Generic Drug Warning Label Regulations Should be Revised: Public Citizen

The prominent consumer advocacy group Public Citizen has filed a petition urging the FDA to revise regulations that prevent generic drug makers from updating their warning labels to include information about known risks associated with their drugs.

The outdated regulations prevent consumers from learning about many known risks associated with generic drugs and they have been used to shield pharmaceutical companies from product liability lawsuits for failing to warn about dangerous side effects associated with medications they manufacture and sell.

Although brand name drug makers are able to update the warnings and precautions section of their products before getting FDA approval, generic drug makers are not allowed to do so because they are required to have the exact same labeling as the brand-name drug.

Public Citizen filed the petition (PDF) with the FDA on Tuesday, urging the agency to change regulations that prevent generic drug makers from updating their warning labels, even if they know about a risk that is not included on the labeling for the brand-name medication.

This regulation has been used as a defense by many drug makers to argue that they should be immune from liability for failure to warn claims brought by consumers who have suffered serious and sometimes devastating injuries that may have been prevented if adequate information about known risks had been provided on the drug label.

Public Citizen indicates that the changes would help ensure that adequate warnings are provided based on information that is discovered after drugs are approved for marketing, and would bring the regulations in line with the current realities of the pharmaceutical market.

“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 protect patients.”

Earlier this year, the Supreme Court relied on this regulation in support of it’s ruling in Pliva, Inc. v. Mensing, which ruled that generic drug companies can not be held liable for failing to warn about known side effects of medications they sell, so long as their labels are identical to those of the original brand-name product.

The controversial 5-4 decision has had devastating consequences for thousands of individuals who suffered serious injuries after taking generic drugs, leaving them unable to pursue compensation through a personal injury lawsuit even though the generic drug makers may have known that the current warning labels did not adequately warn about the risk.