Three U.S. senators have fired off investigative letters to 5 devicemakers seeking information on how the companies conduct post-market surveillance, as well as on how they manage recalls when a product is pulled from the market. The senators also have introduced a bill they say aims to protect patients from unsafe medical devices and improve the management of recalls.
Sens. Chuck Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI) sent the letters to Johnson & Johnson ($JNJ) for its DePuy metal-on-metal hip implant; Medtronic ($MDT) for its Infuse product; Boston Scientific ($BSX) for Guidant's defibrillators; CR Bard ($BCR) for vaginal and hernia mesh products; and Zimmer Holdings for its knee replacements.
The recalls have been a hot topic as of late, subjects of Senate committee hearings and news reports. This year, for example, the Senate Special Committee on Aging held a hearing titled "A Delicate Balance: FDA and the Reform of the Medical Device Process." The panel examined the FDA's role in protecting patient safety as part of the medical device approval process and featured Katie Korgaokar, a Denver resident who received a DePuy ASR hip implant. She was one of the more than 90,000 patients affected by the DePuy hip implant recall.
Medtronic's Infuse, a product designed to spur bone growth, has been the target of scientific journal articles that allege its side effects were downplayed or omitted in scientific articles by researchers with financial ties to the devicemaker. Grassley and Sen. Max Baucus (D-MT) sent a letter to Medtronic CEO Omar Ishrak asking for more information about these financial relationships. A Medtronic spokesman said the company has received the newest congressional missive and is "working to comply with their request," as quoted by the Minneapolis Star-Tribune.
The three lawmakers have also introduced a bill, called the Medical Device Patient Safety Act, that would give the FDA the improved ability to discover problems with faulty medical devices sooner and to better manage recalls when problems do occur--all without slowing down the approval process.
The bill would allow the FDA to require post-market clinical studies for medical devices that pose potential safety risks if they were approved through the expedited 510(k) review process.
This isn't the first time Grassley and Kohl have addressed the topic of device recalls. In June, the duo released a GAO report that determined that the FDA hasn't routinely analyzed data to determine whether there are systemic problems underlying trends in device recalls, thus missing out on a chance to use the information to address the risks presented by unsafe devices. The new legislation implements some of the GAO's recommendations for improving recalls and gives the FDA new authority to require conditional clearance-pending safety studies.
"This reform legislation should be part of the reauthorization of the medical device user fee law next year," Grassley said. "The reforms incorporate well-founded recommendations from the Government Accountability Office and reflect the value of having a robust post-market surveillance operation in the FDA. Important information can be learned about product safety after a device is on the market, and when there are problems, the sooner the response, the better."
But at least one medical device industry group has expressed reservations about the bill. "AdvaMed shares Sens. Grassley, Kohl and Blumenthal's interest in ensuring American patients continue to have access to safe and effective medical devices" Janet Trunzo, AdvaMed's executive VP of technology and regulatory affairs, said in a statement. However, "We believe expanding the FDA's authority to require post-market studies as a condition of 510(k) clearance is unnecessary given the agency already has broad authority to require manufacturers to conduct post-market studies for higher-risk devices cleared via 510(k)."
- see the lawmakers' statement
- read AdvaMed's response
- check out more from the Star-Tribune