The high cost of prescription drugs in the United States is fueling the search for lower-cost alternatives. But along with the generic formulations of older medicines and purchases from other countries with cost controls comes a dangerous and illegal alternative, counterfeit drugs. It is a problem that law enforcement and health officials all over the world face everyday, with few solutions at hand. But there's a new law in the southern U.S. state of Florida that cracks down on this growing criminal enterprise. On July 21 officials in the state indicted 19 people on charges of stealing and mislabeling prescription drugs. The average American who needs a prescription filled may not think about where or how the medicine was produced. But it's an issue pharmaceutical companies and law enforcement are growing keenly aware of. A tide of counterfeit and unapproved drugs is flooding the United States and much of it is flowing through Miami, Florida, a major commercial center. Investigators recently learned that each year, the Miami international mail facility receives as many as seven million packages containing some form of medicine, which provides a great opportunity for smugglers. Federal authorities are planning a major operation this summer to stem the tide of counterfeit and unapproved drugs entering the United States. According to Greg Jones, with the Florida Department of Health, counterfeiting of prescription drugs is a relatively new problem.
"We only had about five cases in the state of Florida between 1985 and 2000," he said. "But since 2001, between 2001 and 2002, we've actually seen an increase, an actual proliferation, of counterfeit drugs and 10 different counterfeit drugs have moved through our Florida drug wholesalers in the past two years."
Not surprisingly, the most commonly copied drugs are profitable, high-tech medicines. "Most of the drugs we've seen counterfeited have been very expensive biotech injectable products that sell anywhere between $100 up to $400 per vial," he said. "These are drugs used to treat cancer patients and AIDS patients."
Mr. Jones says patients who buy these phony drugs could be getting anything from a reduced dosage of the real medicine, to a contaminated or mislabeled product, or even plain tap water.
"[In] one of the cases, [what] a very innovative counterfeiter in South Florida, did, was to take the product Epogen, a drug used to increase red blood cells, bought a large supply of 2000 units of Epogen, and then actually relabeled the vials, which are the same color as a 40,000, the strongest strength, relabeled these vials to indicate they were 40,000 unit Epogen, which of course they were not," he said. "They had the actual product in them, but at 20 times less strength than the label indicated."
The pharmaceutical industry is a big business in the United States, generating billions of dollars. Greg Jones explains that there are many middlemen between a drug manufacturer and a local pharmacy.
"With the increase in the number of small, what we refer to as secondary wholesalers, that do not sell their drugs to pharmacies or doctors, but they actually buy from one wholesaler and sell to other wholesalers… treating the drugs more as a commodity," he said.
And that, he adds, is what's allowing counterfeiters to get their fake drugs into the legitimate market. "We have found a tremendous amount of corruption in that market, and these wholesalers are the ones that accept drugs illegally, and are the illegal entry point for our mainstream drug supply," he said.
Florida officials hope to address the problem with a new law that took effect July 1, following a statewide investigation into prescription drug theft and counterfeiting. Durell Peden is both a physician and a State Senator who co-authored the legislation.
"This bill established a chain of evidence from the manufacturer to the patient through the wholesale system," he said. "It strengthened the control over the wholesale system in Florida, made them not only have to have an application, [but] to have a criminal background check and have fingerprints and things like that. Before this, there were a thousand or so wholesalers in Florida. There was basically no background check. There was room for a lot of errors, as well as a lot of abuse in the pharmaceutical system."
In addition, Senator Peden says that phony drugs entering Florida were being shipped to other states by some wholesalers. He's confident the new Prescription Drug Protection Act will help keep counterfeit drugs and the criminals who make them out of the nation's medicine cabinets.
"It's a very abusive system and I hope that we can strengthen it even more," he said. "I hope that we have good compliance; I know that we will. I hope that it will save a lot of people's lives."
In addition to monitoring the progress of prescription medicines from the drug-maker to the patient, the Florida Department of Health has begun conducting inspections of manufacturers and wholesalers to ensure the state's drug supply remains pure.