Sen. Mary Landrieu Examines Mensing Decision, Urges FDA to Offer Consumers Proper Protection

By on March 11, 2013 - Comments off

United States Senator Mary L. Landrieu has drawn attention to and taken a stand for consumer protection in regards to the safety of generic drugs through proper labeling and labeling changes for making side effect risks known. The American Association for Justice (AAJ) worked with Sen. Landrieu’€™s office to complete the letter, which was given to Dr. Margaret Hamburg, the Commissioner of the U.S. Food and Drug Administration (FDA), on February 15, 2013. As consumer advocates, the mass tort lawyers at Robinson Calcagnie Robinson Shapiro Davis, Inc., are pleased with and support Sen. Landrieu’€™s efforts.

One of the main points of the letter highlights that as the regulatory framework exists now per the recent decision by the United States Supreme Court in Pliva, Inc. v. Mensing, consumers are not being offered appropriate protection. The letter urges the FDA to call for new regulations that will concentrate on the problematic aspects of the Mensing decision. Overall, Sen. Landrieu is asking the FDA to allow for generic drug manufacturers to initiate alterations to a drug’s approved labeling through the Changes Being Affected process and Prior Approval Supplement process.

A critical position made by Sen. Landrieu is that while all prescription drugs need to have adequate warnings for their potential risks, this is especially the case for generic drugs, which are more affordable and therefore used in greater quantities than brand-name pharmaceuticals. She also emphasizes that it is often not until a large percentage of sales are made after a drug has entered the market that drug-related hazards reveal themselves. As of now, under Mensing, generic drug manufacturers are not permitted to revise their labels at the time they become aware of a side effect risk.

The Mensing decision takes away any incentive for generic drug manufactures to properly warn consumers of product dangers and also removes a consumer’s ability to hold manufacturers liable for wrongdoing in state court. As such, Sen. Landrieu’€™s letter states, “Any regulatory action taken by the FDA should be crafted in such a way to preserve state tort law based claims against manufacturers.€

According to Sen. Landrieu, it is a combination of the FDA not having enough resources to monitor the thousands of drugs on the market and that the majority of all prescriptions get filled with generic drugs within months of going on the market that puts consumers in harm’s way when using generic drugs.

Related Articles