Meeting regulatory requirements and safety standards is only half of the battle for OTC drug manufacturers. As FDA's Kubaska
points out, "Like prescription drugs, OTC drugs can cause serious adverse events." And the fact that there is no healthcare
provider between a consumer and an OTC drug means that "the consumer must be able to self-diagnose the condition and safely
self-medicate," explains Kubaska. For this reason, OTC product labels and information leaflets must be even more clearly identifiable,
readable, and understandable to the average consumer than those for prescriptions.
According to David C. Spangler, senior vice-president of policy, and general counsel and secretary for CHPA, "the labeling
standards that we have today [for OTCs] have been gone over in painstaking detail by FDA. When putting together a category
monograph, the biggest thing FDA is focusing on, in addition to effectiveness and safety of the ingredients, is getting the
labeling right. There is always room for improvement, but labeling reviews have been going on for decades."
In terms of improvement, in August 2010, FDA released an OTC guidance for industry on label-comprehension studies (5). These
studies determine how well a consumer can read and understand a label. "FDA felt the need to publish this guidance to help
industry conduct well-designed studies that provide meaningful data," says Kubaska. Although the guidance is not expected
to require major changes in industry practice, it demonstrates that regulators are concerned about making sure OTC manufacturers
provide the most clear and accurate information to consumers.
The guidance targets companies planning a label-comprehension study to evaluate a new label or a labeling change, but also
applies to drug sponsors trying to switch their already approved prescription drugs to nonprescription status, a trend that
seems to be on the rise, says CHPA's Spangler. (See a list of prescription to nonprescription switches at http://chpa-info.org/media/resources/r_4620.pdf.) This type of marketing switch has to be done extremely carefully, not just from a manufacturing and business perspective,
but also from the consumer's perspective.
Caution is especially important when considering a complex drug status switch, such as those for cholesterol-lowering products.
According to Spangler, these types of status switches involve intense labeling reviews because the products they are based
on are generally for asymptomatic conditions. Without obvious symptoms, it is more difficult for a consumer to self-diagnose
and self-treat, and so the product labels must be extremely detailed. "We are already seeing this type of switching activity
in the UK, and it's more likely for the US in the future."
Across the Atlantic, the European Medicines Agency (EMA) is taking another look at OTC product labels as well. In April 2011,
the agency released quality review recommendations for nonprescription-drug packaging design and labeling that would apply
across the European Union (6). The new recommendations add to already existing requirements in the European Commission's Directive
2001/83/EC and in the 2009 EMA guideline on the readability of the labeling and package leaflet of medicinal products for
human use (7). The new document aims to better harmonize OTC labels across Europe, especially where certain descriptions may
use symbols or pictograms. Fonts, colors, text size, and information to be included on the labels and leaflets are addressed.
Comments on the recommendations are due to EMA by June 30, 2011.