Legislation Would Change Generic Drug Labeling Rules

Congressional Democrats just introduced joint legislation to change generic drug labeling rules when new risks or side effects are discovered. This is currently done for brand-name medications.

Today’s law mandates generic drug makers use the U.S. Food & Drug Administration (FDA)-approved labeling that brand-name drug makers use when updating their medications’ labels, said Modern Healthcare. FDA regulations permit brand-name manufacturers to update labeling independently; however generic drug makers take on changes used by the brand-name manufacturer.

The legislation, released by both chambers of Congress, is entitled the “Patient Safety and Generic Labeling Improvement Act.” The Act covers issues that were part of last year’s U.S. Supreme Court’s decision in Pliva v. Mensing. The high court ruled in that case that because current federal law does not permit generic drug manufacturers to independently update their labels that they cannot be held liable for not adding or improving generic warning labels, explained Modern Healthcare.

The legislation, submitted by Democratic House Representatives Chris Van Hollen (Maryland) and Bruce Braley (Iowa) and Democratic Senators Patrick Leahy (Vermont), Jeff Bingaman (New Mexico), Richard Blumenthal (Connecticut), Sherrod Brown (Ohio), Christopher Coons (Delaware), Al Franken (Minnesota) and Sheldon Whitehouse (Rhode Island), is meant to allow generic drug manufacturers to revise drug labeling utilizing the same processes used by brand-name makers, said Modern Healthcare.

“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,” Representative 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 Yet, many drug labels still have inaccurate, outdated safety information.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,” he added, said Modern Healthcare.

We recently wrote about last year’s Supreme Court ruling barred the public from suing makers of generic prescription drugs over side effects caused by their medications. Supreme Court justices ruled that, because the makers of the name-brand prescription drug also write the safety information included with the drug, they are legally responsible for any damages or side effects linked to the drugs. Generic drug makers are forced to adopt the safety information as written by the previous company and include it with their version of the drug.

The issue with this decision is that it could eventually leave millions of Americans without legal options should they suffer side effects caused by generic drugs. Only patients who purchased the name brand versions would be able to explore legal options.

The New York Times recently reported that since that Supreme Court ruling, at least 40 judges nationwide have rejected lawsuits filed against the generic drug makers. Some judges have reportedly dismissed “dozens” of cases consolidated in their courts.

Of note, makers of generic drugs are exempt from pursuing the same premarket safety testing of their version of name-brand drugs because of a 1984 law which mandates that if a generic maker pursued this path to the market, it would must also adopt the safety information as distributed by the makers of the name-brand alternative. To qualify for these exemptions, generics makers must prove their version of a drug is identical to the name brand.