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Healthcare Group Calls on FDA to Protect Americans


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Healthcare Group Calls on FDA to Protect Americans

While the U.S. Food and Drug Administration has focused on food labeling requirements, one group is calling for it to take a closer look at drugs.

Healthcare advocacy group Public Citizen filed a petition with the federal agency earlier this week urging it to require the manufacturers of generic drugs to update warning labels in order to reflect any new side effects.

Currently, generic drug makers are only able to update their product labeling if they gain FDA approval. This means that when new potential risks of any drug are discovered, they will most likely go unstated on the label.

"Drug safety would benefit if generic manufacturers — who already have access to real-world information about adverse events — could use FDA procedures currently in place for brand-name manufacturers to revise labeling to warn of risks," said Dr. Sidney Wolfe, director of Public Citizen Health Research Group. "Filling this regulatory gap would help to protect patients."

National law firm Ennis & Ennis has come out in support of Public Citizen's efforts, emphasizing that under a new U.S. Supreme Court Ruling that doesn't allow consumers to take legal action against generic manufacturers who fail to list certain side effects on their labels, the cause is that much more important.