OTC manufacturers label pending FDA regulations as positive

Drug Store News, Dec 9, 1996

WASHINGTON, D.C. - New labeling requirements that will dramatically change the appearance of nonprescription drug labels may soon be released by the Food and Drug Administration.

FDA representatives and senior OTC manufacturer executives attending the Nonprescription Drug Manufacturer Association's Annual Research and Scientific development conference hinted that the sweeping new rules may be released by the end of the year.

"Rumor has it that we can expect a proposal back this year, and we are optimistic that we are near a resolution," said Tom Laughlin, senior vice president worldwide of Pharmacia & Upjohn Consumer Healthcare, and chairman of NDMA.

Uniform headings

Tempering Laughlin's optimism was Sharon Smith Holston, the FDA's deputy commissioner for external affairs. She didn't specify when the new rules will be released. However, her public comments indicated that the FDA is thinking along the same lines as manufacturers, and her comments were well received by NDMA members.

"You can safely assume that we will pay close attention to the suggestions that were presented by your representatives at our hearing last year and to the very well thought out comments that were submitted by NDMA," Holston said.

"What are some of the requirements for a useful and effective product label?" Holston asked. "Our experience with the food label indicates that the consumer responds best to uniform headings and subheadings, especially if they are presented in a standardized format. Uniform typefaces and legible type sizes, adequate spacing between words and lines and other graphical features are also very important for consumer comprehension."

She went on to add that "terse and simple statements in a bullet format are much more readily understandable than long sentences, with arcane scientific terms, that are usually meaningless to the typical lay person." According to Holston, "much needs to be done to replace the great variety of current labeling designs with an eye-catching, standardized format in a legible, clear informative text that is couched in comprehensible language."

OTC manufacturers support the changes mentioned by Holston, and were relieved that the FDA doesn't plan to tinker with what is known as the product's principal display panel. Manufacturers were staunchly opposed to early proposals, which would have required that a product's active ingredients be listed on the front of the package.

OTC manufacturers recognize that product labels have room for improvement. They also realize the important role that label comprehension and actual use studies play in persuading the FDA to grant marketing clearance on Rx-to-OTC switches. Since most switch applications have an established track record of safety and efficacy, whether they are switched or not boils down to a determination of whether consumers are able to self-diagnose the ailment that the drug treats, and can responsibly use the product without the supervision of a health professional.

The legibility and comprehension of product labels can make the difference on a switch, because the FDA has moved toward requiring manufacturers to perform what are referred to as actual use studies. Those studies reveal whether consumers are capable of obtaining the desired relief from a proposed switch product when they use it in an unsupervised environment, as opposed to a closely supervised clinical trial.

The FDA appears to be in favor of giving consumers the benefit of the doubt when it comes to self-medicating, but wants to make sure communication on the product label is understandable.

"We have to design a new OTC label that will truly communicate," Holston said. "We need to make sure that the labeling actually speaks to the consumer, and delivers the message that will help consumers choose products that are best suited for their needs and use them in a way that is best for their health."

Labels a priority

Issuing the proposed rules has been identified as a top priority for Debra Bowen, director of the division of over-the-counter drug products in the FDA's Center for Drug Evaluation and Research. Industry sources said, however, that once the rules are published, a 60- to 90-day comment period is likely. After that, the FDA will digest any further input before issuing a final rule.

Even after a final rule is published, manufacturers will probably seek at least a two-year period to bring product labels into compliance. In reality, consumers will notice gradual changes to product labels as manufacturers begin implementing the new requirements when new production cycles begin. Implementing the new label guidelines may also be a competitive advantage, since they will be easily to read.

The OTC label reform owes much to a similar reform the food industry underwent 15 years ago. According to Holston, food labels hadn't changed during that 15-year period, but nutrition science had advanced greatly, and consumers wanted more information about the products they were consuming.