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FDA is grappling with a controversy, and packaging is at the center of it.

The agency has postponed its decision whether to approve Plan B (levonorgestrel) tablets, 0.75 mg, for both over-the-counter and prescription sales, in the same package. (Women under a certain age would only be allowed access to the product through a prescription.) Instead of approving or declining Barr Labs' application, FDA is asking for your opinion on of some of the regulatory issues raised by the application, including some packaging issues.

The agency has issued an Advanced Notice of Proposed Rulemaking (ANPR), titled "Which an Active Ingredient May Be Simultaneously Marketed in Both a Prescription Drug Product and an Over-The-Counter Drug Product." The comment period ends November 1, 2005.

"The issues that we were asked to resolve, and the proposal that was put forward by Barr Labs, presented us with many difficult and novel policy and regulatory issues," writes FDA Commissioner Lester M. Crawford. "These are profound regulatory decisions that cut to the heart of our work. The answers to [the questions raised by the application] can establish very broad and far-reaching policies that could have a significant effect on the way FDA regulates many different drugs."

FDA, therefore, needs your input. "Rather than answering these questions in the context of a decision on a single drug, we need to have an open process to solicit public comment." Further, "These regulatory and policy questions are too profound and cut across too many different products to be made behind closed doors."

As it should, FDA is focusing on the broader regulatory questions raised by this application, rather than on just the product itself. The agency calls these questions "unprecedented." For instance, "We have never been confronted with whether the Rx and OTC versions of the same active ingredient may be marketed in a single package," Crawford wrote in a letter to Joseph Carrado, senior director, regulatory affairs for Duramed Research Inc., a subsidiary of Barr Pharmaceuticals Inc.

FDA is therefore posing the question, "Can the prescription and over-the-counter version of the same drug be marketed in a single package?"

The answer, of course, depends upon the package. When shopping for OTC drugs, patients often rely on the package's labeling for product information and usage directions, not a doctor or a pharmacist. Labeling may refer patients to these professionals, but patients don't always seek their advice. Packaging therefore plays a big role in diagnosis and treatment. With such responsibility, packaging must convey uses and warnings clearly and quickly.

It is a tall order for the package, even for routinely used OTC products. Throw in the challenge of meeting rules for both OTC and prescription drugs, and you’ve got quite a chore. But I am sure it can be done. Consider all the tools at your disposal - wallet-style blister cards, expanded-content labeling such as booklet labels and resealable wraparound bottle labels, and other elements that offer a vehicle for conveying product information.

Barr's packaging is certainly designed with the special needs of the patients it serves. But can it serve the needs of both OTC drug purchasers as well as prescription drug patients? FDA’s determination, as well as your answers to the agency’s broader inquiry, will have significant regulatory implications.

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