MASSDEVICE ON CALL — A quartet Senators yesterday introduced the bi-partisan Ensuring Safe Medical Devices for Patients Act, in the latest legislative effort to beef up the FDA’s oversight of medical devices.
Sens. Jeff Merkley (D-Ore.), Chuck Grassley (R-Iowa), Michael Bennet (D-Colo.) and Herb Kohl (D-Wisc.) lent their names to the measure and won the backing of a clutch of advocacy groups.
"Faulty medical devices, especially those implanted in the body, can have a disastrous impact on the health of those who use them," Kohl said in prepared remarks. "Innovative technology has provided valuable, life-saving medical devices that have prolonged life and reduced suffering, but the drive toward getting new technologies to market shouldn’t be done at the risk of patient safety. This legislation will help achieve that needed and delicate balance between safety and innovation."
The bill would force the FDA to issue a final rule before the end 2012 on the Unique Device Identifer program, created nearly 5 years ago to enable tracking of medical implants, and add medical devcies to the Sentinel post-market surveillance initiative, a 2008 program that currently monitors prescription drug safety.
The legislators pointed to the slate of recent high-profile medical device recalls as evidence that the FDA needs more oversight in ensuring public safety.
"When seniors undergo hip replacement surgery or heart patients need a cardiac stent, they shouldn’t have to worry that the device that is supposed to improve their health could actually make them sicker," Merkley said in prepared remarks. "Strong post-marketing surveillance of medical devices will ensure that those that are defective or cause harm can be quickly identified, patients and their physicians can be notified, and dangerous products can be removed from the market."
Grassley and Kohl are no strangers to medical devices and the FDA. The duo released a report in June 2011 detailing the shortcomings of the federal watchdog agency’s system for reviewing and monitoring recalls, calling for more proactive oversight of recalls and enhanced review of trends.
That same month, Grassley and Sen. Max Baucus (D-Mont.) told Medtronic Inc. (NYSE:MDT) to fork over documents relating to an ongoing investigation into the company’s controversial Infuse bone-growth system.
The Grassley and Kohl were joined in December 2011 by Sen. Richard Blumenthal (D-Conn.) in introducing the Medical Device Patient Safety Act, which aimed to beef up the FDA’s safety regulations, allowing the agency to conduct safety studies of devices after they’ve been approved and to grant conditional approvals contingent on further trials.
Last month Grassley launched an investigation into whistleblowers’ claims that the FDA systematically persecuted and spied on employees who voiced concerns over certain medical devices cleared for the U.S. market.
The newest bill was endorsed by advocacy groups Consumers Union, the National Women’s Health Network, the National Research Center for Women & Families, the Health Care Supply Chain Assn., the Premier Healthcare Alliance, the Assn. of American Medical Colleges, the Alliance for Advancing Nonprofit Health Care, the National Assn. for Continence, the MedicAlert Foundation, Public Citizen and the Union of Concerned Scientists.
