That drug you're counting on may not be what it appears. As counterfeiters become more sophisticated at copying drugs like Viagra, the industry is scrambling for ways to protect its wares
Counterfeiters have moved beyond bogus currency and fake designer handbags into the lucrative world of prescription drugs, setting off a technology race to foil copycats who profit on phony pharmaceuticals.
In response to a call for ideas from the Food and Drug Administration, scores of companies and researchers have emerged to pitch their innovations. Some are very nearly the stuff of science fiction, like pills that carry aromas and tastes immediately recognizable to a patient but difficult for crooks to duplicate. Counterfeiting countermeasures also include the use of holograms and invisible inks on individual drug packages, tiny transmitters that permit radio tracking of drug shipments, and infrared light beams that can instantly detect fake pills.
Colorcon, a Pennsylvania company that manufacturers coatings for tablets, has developed sophisticated, "pearlescent" surfaces for tablets and has figured out how to print miniature bar codes onto every tablet. The advanced techniques were originally developed for branding purposes and to prevent medical errors, but the company said they work better than packaging changes to ensure authenticity.
"Packaging technologies are not always that difficult to fake," said David Schoneker, director of global regulatory affairs for Colorcon, which also developed the flavors and aromas for pills. "We're trying to think out of the box."
But a number of firms, such as GenuOne Inc. in Boston, are pushing combinations of "trace and track" technology and computer software to help drug manufacturers keep better track of drug shipments. GenuOne puts special inks onto packages that can then be detected by scanners. Traceable packaging changes have the added advantage of helping with sales flows and inventory.
"At the end of the day, it's all about control of your products," said Stephen Polinsky, vice president for business development at GenuOne.
At stake in this technology push is public confidence in a poorly regulated US pharmaceutical supply line that has been hit with a number of high-profile counterfeiting cases in the past several years. The number of investigations into drug counterfeiting by the FDA has jumped from five new cases a year in the late 1990s to more than 20 every year since 2001.
In addition to huge sellers like Pfizer Inc.'s Lipitor, the cholesterol fighter, and Viagra, for male sexual dysfunction, counterfeiters have targeted a variety of expensive biotech drugs for cancer patients, like Amgen's Epogen. Counterfeiters in Florida filled phony vials of Procrit, an anti-anemia drug, with Miami tap water.
The response by the Food and Drug Administration has been to create a high-level task force to develop guidance for industry by the end of this month. None of the technologies are in widespread use in the pharmaceutical industry yet, but they hold promise to make life difficult for counterfeiters, and in turn, safer for consumers.
These technologies come with a price tag: for drug companies, for wholesalers and drugstores, and ultimately for consumers. Consequently the industry is in a holding pattern, studying costs and awaiting signals from the FDA.
Ultimately, the FDA is likely to recommend a multilayered security approach, encompassing both radio frequency track-and-trace systems and authentication features like hard-to-copy colors and chemicals embedded in the pills.
"You need a cascading system of protections here," said William Hubbard, the FDA's associate commissioner for policy and planning. "You need the manufacturers to do some things, wholesalers and retailers to be more vigilant, and you need to tell consumers what to look out for."
Neither the FDA nor the Pharmaceutical Research and Manufacturers of America had estimates on costs of these sweeping initiatives. Radio-frequency identification on individual pill bottles would easily run into the multiple billions, as industry estimates place the added cost for each pill bottle at about 25 cents.
But Lewis Kontnik, a Colorado-based anticounterfeiting consultant, said the potential cost of inaction is much larger than the price of the fix.
"The question is what is the cost if you don't go ahead with it," said Kontnik said. "Could there be litigation, product recalls, damage to share-price value?"
Among 75 companies and individuals who presented information at an October FDA anticounterfeiting forum, the most frequently proposed anticounterfeiting strategies were electronic tracking systems, using radio transmitters and scanners, to allow manufacturers to literally keep tabs on every bottle of pills moving through the pipeline. The advantage of radio frequency systems is the supply can automatically be tracked as it passes through a loading dock or pharmacy shelf, without the need for employees to scan printed bar codes.
"A number of major pharmaceutical companies are getting very interested," said Henri Barthel, general manager of EPC Global Inc. in Brussels, a global nonprofit corporation that is setting international standards for radio frequency ID.
He cited Johnson & Johnson, GlaxoSmithKline, and Bayer as firms that are actively investigating this approach. The move to radio frequency tracking is being accelerated by the Department of Defense and Wal-Mart, which are requiring suppliers to affix transmitters to products.
Still, the new technology is not expected to be widespread in the pharmaceutical industry for several years. The National Association of Boards of Pharmacy is recommending that its members -- state pharmacy regulators -- require electronic tracking technology on all prescription products by 2007.
And Alan Goldhammer, associate vice president for regulatory affairs at PhRMA, the drug makers' trade group, said widespread use in the drug industry is a "long-term" goal. The industry is still studying costs and the complicated logistics of setting up a huge database and computer network, he said, and will produce its own report in April.
"I don't think anybody feels the technology is ready right now," he said.
Strategies like adding "taggant" ingredients to authentic drugs and introducing exotic coatings and tastes will take even longer to introduce to the marketplace, said experts. One hurdle is regulatory. Even benign additives need to be tested for safety and side-effects and approved by the FDA. But advocates of some of these advanced ideas say they ultimately hold more promise than tracking packages.
Researchers at the University of Maryland said they have developed an infrared light, for example, that scans a pill and detects whether compounds are present in the correct amounts. It is sensitive enough to pick up deviations of a half a percent, said James Polli, a professor at the university's School of Pharmacy. He envisions a day when the device is installed in drugstores and pharmaceutical warehouses across the country.
One new company, the result of several merged firms, is Authentix, based in Dallas. It helps drug companies develop chemical "taggants" that are contained in the medicine. It already has performed the job and won FDA approval for some products, but Philip Martin, vice president for business development, would not provide any details or identify the companies or medicines involved.
"That would defeat the purpose," he said.
In the immediate future, two drug companies, Pfizer and Johnson & Johnson, have opted for a virtual lock-down on their supply line. They have warned large wholesalers not to purchase drugs from anyone but the manufacturer or a licensed wholesaler. Pfizer said it is still evaluating the options.
"A technology solution in isolation is not going to do it," said Pfizer spokesman Paul Fitzhenry.
Eric Turkowitz, a New York lawyer representing a 16-year-old liver-transplant patient who survived after being given counterfeit drugs, said that is a better approach than all the whiz-bang technology.
"The counterfeit threat will continue to exist," he said, "as long as you have the major players buying drugs from unknown individuals."
Christopher Rowland can be reached at firstname.lastname@example.org.