ANNAPOLIS – As counterfeit drug traffic continues to rise in Maryland, pharmaceutical industry leaders are urging lawmakers to crack down on distributors who may be tampering with drugs.
Every year, an estimated 800,000 prescriptions are filled with counterfeit drugs in Maryland, according to the Food and Drug Administration. This puts consumers at risk from taking drugs that are too weak, too strong or that contain no medicine at all. While industry leaders insist the United States has the safest drug distribution system in the world, the rising number of fake and adulterated drugs moving around the country has caused concern.
“Counterfeiting drugs is pure fraud,” said Mark Levi, a member of the Maryland Board of Pharmacy. “And it’s growing fast.”
In 2004, the FDA investigated 58 counterfeit drug cases nationally, up from 6 in 1997. The World Health Organization estimates that worldwide sales of counterfeit drugs have reached $32 billion annually. Some countries, including Mexico and Argentina, have counterfeit drug rates as high as 40 percent.
Lifestyle drugs, like Viagra, are the most common drugs to be counterfeited, but now more expensive drugs, like medication used to treat cancer and HIV/AIDS, are being tampered with more frequently. In 2003, Pfizer recalled 1.8 million pills – some of which had been dispensed to patients in Maryland – of it’s popular cholesterol-lowering drug Lipitor.
Although counterfeit drug traffic is not as high in Maryland as it is in other states, pharmaceutical leaders warn that it could become a severe problem overnight. Two of the nation’s largest prescription drug wholesalers – Cardinal Health Inc. and McKesson Corp. – have major distribution centers in Maryland.
But nationwide, more than 6,000 smaller secondary distributors buy and sell drugs that don’t come directly from the manufacturer, which increases entry-points for counterfeit drugs, said Bill Pitcher, a lobbyist for PhRMA, a leading pharmaceutical manufacturer.
The rising tide of counterfeit drugs, stems from lax regulations of drug wholesalers and more sophisticated technology that allows criminals to produce pills and packaging that are identical to the authentic product, said Francis B. Palumbo, executive director of the University of Maryland School of Pharmacy Center on Drugs and Public Policy.
More rigorous licensing requirements and stricter documentation showing the origin of the drugs could help eliminate distributors that sell medicine from illegitimate manufacturers, he said.
Currently, a distributor can obtain a license to operate in Maryland by paying a $300 fee and passing a single inspection. There are about 600 wholesalers licensed in Maryland.
“There’s no background check, no follow-up inspection,” Levi said. “At that point, these distributors can do whatever they want and we’d never know.”
Yesterday, the board appointed a task force to look at current regulations and suggest solutions for new legislation.
In 1987, a federal law passed that requires prescription drug distributors to receive a license in the state where their facilities are located. Since then, many pharmaceutical companies have merged and the number of prescriptions dispensed has doubled, making it more difficult to regulate distributors who operate across the country. The FDA is urging states to adopt an electronic tracking system to monitor the journey of drugs from the manufacturer to the patient. But that technology is not expected to be ready until after 2007.
Stronger national guidelines would make it easier to regulate distributors who operate in all 50 states, “but it’s such a significant problem that something has to be done while we wait for the feds to act,” said Daniel Bellingham of the Healthcare Distribution Management Association, which represents 46 wholesale companies across the country.
Last year, 11 states adopted bills that require a “drug pedigree” system, a record that shows every step a drug takes before reaching a patient. The laws also required more scrutiny of companies before they are eligible for a license.
A bill with similar objectives failed during Maryland’s last legislative session, but is now receiving more interest from delegates serving on the House’s pharmaceutical subcommittee. The proposed law will require distributors to put up a $100,000 bond, as well as periodic inspections after the license is issued.
“As more states pass legislation, those states that do nothing are more at risk of the fly-by-night distributors moving in,” said Delegate Joan F. Stern, D-Montgomery, who sponsored last year’s bill and plans to introduce a similar one in January.
While regulating wholesalers won’t help curb the number of counterfeit drugs entering the country by Internet sales or mail-order sales from Canada, “it will help us close in a little more on the problem,” Palumbo said.” “We believe there are billions of dollars worth of counterfeit drugs coming into our country, we just don’t know where they’re going,” Stern said. “We want to make sure that if distributors are coming in, they’re not being sold in Maryland.”