FDA Rx labeling clarified

April 1, 2009

Widespread confusion about the new label format for prescription drugs has sent FDA officials to association meetings around the country, explanations in hand.

Key Points

"[The] drugs that the Food and Drug Administration [approves] are getting more complex," Denise Cook, MD, senior reviewer in the Division of Dermatology and Dental Products (DDDP) at FDA's Center for Drug Evaluation and Research, told participants at the American Academy of Diabetes annual meeting held in San Francisco. "That is why drug labeling was getting more complex and harder to use. We had a mandate to make labeling more informative, more accessible, and easier to use."

Authority for a new product label format is part of the Food and Drug Administration Amendments Act of 2007 (FDAAA), said DDDP chief Susan Walker, MD. The new label is the latest step in the evolution of FDA responsibility and authority that began when drug safety requirements were introduced in 1938. FDAAA gave the agency new mandates to improve drug safety, including changes to labeling.

One of the key changes is responsibility for label content. Under the old rules, manufacturers wrote drug labels and FDA approved the content. FDA reviewers could request changes, but drugmakers were under no compulsion to comply. "If changes were necessary, we had to negotiate with manufacturers to get the best wording possible," Walker said. "Now we can require labeling changes to be made, and we can require the form those changes will take." One of those required changes is a standard format. The familiar old-style package insert contains different subject headings that can appear in a different order on each product. Labeling information is typically printed in small font that can be difficult to read without magnification, Cook said.

The most obvious part of the format change is the new half-page highlight section, which provides a snapshot of key information from other sections of the label. The new format is based on user research revealing that providers most often use drug labeling to look for specific topics or items of interest.

Clinicians in focus groups told the FDA that it was hard to find specific information on the old narrative-style label. Providers also said they would read and use the label more frequently if it contained a short synopsis.

The new highlights section must include a concise summary of the scientific information needed for safe and effective use of the agent, including any black box warnings, Cook said. The highlights section must be updated whenever new information becomes available that makes the current label inaccurate, false, or misleading. The FDA can also require changes if any items the agency deems to be important have been omitted.

Typical entries include the drug name and formulation, date of initial U.S. approval, any black box warnings, recent major changes to labeling, indication and usage, dosage and administration, dosage forms and strengths, contraindications, warnings and precautions, adverse reactions, where to report suspected adverse reactions, drug interactions, and uses in specific populations.

FDA hopes that detailed information on reporting suspected adverse reactions will bolster the MedWatch reporting system, said Jill Lindstrom, MD, chief medical officer for DDDP. Every label will include telephone and Web site information for the drugmaker and the FDA. The MedWatch number is 1-800-FDA-1088; the website URL is http://www.fda.gov/medwatch/. Entries in the highlight section must be referenced to specific headings and sections in the full prescribing information. When the label is presented in electronic form, highlight references must be hyperlinked to the appropriate section in the full prescribing information. "The highlight section does not include all of the information you need to use the drug," Cook cautioned. "You still need to read the entire label."