New FDA drug labeling changes

A New England Journal of Medicine perspective piece (Avorn J, Shrank W; NEJM 2006 Jun 8; 354:2409-11),Highlights and a Hidden Hazard — The FDA's New Labeling Regulations, discusses the new FDA drug labeling rules that are going into effect later this month. The article notes that a new "highlights" section on the label and a web-based compendium of the better-organized labeling information may prove useful for some users but comments that the potential for significant consumer behavior change seems unlikely given the fairly conservative nature of the changes. The authors also point out that the new rules give little assistance to prescribers.

The new labeling regulations also contain a section limiting drug companies' legal liability for harm caused by their pharmaceuticals. Avorn and Shrank note, "Beginning at the end of this month, the new regulations would preempt nearly all action by patients in state courts against drug manufacturers for unanticipated injuries resulting from the use of their products. This immunity would apply even if a company failed to warn prescribers or patients adequately about a known risk, unless a patient could prove that the company intentionally committed fraud — a very hard test to meet...[T]he changes the FDA will begin implementing next month include a regulatory time bomb that could severely limit the accountability of companies that fail to adequately evaluate or report the risks associated with their products."

The full text of the final rule and the pending changes are available on the Food and Drug Administration site: New requirements for prescribing information.