Drug Topics: Counterfeit Drug War Continues, Threatens Supply Chain

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.

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/

ASHP: Counterfeit Drugs Pose Growing Health Threat

Counterfeit and substandard medicines constitute a real and growing threat to public health, say federal officials and others who deal with the issue.

Kate Traynor in the American Society of Health-Systems Pharmacists Health Systems News writes an excellent report with some insightful quotes about the October symposium on counterfeit medications that was sponsored by the Partnership for Safe Medicines in Washington D.C.

Included in Ms. Traynor’s story:

• "The problem is getting worse each year. The counterfeiters are winning," said Jeffrey Gren, director of the Office of Health and Consumer Goods at the U.S. Department of Commerce.

• Nancy Kennedy, senior operations manager at FDA's Office of Criminal Investigations, said that counterfeiters previously limited their activities to bringing small amounts of fake medicines into the United States. "Now you see quantities of these drugs coming in and going directly to doctors, clinics, brick-and-mortar pharmacies and...directly to patients," Kennedy said. "I can see international cases' connections growing, and the type and amount of counterfeit drugs and unsafe drugs coming into the country is significantly growing. So I don't like what I see."

• More than 60 nonprofit organizations, including ASHP, are members of PSM, whose stated goal is to raise awareness about the risks of counterfeit medications. The symposium was sponsored by several pharmaceutical companies and other corporate stakeholders.

• FDA Commissioner Margaret Hamburg, the event's keynote speaker, said that in some parts of the world, 30–50% of drugs used to treat serious illnesses are counterfeit products.

• "Still, it's hard to really know the full extent of the problem," she said. "Estimates...vary a lot, and we do need better surveillance and data to truly define the magnitude and scope of the problem."

• FDA announced in the October 13 Federal Register that the agency will commit up to $3.5 million to the World Health Organization for the development of a rapid global surveillance and monitoring system for counterfeits, if the health agencies agree on a cooperative approach to the project.

Industry leadership and consumers in developed countries must be made aware of the danger of counterfeit and substandard medications and that this is no longer just a threat that exists within the third world.


Real solutions and technologies exist today that can eradicate the threat from this dangerous, lethal criminal activity. The global pharmaceutical supply chain must be incentivized to deploy these solutions to protect their brands and the consumer.

To read the entire ASHP article, visit: http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3428

To learn more about anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.