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Risky Business

As the counterfeit drug trade grows, U.S. manufacturers and the FDA are working to find a solution. Read on to explore the issues behind phony pharmaceuticals, and what’s being done to identify and eliminate them.

For years, counterfeit pharmaceuticals were thought to be a dirty little secret whispered about, but well-contained, in Third World countries. In recent years, however, the very lucrative counterfeit drug trade has rode into the U.S. by way of the information superhighway’s Internet pharmacies and a growing number of unscrupulous secondary distributors.

Food and Drug Administration estimates peg worldwide counterfeit pharmaceuticals as a $3.5 billion industry, but the Center for Medicine in the Public Interest (CMPI), a charity backed by the U.S. pharmaceutical industry, suggests figures may be 10 times higher and growing rapidly with global sales of fake drugs reaching $75 billion by 2010, according to a recent article in The New Scientist.

While phony pharmaceuticals pose a financial blow to the legitimate pharmaceutical industry, the real concern is the danger to consumers. According to CMPI’s web site, experts fear that, globally, the trade in counterfeit pharmaceuticals kills more people and causes more harm than illegal narcotics.

Dangerous Fakes

“U.S. law defines counterfeit drugs as those sold under a product name without proper authorization, where the identity of the source of the drug is knowingly and intentionally mislabeled in a way that suggests that it is the authentic, approved product,” says Randall Lutter, associate commissioner for Policy and Planning with the FDA. “This definition can apply to brand name products, generic products, or the bulk ingredients used to make the drug product.”

(The FDA maintains that no fatalities have been causally linked to specific counterfeit drugs in the last decade.)

Through The Cracks

While the risks associated with phony pharmaceuticals are very real and very frightening, in the grand scheme of things, counterfeits are less prevalent in the U.S. than in other countries.

“Worldwide the problem is quite significant, but in the U.S. the problem is fortunately somewhat under control because we have laws and regulations that go a long way to securing the supply chain,” says Alan Goldhammer, associate vice president of regulatory affairs with the Pharmaceutical Research and Manufacturers of America (PhRMA).

“The government has taken steps over the last several years to weed out some of the wholesalers that cause problems in the supply chain," he said.

The FDA agrees, but its statistics show the trend is growing in the U.S.

“Although our experience tells us that the number of counterfeit drug products entering the U.S. drug supply chain remains low, we have witnessed an increase in counterfeiting activities and a greater capacity to introduce counterfeit drugs into legitimate drug distribution channels,” says Lutter.

Because counterfeiting is difficult to detect, investigate, and quantify, experts say it is hard to know the true extent of the problem here.

“Nearly 4 billion prescriptions were filled last year,” says Lutter. “That means a very large volume of drugs is moving through the supply chain. The sophistication and precision of some counterfeit copies of legitimate drugs make a reliable estimate of the number of counterfeits impossible.”

Outside the U.S., however, drug counterfeiting is widespread and easier to pin down. In Southeast Asia, approximately 10 percent of the drugs on the market are believed to be fakes. In China, authorities believe that for some drugs, the estimated average of counterfeit copies can be as high as 50 percent. It is also reported that in underdeveloped countries such as Argentina, Colombia, and Mexico, up to 40 percent of manufactured pharmaceuticals are believed to be counterfeit.

Silver Bullet?

Because many of the counterfeit drugs are intended to provide treatment for very sick patients, such as those with AIDS and cancer, it is not the lack of legality or loss of profits but the potential loss of life that merits attention – namely in the form of developing anti-counterfeiting technologies – from the industry and government.

The FDA initiated a Counterfeit Drug Task Force in 2003 to develop recommended actions that the FDA, other government agencies, and industry can take to minimize the number of counterfeit prescriptions entering the U.S. drug distribution system.

Some of the most recent recommendations from the task force include the widespread use of electronic track and trace technology.

“This will help secure the integrity of the drug supply chain by providing an accurate drug ‘pedigree,’ which is a record of the chain of custody of the product as it moves through the supply chain from manufacturer to pharmacy,” says Lutter.

The FDA implemented a regulatory requirement for documented records, or pedigrees, for all drugs entering the market by Dec. 1.
“This new paper trail will provide additional protection and certainty to the supply chain,” says Ken Johnson, senior vice president of PhRMA.

RFID tags are highly recommended by the FDA to achieve an electronic pedigree. The agency is pushing for widespread adoption of RFID technology as a form of electronic track and trace by 2007. Other recommendations include overt and covert features, such as color shifting inks and holograms, incorporated into packaging and labeling of a prescription drug.

“While these technologies are helpful in resisting counterfeiting, they are limited and are not a silver bullet,” says PhRMA in a statement. “Counterfeit-resistant technologies do not provide real-time verification of a drug’s authenticity. Visual inspection of drug packaging and labeling is not a viable method for accurately identifying counterfeits.”

According to the Department of Health and Human Services report on importation issued in December 2004, while a number of new anti-counterfeiting technologies show potential for ensuring the safety and authenticity of prescription medicines, they can’t be relied upon to secure the global market until they are universally adopted. The report also states that the associated cost may be prohibitive.

“Widespread adoption of authentication technologies, while theoretically able to secure the U.S. drug supply, is a daunting task that could raise the cost of imported drugs, thereby reducing any expected savings from importation,” states the report.

Perhaps because packaging technologies can be foiled and are costly to implement, pharmaceutical processors are getting more sophisticated in how they formulate drug products.

“They may add inert ingredients of a proprietary nature that can be detected under chemical analysis to distinguish their drug from a fake,” explains Goldhammer. “They can look at the purity profile so they know whether the drug was manufactured by them or is a counterfeit.”

But even this technology is not without its drawbacks.

“If a consumer buys a prescription and is concerned, the only way the drug can be authenticated is to have it sent back to the company,” notes Goldhammer.

“There is no single magic bullet to prevent counterfeit drugs from entering the nation’s pharmaceutical supply chain. But there are many effective tools,” says Johnson. “We will continue to work with the FDA, pharmacists, physicians, and supply chain partners to implement the mechanisms necessary to protect patients. We want to make sure they receive safe and effective FDA-approved medicines.”

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