New Drug Makers’ Labeling Could Limit Product Liability

Beginning June 30, drug manufacturers will be required by the Food and Drug Administration to provide more concise and better organized patient information package insert sheets.

Any drug approved within the last five years will have new requirements implemented gradually over the next seven years.

The inserts will feature a table of contents, a toll-free number to encourage reporting of adverse drug events, the initial date of FDA product approval, and a section called “Highlights” that will summarize some of the most important drug information including benefits, risks, and usage.

New evidence related to the drugs will be updated and available online free of cost to healthcare professionals and consumers at http://dailymed.nlm.nih.gov.

Dr. Dominick Trombetta, assistant professor of pharmacy practice at Wilkes University in Wilkes-Barre, Pa., says that consumers and doctors may benefit from the new rules because drug information will be more user-friendly, consequently minimizing adverse drug reactions and medication errors. “Research has demonstrated that providing a prioritization of prescribing information can possible reduce medication related problems,” he says.

Dr. Trombetta believes this is a positive step in improving medication use, but has concerns about the current label changes that will make it more difficult to sue drug manufacturers over product liability. “FDA’s response to drug manufacturer’s concerns over increased liability was to include wording that would exempt them from state product liability,” a decision that Trombetta anticipates will be challenged in court.

The adequacy of information provided in the information sheets to healthcare professionals and to patients has recently been a source of class-action lawsuits over drugs such as Vioxx, Bextra, and Propulsid, making drug manufacturers reluctant to make changes to the information they provide. “The FDA’s response to manufacturer’s concerns was to include wording that would exempt them from state product liability,” says Dr. Trombetta.

Though Dr. Trombetta believes the FDA’s new rules are a positive step in improving medication use if fully utilized, he calls the limitations on product liability “extremely disturbing.”