Packaging Can Help Authenticate Your Products

FDA warnings that illegal Web sites could be selling counterfeit drugs may make consumers wary of any drug they cannot authenticate themselves.

In response to recent anthrax attacks, Bayer Corp. and the federal government have worked together to ensure a steady stream of the antibiotic Cipro. They are also working together to counter another threat—potentially illegal sales of Cipro over the Internet. Their cooperation may succeed in halting some of these sales, and it may even help educate consumers about the dangers of buying prescription drugs over the Internet without a prescription. While their efforts should be applauded, not every drug manufacturer will be as lucky to have the government take up its cause so quickly. Drug makers may therefore need to take matters into their own hands.

Within days of the first news of anthrax infection contracted from a letter, several Internet sites began selling Cipro with merely an on-line doctor consultation, if that. One site even sent out an e-mail advertising that it is "now offering Cipro to help build your immune system to fight the anthrax virus! No prior prescription required." Illegal and inaccurate, (anthrax is a bacterium, not a virus), these messages no doubt reached thousands.

FDA quickly responded by issuing warning letters to 11 Internet vendors abroad that were offering ciprofloxacin, the generic name for Cipro. The effect of these letters remains to be seen.

To counter such marketing, FDA is using the Internet to warn consumers. The agency has posted to its site tips and warnings for consumers considering on-line prescription drug purchases, stating that "purchasing a medication from an illegal Web site puts you at risk. You may receive a con-taminated or counterfeit product, the wrong product, an incorrect dose, or no product at all." In addition, says the agency, "there also may be no way for you to tell whether a drug is an ineffective knockoff just by looking at the pills." Such advice may cause Internet shoppers to think twice.

Bayer itself is monitoring the Internet, says Rob Kloppenburg, Bayer's director of communications. "We are cooperating with the government and reporting any suspicious activity. Our recommendation is consistent—people should only get Cipro through a physician by going to a pharmacy."

FDA and Bayer may succeed in stopping all illegal sales of Cipro. But countless other prescription drugs are offered—and sold—over the Internet every day with the click of a mouse and the input of a credit card number. FDA may certainly have issued warning letters to sites selling these drugs without a prescription. Regardless, prescription drugs for serious conditions are still available on-line without a prescription, and if an Internet marketer is selling prescription drugs at incredible bargains without requiring a prescription, there is a good chance these drugs are counterfeit, diverted, or not made according to good manufacturing practices. Patient health and manufacturer liability are at risk.

Manufacturers may therefore be left to themselves to protect their reputations and the health of their consumers. Curtis Hart of Curtis E. Hart Inc., a packaging consultant who has led packaging departments at Abbott, Monsanto, and Searle, advises manufacturers to consider employing several layers of packaging technologies, both covert and overt, to help distinguish an authentic, legally distributed product from that of a counterfeit or diverted one. Manufacturers could then tell consumers through direct-to-consumer marketing what packaging elements to look for in authentic drugs. Just as consumers now ask doctors for prescriptions for specific drugs, they may begin asking for specific brands based on packaging.

For now, however, Bayer isn't changing its packaging of Cipro to counter the possible Internet sale of counterfeit drugs, says Kloppenburg. He says the company is instead relying on the government "to look into such sites." Its priority rather is producing Cipro to meet increased demand. "We are running 24 hours a day, 7 days a week," he explains.

But not every drug manufacturer can leave it up to FDA to police its drug's sales with the same fervor. Manufacturers should therefore look to packaging solutions to authenticate their products. If consumers do heed FDA's warning about prescription drug sales, consumers may just come to expect—and ask for—some sort of visual cue of product authenticity.

Daphne Allen, Editor

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