Proposal Calls for FDA to Change Warning Label Rules for Generic Medications

November 14, 2013

Current federal law states that makers of generic drugs must place the same warning labels on their products as the similar brand name medication; however, the U.S. Food and Drug Administration (FDA) is considering a proposal that would change that regulation. The Philadelphia Drug Injury Lawyers with Lundy Law point out that such reforms may place a greater liability on generic drug manufacturers for injuries caused by their products.

An article from The Wall Street Journal explains that generic drugs make up roughly 84 percent of the medications used to fill prescriptions in the United States today. A ruling issued by the Supreme Court states that manufacturers of these medications do not have the right to change the wording or content of a certain compound’s warning label. The result of the decision is that only brand name drug manufacturers can be held liable for injuries caused by a medication, meaning only an individual taking a brand name drug has a right to hold a drug manufacturer liable for injuries caused by their product.

In response, a proposal has been submitted to the FDA that calls for generic drug makers to have the same ability to change a warning label based on reports of adverse events.

Lundy Law and their team of Philadelphia Personal Injury Lawyers would like to hear the public’s opinion. Should generic drug manufacturers be allowed to change their product’s warning labels from that of the label a similar brand name medication?