Medical Device Link.

Originally Published PMPN February 2002

PHARMACEUTICAL

Manufacturers find innovative ways to accommodate FDA's Drug Facts panel.

Erik Swain, Senior Editor

It has been three years since FDA mandated a new labeling format to enhance the readability of labeling for over-the-counter (OTC) drugs. The majority of OTC drug products have to display the new Drug Facts box by May 16, 2002, which means it is almost time for most OTC drugs to come into compliance.

The ways in which OTC drug manufacturers have met or are planning to meet this requirement are diverse, and the packaging and labeling suppliers who have stepped up to offer products and services to address the issue have benefited.

MINOR CHANGES FOR MOST

Most OTC drug packages, it appears, have needed nothing more than redesigned graphics in order to meet the requirement. "A majority—probably a substantial majority—of products have been able to fit in the new format without major changes," says William W. Bradley, vice president–technical affairs for the Consumer Healthcare Products Association (CHPA; Washington), which represents OTC drug manufacturers. "A number of [manufacturers of] smaller packages did have to do something different, however."

Some drug manufacturers are sacrificing logos and graphics so that they won't have to make extensive changes to the package or label, hoping this will not have a negative effect on shelf presence.

"We have seen customers give up a lot of graphical space on a lot of panels," says Tim Freeze, manager of products, solutions, and systems for Mebane Packaging, a Westvaco Packaging Resource (Mebane, NC). "A small analgesic, for example, may have the Drug Facts on every panel except the face. They are condensing and fitting around existing packaging as much as possible, and a good number of them have been able to pull it off without any changes [other than to the graphics.]"

Even in cases where only graphics changes are needed, drug firms are turning to packaging and labeling suppliers for help because of the sheer number of SKUs involved, says Phil Naidrich, national accounts manager for Impaxx Eastern USA (South Plainfield, NJ). "Most products have multiple counts, which means everything needs to be changed down the line," he says. "That may mean a firm could have hundreds, maybe even thousands, of SKUs to change, which may cause a burden to their graphics department. So companies like us can assist with their design capabilities."

The graphics-only change can have drawbacks, however, Freeze notes. "You might walk into a store and notice a product with an EAS (electronic article surveillance) tag covering the face panel, but the other panels are all taken up by Drug Facts. That means they have basically given up all product recognition on the shelf."

Therefore, some manufacturers have opted to make significant changes to the package or label, and often they are looking at the changes as an opportunity to make a positive marketing impact, suppliers say.

THE CASE FOR BIG CHANGES

"Marketers are taking advantage of the opportunity to update their packages," says Howard Thau, president of Sonic Packaging Industries Inc. (Westwood, NJ). "Even if they don't need to totally revamp the package, they are taking the opportunity to update their graphics or add a folding carton or other secondary package. If they had not been forced to do it, would they do it? Probably not. But since they have to, they are looking to maximize what they are getting for their dollar."

Some firms are even using the changes to address the structure of their overall packaging operations, says Neil Sellars, director of product development and marketing for National Label Co. (Lafayette Hill, PA).

"It is a good time to consider issues like source package reduction, where it might be prudent to get rid of secondary packaging, redesign the container, and adopt multipanel label technology," he says. "It may also be a time to justify buying new labeling equipment, which will place fewer limitations on productivity and reduce product costs in the long run. Firms should be thinking how they can turn the situation into something perceived as positive by the consumer."

While some of the changes have been expensive, many firms appear to have found a way to keep costs related to the regulation from spiraling. Bradley says that while his organization has not done a cost survey recently, the cost of the regulation to industry looks to be less than what CHPA had projected, albeit more than FDA's estimates.

SOLUTIONS

One of the most common solutions has been to add a folding carton to a product that did not previously have one, or to move to a carton with an extended panel for more space.

For example, Diamond Packaging's (Rochester, NY) Design Relief packaging line includes one carton with a foldout panel that fastens to the outside of the carton but can be opened by consumers to reveal the Drug Facts, and another with a pull-tab panel that extends to reveal the Drug Facts or promotional content.

"These don't damage the integrity of the carton at all," says Lisa Palvino, Diamond's director of marketing. "You don't have to open the package to see the information, and it doesn't take up more room on the store shelf."

Cartons with raised panels for hanging displays have come into favor for very small packages such as antacids previously rolled in paper and foil. However, some in the industry expect a few products that were in tiny packages to be discontinued, as manufacturers decide a totally new packaging system is not worth the expense. FDA says it is reviewing a citizen petition from Lil' Drug Store Products Inc. (Cedar Rapids, IA) regarding such products and notes that their manufacturers can apply for an exemption.

