The first redesign in 25 years of the prescription drug “package insert” by the US Food and Drug Administration (FDA) should make it easier for physicians to understand vital pharmacological information. But the new label rule also may make it more difficult for patients and lawyers to sue pharmaceutical manufacturers for product liability.
Citing research showing that prioritizing warning information has an impact on reducing preventable adverse medical events, the FDA at a January 18 press conference said the newly designed package insert will provide the most important information about a prescription product in a format that should improve comprehension by physicians. The new insert will appear beginning June 30 with newly approved drugs, and all drugs approved within the past 5 years will gradually be converted to the new insert format.
Mitka M. Drug Package Inserts Get Mixed Reception. JAMA. 2006;295(10):1110-1111. doi:10.1001/jama.295.10.1110