Democrats on the Energy and Commerce Committee in the House of Representatives want to take a closer look at defective implantable devices, such as brain stents and metal-on-metal hip implants. The legislators, including Henry Waxman (DCA), wrote a letter to committee chairman Fred Upton (R-MI) and Joseph Pitts (R-PA), chairman of the Subcommittee on Health, arguing that the committee should balance well as the adequacy of our post-marketing safety system.”

Especially because that committee is going to be working on reauthorizing the medical device user fee program, the legislators write, it is important for it to consider the safety implications of FDA’s policies, and not just its effects on business. “We believe hearings on these topics would provide important information for members to evaluate in the context of the reauthorization of the medical device user fees,” they write.

“We agree that innovative products that help patients should get on the market quickly,” the representatives conclude, “and we are supportive of the efforts by the administration to improve efficiencies and streamline the approval and clearance process. We are also open to other ways to speed the process. But while working to reduce inefficiencies at FDA, it is critical that we also protect patient safety.”