Democrats in both chambers of Congress have introduced companion legislation that would ensure generic drug companies update their labels if they find new risks or side effects in the same way brand-name manufacturers do.
Current law mandates that generic drug manufacturers use the same Food and Drug Administration-approved labeling for their brand-name counterparts. But while FDA regulations allow brand-name manufacturers to update their labels independently, the same is not true for generic drug makers. Instead, they adopt changes that the brand-name manufacturer has made.
The new joint legislation—called the Patient Safety and Generic Labeling Improvement Act
—addresses the issues involved in the U.S. Supreme Court's decision last year in Pliva v. Mensing, in which the high court ruled that because current federal law doesn't allow generic drug manufacturers to update their labels independently, they cannot be held liable for failing to add or improve their warning labels.
The legislation from Reps. Chris Van Hollen (D-Md.) and Bruce Braley (D-Iowa) in the House, and Sens. Patrick Leahy (D-Vt.), Jeff Bingaman (D-N.M.), Richard Blumenthal (D-Conn.), Sherrod Brown (D-Ohio), Christopher Coons (D-Del.), Al Franken (D-Minn.) and Sheldon Whitehouse (D-R.I.) in the Senate, would authorize generic drug manufacturers to revise their labels using the same processes available to brand-name makers.
“The Institute of Medicine estimates that each year at least 1.5 million preventable drug errors occur in American healthcare facilities, adding an average of $5,000 to the cost of a hospital admission where an error occurs,” Braley said in a news release
. “American patients deserve to have faith in the safety of their prescription drugs, and these types of errors are costing billions of dollars to our healthcare system. Yet, many drug labels still have inaccurate, outdated safety information. This is a dangerous situation for American families, and the Patient Safety and Drug Labeling Improvement Act will fix this problem.”