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Packaging and labeling as crucial as any other manufacturing aspect

Packaging professionals are often misunderstood.

Packaging professionals are often misunderstood.

For example, when environmental concerns are discussed, packaging gets a bad rap as mere waste, as legislators and environmentalists overlook packaging’s contributions to safety, marketing, convenience, and efficiency. And as a cost item, packaging users don’t always appreciate the necessary sophistication of package materials and designs.

Also, the vaguely insulting phrases “It’s only packaging” or “It’s only labeling” are too often used to convey a second-class status for the words and graphics on packaging. The active ingredients, fancy validated processes, and complex control software—those are what really matter, say those without sufficient regard for packaging.

So packagers lament, We need more respect and attention!

On the other hand, take the recent news out of Pfizer, for example: With packaging-related headlines like these, who needs publicity? Yes, it sometimes seems like the only news about packaging is bad news.

Pfizer’s blister-packed birth-control pills were found in a small number of cases to have been packed with pills out of order, or with incorrect amounts of active-ingredient or inert tablets. A Food and Drug Administration press release said “The cause was identified and corrected immediately.” (Wouldn’t it be interesting to know what it was?)

This might best be seen as adverse publicity for the company and product, but also as a good reminder of the value of packaging. Too often considered a secondary afterthought, packaging and labeling should instead be properly viewed as integral to assuring drug product safety and effectiveness. They are, after all, built into the FDA’s Good Manufacturing Practices requirements along with controls for all other steps.

This is often a useful message about labeling specifically, because what you say about a product on its label is at least as important as what it is made from, for purposes of judging whether the product is safe and effective, the two key inquiries about drugs.

Even more evidence of the crucial role of labeling is that one sub-part of the legal definition of a “drug” focuses on the product’s intended use, usually revealed by looking at its labeling, not on its chemistry or formulation (though products that contain known drug chemicals are likely to be considered as intended for drug uses).

It’s an often surprising and somewhat elegant definition that depends on what the packager wants consumers to think the product will do for them. Put a label on a can of Coke saying it will cure cancer, move it in commerce, and poof! that Coke is a drug, and an unapproved, adulterated, and misbranded drug, to boot. And many is the dietary supplement product that FDA declares to be not a dietary supplement at all but actually a drug merely because of the drug-only label claims the packager puts in the product’s labeling and advertising.

Thus, the phrase “It’s just a labeling issue” really is inapt just about always. Maybe you could toss around the phrase in situations where minor label defects have no reasonable effect on the safety of your product, or when you’re trying to persuade an FDA official to agree to let a company use up stock of erroneous labels before making a change. But mostly, the phrase reflects a misunderstanding of the legal framework.

A product could be unlawful because its labeling touts an indication for which the product is not legally cleared—again, it’s made correctly, but claims to be useful for a disease or health-related condition FDA didn’t OK and only for that reason is considered misbranded or adulterated or an unapproved new drug.

It’s not just in FDA’s regulatory realm where labeling and packaging are top-tier considerations. Civil suits over drugs show a similar pattern: It’s what’s said about them, not what’s in them, that increasingly forms the basis of legal claims by injured plaintiffs.

DRI, formerly the Defense Research Institute, is the leading organization of defense attorneys and in-house counsel, and confirms as much. Attorney Gretchen N. Miller, a member of Steering Committee for DRI’s Product Liability Committee and Vice Chair of the Manufacturer’s Risk Prevention Specialty Litigation Group says, “From a liability standpoint, a manufacturer’s statements about its products through labeling and advertising can be just as important as the safety of the product itself. We are seeing an increased focus in product-related lawsuits based solely on what a manufacturer has said or failed to say about its products, not only in traditional product liability lawsuits, but in class action lawsuits as well.”

It would not be an exaggeration to note that every aspect of packaging is crucial—the choice of safe and suitable materials to assure the product is properly protected from air, light, moisture, or contamination, for example; the proper handling of the packaging materials; proper filling; proper development of labeling content and proper application of labeling information; and more—in the sense that getting them wrong has potential consequences to safety, effectiveness, and brand value that are as serious as any other hazard.

You need only think of the birth-control pill packaging problem to appreciate the hazards of packaging errors.

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