Health groups press Congress for deadline on long-delayed FDA regulations

A coalition of healthcare advocates said Monday that Congress should force the Obama administration to issue new regulations on medical devices.

The Advancing Patient Safety Coalition urged lawmakers to address the issue as they work out the differences between the House and Senate versions of a must-pass Food and Drug Administration bill.

Every five years, Congress must reauthorize user fees the FDA collects from drug and device companies. Lawmakers traditionally use the bills to make additional changes to FDA policy.

The last reauthorization, passed in 2007, called for a "unique device identification" (UDI) system to better track devices and monitor potential safety risks. But regulations to implement the UDI have been stuck at the Office of Management and Budget for nearly a year.

The coalition said Congress should set a firm deadline in the current FDA bill. Both chambers have passed their FDA bills, and lawmakers are hoping to send a finished product to President Obama's desk by July 4.

"We believe a UDI system is essential to help protect the safety of patients, reduce medical errors and strengthen the ability of the FDA and manufacturers to monitor adverse events," the coalition said in a letter to House and Senate lawmakers working on the bill. "Every day that goes by without such electronic identification of medical devices is a threat to patient safety and increases costs in the healthcare system."

The coalition includes AARP, the American Medical Association and the Federation of American Hospitals.

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