FDA Ruling Will Make Generic Drug Makers Disclose All Health Risks

A proposed new federal rule would close a legal loophole that has protected generic drug manufacturers from personal injury and wrongful death lawsuits due to undeclared side effects.

“In the current marketplace, approximately 80% of drugs dispensed are generic drugs,” the FDA said according to The Los Angeles Times. “Accordingly, there is a need for [generic drug producers] to able to independently update product labeling to reflect certain newly acquired safety information.”

In 2009, the Supreme Court ruled that pharmaceutical manufacturers could be sued for personal injury or wrongful death if the side effects caused serious harm to the consumer. However, because generic drugs are made with the same active ingredient, until now they could only declare the same side effects as their brand name counterpart, and the Supreme Court considered that they were therefore not liable for undeclared side effects because they could not change their labels.

“Now, with the generic industry having grown up, most people are taking generic drugs,” said Dr. Janet Woodcock, the F.D.A.’s head of drug evaluation and research, in a telephone interview. “It’s really time to level the playing field.”

In November 2013, the FDA proposed to change that – generic drug makers would have more control over their labels, but they would also become liable for undeclared side effects.

The proposal could also hold generic drug manufacturers to many of the same safety testing standards as their brand name counterparts. Although problems related to active ingredients are known by the time the brand name drug loses its patent, side effects related to size of dose or inactive ingredients in the generic version are unknown.

The president of the Generic Pharmaceutical Association Ralph G. Neas stated that his group would fight these new regulations. “Our aim is to get the facts out there,” he said. “This will go for some time. I don’t believe this [proposed] rule benefits anyone in the healthcare system.”

Mr. Neas also raised the question of whether the rule was legal. “The Supreme Court has repeatedly held that generic pharmaceutical manufacturers must duplicate the language on the brand pharmaceutical manufacturer’s labels and cannot make changes to a label without F.D.A. approval,” he said in the statement. “Therefore, the agency’s authority to enact a rule that differs from the federal law is unclear.”

The Strom Law Firm Can Help with Personal Injury Lawsuits Against Dangerous Brand Name or Generic Drugs

At the Strom Law Firm, LLC, our personal injury lawyers understand that your case, your story, is about more than just an accident or physical injury.

It is also about what happened after the accident or injury. It’s about how that accident and those injuries have affected you and your life, and about how they may keep on affecting you in the foreseeable future. It’s about before and after.

As your personal injury attorneys, you can depend not just on our knowledge and understanding of the law, our resources, and our proven ability to secure positive results in personal injury cases. You can depend upon our commitment to telling your story and to securing fair compensation for all the ways you have been affected and will continue to be affected in the future.

If you have been harmed, or a loved one has been harmed or killed, by a defective product or drug, the attorneys at the Strom Law Firm can help. You may be entitled to compensation through a personal injury lawsuit. We offer free, confidential consultations to discuss the facts of your case, so contact us today. 803.252.4800.