Following the massive DePuy hip replacement recall, Senators Charles Grassley (R-Iowa), Richard Blumenthal (D-Conn.) and Herb Kohl (D-Wis.) have introduced legislation to help protect patients from being exposed to dangerous medical devices and to ensure that recalls are conducted promptly when a company learns that a device is defective.
This bipartisan bill authorizes the FDA to require post-market clinical studies for medical devices such as hip implants, that could have serious safety risks. The bill also gives the FDA the ability to require manufacturers to conduct safety studies after a device is approved through the expedited 510(k) process, the regulatory loophole that allowed the DePuy ASR to be sold in the United States.
“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.”
“Unsafe medical devices pose severe dangers to patients and impede approval of new, safe devices – causing significant costs to our economy as well as health,” said Blumenthal. “This bill will help protect people from dangerous unsafe medical devices by demanding more consumer safeguards, improving recall management, avoiding costly recalls, and preventing irreversible injury to patients. By removing unsafe devices from the market more quickly and efficiently, we’re preserving a faster approval track for safe and effective products to reach patients.”
“Faulty medical devices, especially those implanted in the body, can have disastrous health impacts on patients,” Kohl said. “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.”
The three Senators also sent investigative letters to five companies, including Johnson & Johnson / DePuy. The Senators have requested details about DePuy’s post-market surveilance of the ASR implant, and how and when it decided to recall the ASR from the market. The letter said:
As the Special Committee on Aging’s recent oversight hearing detailed, effective post-marketing surveillance practices allow companies to recognize problems with medical devices in a timely fashion, preventing expensive recalls later, and can also save lives and prevent unnecessary suffering.