HEALTHLAW -- June 24, 2010 at 1:04 PM ET
Fake Drugs A Global Health Threat
Fake drugs manufactured to resemble dozens of well-known pharmaceutical brands are making their way across international borders and threatening lives, the World Customs Organization said Thursday.
"Countries across the globe, in particular those in Africa, suffer the scourge of being flooded with fake and sub-standard medicine," WCO Secretary General Kunio Mikuriya told the group's 176 member countries.
Malaria tablets, heart treatment medication and H1N1 vaccines are among the drugs being sold in counterfeit form, making up 10 percent of worldwide pharmaceutical sales, according to former French President Jacques Chirac, who spoke to the organization.
"Men, women and children are dying because criminal networks are making money from the trafficking of fake medicines," said Chirac. "No one knowingly buys a product that could threaten his life or that of one of his loved ones."
Chirac noted that in developed countries more and more people are buying medications over the internet and through channels that are difficult, if not impossible, to regulate.
Roger Bate, an economist who writes about the issue at the American Enterprise Institute for Public Policy Research, said in an email that although the scale of the problem is much bigger in the least developed countries, the counterfeit manufacturers are focusing their efforts on wealthier nations because of the value available in those markets.
The U.S. Food and Drug Administration warned last week that fake versions of the flu drug Tamiflu were being sold without prescription through internet pharmacies, and that the drug contained an active ingredient that could be deadly to people allergic to penicillin.
The fake and substandard drugs being sold for profit sometimes contain a little of the genuine active ingredient but often contain a random mix of cheaper pharmaceuticals that could have dangerous effects.
Ilisa Bernstein, deputy director of the office of compliance at the FDA said the agency regularly monitors online pharmacies and will sometimes make purchases and test products. Complaints from pharmaceutical companies or consumers can lead to an investigation.
"It's very challenging, there are a lot of different ways that products that have poor quality, that are not safe, that are not effective, can get to U.S. consumers," said Bernstein, who recommended staying away from internet purchases and any informal sale of drugs.
China and India are major sources of the fake drugs hitting the U.S. market, but they can come from anywhere said Bernstein, and the range of fake drugs is wide, from Viagra to the over-the-counter weight-loss pill Alli.
Vice President Biden announced a plan this week to target intellectual property infringement of all kinds, including fake drugs. The plan proposed creating an interagency committee focused on fake medicines and products, as well as legislation to require companies to alert the FDA when they learn of a counterfeit medication on the market.
WCO is also aiming to crack down on the growing industry. Mikuriya signed the Chirac Foundation's Cotonou Declaration Thursday, as a symbol of the organization's commitment to beef-up border enforcement operations.
Bate applauded the move but said it would likely only have a small impact on the trade, because many active pharmaceutical ingredients are traded over borders, then manufactured into poor quality medications in country.