The food and drug administration started 2006 with a bang, unveiling a long-anticipated final rule that significantly overhauls
the way drugs and biologics are labeled. This new regulation, designed to improve the communication of risks and benefits,
has been in the works for years, but has been delayed by industry concerns that it could expose companies to more liability
suits. Implementation will be a massive, costly undertaking, but at this point industry has little choice but to comply.
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
in electronic form. That process should finally move ahead now that FDA has eliminated uncertainty about label design. Similarly,
it will now be safer and easier for manufacturers to simplify the brief summary that accompanies print advertising, as FDA
wants: The "highlights" section at the beginning of the new label provides a model for developing briefer and more consumer-friendly
Reducing Research Failures
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
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.