. The ongoing metal-on-metal hip implant controversy, high-profile FDA warning about vaginal mesh, and IOM report have all added fuel to the already blazing FDA 510 (k) fire. But it's only a matter of time before someone gets burned. --Shana Leonard