Backpage: Warning Letter

This letter concerns the FDA press release dated January 18, 2006, entitled "FDA Announces New Prescription Drug Information Format to Improve Patient Safety." The information contained is considered false and misleading, and lacking in fair balance.

The headline states that this new label format will improve patient safety. In addition, a quote from HHS Secretary Mike Leavitt says the new format "will help ensure safe and optimal use of drugs, which translates into better health outcomes for patients and more efficient delivery of healthcare." We are unaware of any substantial evidence that measures use of drugs or drug outcomes related to the new format.

The new format is described as providing "clear and concise" information to health professionals. We are aware of no evidence that the new format makes information clearer. In fact, the cryptic method of delivering information in the new Highlights section may make information less clear. Professionals may need to look at multiple sections of the label to get desired information.

The release states that by providing "the most important information in a format that is better understood," information will be more accessible and memorable and "have a greater impact" on reducing medication errors. This is a comparable claim (to previous labels) for which there is no substantial evidence. As FDA has consistently stated that knowledge does not necessarily lead to behavior change, we find this statement inconsistent with previous FDA policy. The statement also lacks fair balance. Whenever a system is changed, there is likely to be confusion while people learn to adapt. Therefore, one may postulate that there are likely to be more medication errors made until people learn to use the new format. This possibility is not mentioned.

The Highlights section is not likely to be understood by consumers. The brief messages are unlikely to provide sufficient context for their understanding. Further, the press release suggests the new format will provide "actionable" health information. We know of no aspects of the new label format that will make the information more actionable.

The press release describes the existence of a new Patient Counseling Information section. Drug labels have contained a patient information section within the precautions section. The suggestion that this section is new is false and misleading.

Overall, we find this press release to be false and misleading and lacking in fair balance. The claims made about the usefulness and effectiveness of the new format are unsubstantiated. The explicit and implied comparative statements about the improved communication and behavior changes for the new format are made without adequate substantiation. The usefulness of the format establishes new intended uses for this product that go beyond its labeled indications, for which you have produced no substantial evidence.

Although the information provided in this release is false and misleading, we do not request corrective action. Rather, we suggest FDA gather the evidence necessary to substantiate the claims made. It should evaluate the usefulness of the new format. Previous research has been helpful in the design of the format. However, under FDA risk-management guidance, new interventions must be evaluated and revised based on implementation issues. We suggest such an evaluation for the new format.