This final decision on the format and content of professional labeling sets the stage for FDA to move forward with other initiatives. For example, the agency recently required manufacturers to submit all labeling
Although the basic framework of the new labeling rule surprised no one, compliance will require significant investment by manufacturers. To meet the new design and content requirements, most professional labels (also known as "package inserts") will be twice as long, requiring manufacturers to change packaging lines and label printing operations for many products. FDA agreed to keep type fonts fairly small, but many new labels will need an additional page, which represents a big expenditure.
The most significant change is the new highlights section, which summarizes a product's most important prescribing information, including boxed warnings, approved uses, recommended doses, warnings, and adverse events. (Links to the new rule, agency guidances, sample labels, and guides for consumers and healthcare providers are available at http://www.fda.gov/cder/regulatory/physLabel/default.htm).
The new label includes a table of contents, offering a guide to full prescribing information. Overall, the new label gives more prominence to safety issues, such as drug-drug interactions and prescribing limits, and shifts more technical sections to the bottom. All labels now will include clinical trial results and toxicology data, and a concluding Patient Counseling Information section, which will reiterate the most important uses and limitations of the medication in order to help physicians discuss risks with patients. Any FDA-approved patient information or MedGuide has to accompany the full label or be added on at the end.
Of interest to marketers is the provision requiring labels to include the results of clinical trials. In a separate guidance FDA explains that it is looking for information on effectiveness drawn from well-controlled studies—and not data on unapproved uses or unsubstantiated comparative claims. FDA seeks consistent data for product classes and indications, as well as across drug classes, to establish a clear basis for promotional claims by competitive products.
The agency is phasing in compliance with the requirements, starting with new drugs and eventually covering all products approved within the last five years and older products making important label changes. Although most older drugs will not be required to adopt the new format, FDA hopes that many will do so.
While the highlights section may be useful to prescribers and patients, pharma companies worry that this format will expose them to liability suits from individuals who suffer adverse events that are not highlighted but "hidden" in the full prescribing information. Industry also fears that a dual-label system will generate claims that products with old labels fail to adequately warn of safety issues.