Kathryn Foxhall writes an outstanding article in Drug Topics on new efforts by federal authorities to attack the growing issue of counterfeit medications.
The article includes industry insight and relevant statistics. Highlights of Ms. Foxhall’s Drug Topics article include:
• To jump-start efforts to deal with supply-chain threats that include counterfeiting, economically motivated adulteration, diversion, and cargo thefts, FDA is creating a new Drug Integrity and Security Program within the Office of Compliance of the FDA's Center for Drug Evaluation and Research.
• FDA is developing standards for track-and-trace and authentication systems that would enable the identification of substandard prescription drugs as they move along the supply chain.
• The counterfeiters are winning the global counterfeit drug war, with counterfeit medications more abundant than ever before, according to Jeffrey Gren, director of the Office of Health and Consumer Goods in the U.S. Department of Commerce.
• According to FDA, Gren said, 80% of active pharmaceutical ingredients (API) in drugs consumed in the United States come from other countries, mostly from nations that don't have sophisticated regulatory regimes. An API, he said, "may come from China, it may be packaged in the Middle East, it may be sent through Brazil; ultimately it makes it to the United States or other parts of the world," making the problem difficult to solve.
• Nancy Kennedy, senior operations manager of drug investigations in FDA's Office of Criminal Investigations, said that some years ago imported, unapproved, and counterfeit drugs came into the United States addressed to individuals or packaged in small quantities. Then quantities increased, and counterfeits started going to drop-shippers and distributors working from online pharmacy operations. "Now we see quantities of these drugs coming in and going directly to doctors, clinics, brick-and-mortar-pharmacies— and these are for use and distribution directly to patients," Kennedy said.
• Kennedy said that for some time Congress and others have been saying, "Show us the bodies." But there may not be many bodies at one time, she said, unless an event occurs such as the mass poisonings that have happened in other countries.
With the pharmaceutical supply chain threatened by dangerous fakes from all over the globe, it is vital for the supply chain to take proactive steps to protect itself and not wait for regulatory mandates or law enforcement action.
The article includes industry insight and relevant statistics. Highlights of Ms. Foxhall’s Drug Topics article include:
• To jump-start efforts to deal with supply-chain threats that include counterfeiting, economically motivated adulteration, diversion, and cargo thefts, FDA is creating a new Drug Integrity and Security Program within the Office of Compliance of the FDA's Center for Drug Evaluation and Research.
• FDA is developing standards for track-and-trace and authentication systems that would enable the identification of substandard prescription drugs as they move along the supply chain.
• The counterfeiters are winning the global counterfeit drug war, with counterfeit medications more abundant than ever before, according to Jeffrey Gren, director of the Office of Health and Consumer Goods in the U.S. Department of Commerce.
• According to FDA, Gren said, 80% of active pharmaceutical ingredients (API) in drugs consumed in the United States come from other countries, mostly from nations that don't have sophisticated regulatory regimes. An API, he said, "may come from China, it may be packaged in the Middle East, it may be sent through Brazil; ultimately it makes it to the United States or other parts of the world," making the problem difficult to solve.
• Nancy Kennedy, senior operations manager of drug investigations in FDA's Office of Criminal Investigations, said that some years ago imported, unapproved, and counterfeit drugs came into the United States addressed to individuals or packaged in small quantities. Then quantities increased, and counterfeits started going to drop-shippers and distributors working from online pharmacy operations. "Now we see quantities of these drugs coming in and going directly to doctors, clinics, brick-and-mortar-pharmacies— and these are for use and distribution directly to patients," Kennedy said.
• Kennedy said that for some time Congress and others have been saying, "Show us the bodies." But there may not be many bodies at one time, she said, unless an event occurs such as the mass poisonings that have happened in other countries.
With the pharmaceutical supply chain threatened by dangerous fakes from all over the globe, it is vital for the supply chain to take proactive steps to protect itself and not wait for regulatory mandates or law enforcement action.
Deploying technologies, solutions and best practices protect both the supply channel and the consumer.
Businesses that take these proactive steps will be able to differentiate themselves and will be in a prepared protected position when there is a large counterfeit drug incident within the supply chain.
To read the entire Drug Topics article, visit: http://drugtopics.modernmedicine.com/drugtopics/Modern+Medicine+Now/Counterfeit-drug-war-continues-threatens-supply-ch/ArticleStandard/Article/detail/699610?contextCategoryId=40159
To learn about pharmaceutical supply chain solutions, visit: http://www.xstreamsystems.net/
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