RJR Packaging and McNeil Consumer & Specialty Pharmaceuticals devised a pouch with flaps that open to reveal the Drug Facts information.

Another solution for small packages is a pouch designed by RJR Packaging (Winston-Salem, NC) and McNeil Consumer & Specialty Pharmaceuticals (Fort Washington, PA), a Johnson & Johnson company, featuring flaps attached to the pouch that open up to reveal Drug Facts and then can be resealed to the side of the pouch. It can be produced at the same speed and with the same tools as regular pouches.

Some products packaged in bottles without cartons have adopted expanded content labels (ECLs), which come in many different forms.

"Most times the issue can be resolved with the inclusion of a panel on the adhesive side of the label," says Des Laffan, general manager of Pharmalabel (Greensboro, NC), a John Henry Packaging Group company and a member of the RxPerts printing alliance. "This does not cost as much as multipanel or multi-ply labels. In many cases, reasonably priced solutions can be run without heavy make-ready requirements or special equipment."

Other examples include Reveal Estate from Impaxx and the 700 Degree series from National Label. With Reveal Estate, "the label wraps around the bottle, and then you take a thumb notch or pull-tab and pull to reveal additional text on the back of the pulled-out label area," says Naidrich. One version of the 700 Degree series, also a wraparound label, includes a tamper-evident band within the primary label, Sellars says.

One thing to be aware of with adhesive-side printed ECLs, Laffan says, is the potential for the adhesive to flow or migrate, taking the copy with it. "On our Text-A-Peel ECLs, we work with the most stable adhesives and the proper UV adhesive deadeners. We've done a tremendous amount of testing to guard against ink migration. We're very concerned about the level of testing that is performed by the printed-packaging suppliers as well as by the end-users. Opportunity exists for failures to be discovered in the field in the coming years if we're not all careful."

Those who use a bottle and a carton have been faced with another decision: whether to put the new format on the bottle and the carton or just the carton. FDA recommends that the Drug Facts format be placed on both primary and secondary packaging but only requires that it be visible to the consumer at the point of purchase. Some firms have opted to save costs by converting only the carton, while others have chosen to convert both on the grounds that the carton will likely be thrown out once the product is taken home, and the consumer will rely on the bottle's label when it is time to take the medication. "The [companies that change] both are more forward thinking," Sellars says. "Just doing the secondary packaging follows the letter of the law but may not be as helpful to the consumer."

Blisters have also been targeted by the new rule, Freeze says. "Some customers are changing from small containers to a face-sealed blister card so all of the Drug Facts information can be on the back of the blister card," he says.

Other manufacturers, Freeze notes, have increased "copacking" promotions, in which two brands or two sizes are bundled together. A die-cut card with the Drug Facts information might be placed under the shrink wrap, leaving the actual packages as they are.

TIMETABLES AND EXTENSIONS

Some drug manufacturers were very proactive and started working on incorporating the new format as soon as FDA published its final rule on March 17, 1999. Others have put it off until the last minute and are scrambling to comply by the deadline.

"I have a pretty good feeling that everything that will be due by the early effective date will be ready to go by that time," Bradley says. "Also, quite a few products that don't have to comply by the early effective date will be ready."

Freeze says he has noticed that many of the simpler projects were completed early while the more complicated ones are still being worked on. "If a company has a large amount that can be done with no major changes, those have tended to be done rapidly, while there is a tendency to put off the smaller packages that need to be redesigned until the actual implementation."

Naidrich found that FDA's decision in June 2000 to extend the implementation date on all products for one year also affected the timeliness of projects. "Initially, people were looking to be proactive and wanted to get new graphics down prior to having orders placed," he says. "Then we got the extension and things cooled off, and this was often put to the bottom of the priority list. Now it's back." Thau notes that "[timeliness of projects] has to do with budgets and where [companies] are in the product life cycle."

A few products, mostly ones in smaller packages that have to undergo extensive packaging changes, have applied for an exemption or extension. FDA reports that as of mid-December 2001, there were 39 exemption requests, 26 of which have been addressed.

The agency would not say whether it has granted any exemptions, but Bradley says that "all the requests for outright exemptions that I have heard about have been denied."

"FDA has been pretty firm in want-ing every package to meet the requirements, sooner or later," he says. "We don't think the exemption process is a real exemption process. The only thing FDA seems to be considering is an extension of time when that is necessary to get changes made."

Copyright ©2002 Pharmaceutical & Medical Packaging News