FDA Rule Could Hold Manufacturers of Generic Drugs Liable For Civil Damages


Proposal by FDA would make manufactures of generic drugs to adhere to same labeling standards as those required by brand-name drug makers.

oxyelite-pro-liver-damage-lawsuitThe U.S. Food and Drug Administration (FDA) has proposed a new rule that would hold makers of generic prescription drugs to the same standard of legal responsibility as brand-name prescription drug makers. The new FDA rule would make generic drug manufacturers abide by the same labeling standards as those required by brand-name drug makers. If the rule is to pass, victims who have been injured by dangerous generic prescription drugs would, for the first time, have the ability to sue the manufacturers of the drugs.

Currently, FDA regulations require manufacturers of generic drugs to maintain drug warning labels similar to those required of brand-name drug makers. The difference, however, is that a brand-name prescription drug maker is able to intensify the strength of its drug warning label when new research emerges, generic drug makers have no such opportunity.

Supreme Court Rulings On Generic Prescription Drugs
The reason for the newly proposed rule is based in legal history at the United States Supreme Court level. A Supreme Court case in 2011 held that an individual has the right to sue a brand-name prescription drug manufacturer for a defect in its labeling when the drug causes injury or death. The maker of a generic prescription drug, however, despite sometimes using the same chemical formation, cannot be held legally responsible.

The Supreme Court has ruled that since companies that manufacture generic prescription drugs do not have the ability to boost their drug warning labels, these companies don’t carry the same level of potential liability in a court of law.

Consumer advocate groups were outraged with the Supreme Court’s decision. In response, these groups pushed the FDA to modify its regulations to provide more protection to those injured or killed by dangerous generic prescription drugs.

New FDA Proposed Rule On Generic Prescription Drugs
The new FDA proposal would provide generic prescription drug manufacturers with the same ability to intensify their drug warning labels in the face of new research as is currently provided to brand-name drug makers. Under the new rule, the FDA would be tasked with the responsibility of reviewing any proposed changes to drug warning labels made by both brand-name and generic manufacturers.

Advocates for the proposed rule are pleased at the focus on patient safety as the federal agency’s top priority. The safety of patients prescribed these drugs, they argue, is the reason to pass these changes.

Generic prescription drugs account for 80% of all prescription drugs dispensed in the United States every year and create more than $200 billion each year in cost savings to the U.S. healthcare system. Those opposed to the FDA proposal cite concerns about driving up the costs of generics as a result of the increased labeling requirements.

Before it can be made final, the proposed rule must pass through a 60-day comment period. If the rule is to pass, those who have been injured as a result of generic prescription drugs will have a new ability to recover civil damages for their injuries. Consultation with an experienced attorney is highly recommended.


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