By: Jeff S. Gibson, Attorney
In November, the FDA announced it would begin the process of changing its rules to allow generic drug manufacturers the ability to update product labels with safety warnings and new information. This action follows much debate about the responsibility of generic drug manufacturers in patient-safety matters.
Two recent U.S. Supreme Court rulings PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co., Inc. v. Bartlett held that state law failure-to-warn claims and state law design-defect claims against generic drug manufacturers respectively were preempted by the federal requirement that generic drug labels and warnings be identical to the brand name counterparts.
The requirement that generic drug labels be identical to the branded drug stems from the FDA’s approval process for generic drugs. Because generic drugs have the same active ingredient, strength, and dosage form as their brand name counterparts, the agency requires that labeling be identical. The intent is to reduce confusion in the administration of generic drugs. However, this rule places consumers at a higher safety risk.
Consumer Risks and Safety
Because of the current regulation governing generic drug labeling—that the generic label match the brand name label– if the FDA discovers a large number of adverse events are being reported associated with a particular generic medication, the manufacturer of that drug cannot change its label to reflect this danger. Compare that to the opposite situation.
If a large number of adverse events were reported with a brand name drug, that manufacturer would have the ability to change the safety label to warn patients and doctors. The change to the branded drug label would trigger the necessary change to the generic drug label. Given the fact that 80% of the prescriptions filled in the U.S. are generic drugs, the current regulation places consumers at a higher patient-safety risk.
From a consumer safety standpoint, this proposed change can have a positive impact on the quality of healthcare for millions of Americans. From a legal standpoint, it allows consumers to hold generic drug manufacturers accountable for the safety of the products sold on the market.
A 60-day comment period is open to the public regarding this proposed rule change. In mid-January 2014, the FDA will move forward with its proposal. More information about this rule change can be found on the agency’s website.
If a person suffers a serious injury as a result of taking a dangerous drug, there are legal remedies they can pursue regardless of whether the drug in question is a branded or generic medication. A knowledgeable product liability attorney can evaluate the claim and explain your legal rights and options.