MIT Anti-Counterfeit Drug Pioneer Joins SupplyScape

02/16/2005

SupplyScape Corporation, a leading provider of pharmaceutical supply chain technology, today announced MIT Auto-ID Labs expert Robin Koh has joined the company as chief strategy officer. While at MIT, Koh led the university's groundbreaking work with the Food and Drug Administration (FDA), developing methods for fighting counterfeit drugs with technology. In addition, Koh spearheaded MIT's collaboration with the pharmaceutical industry to turn the FDA vision into solutions that will work in today's intricate supply chain.

"Thousands of Americans are at risk each year from ingesting counterfeit and substandard drugs, yet technology is ready today to help make the drug supply safer," said Koh. "I'm now moving from working with governments and industry to plan for a safer supply chain, to helping companies deploy technology in the field that will have an immediate impact on patient safety."

Millions of counterfeit prescriptions are dispensed each year. According to a November 2003 fact sheet issued by the World Health Organization (WHO), until April 1999, of the 771 cases of counterfeit drugs reported to WHO, only 7% contained the correct amount of active ingredients. Unfortunately, a large portion of the phony drugs are medications essential for the severely and chronically ill to stay alive. Since 2000, FDA criminal investigations of drug counterfeiting have increased tenfold.

Counterfeit Drugs: What's in Your Medicine Cabinet?

Since 1987, the FDA has urged the pharmaceutical industry to increase patient safety by tightening its supply chain's vulnerability to counterfeits. The FDA recommends, and several states now mandate, a drug pedigree, a certificate of authenticity detailing a drug's movement through the supply chain. Without the pedigree, it is difficult to determine where a drug has been and if it is safe.

"Robin has been an invaluable resource for the FDA in the development and implementation of the policy related to RFID technology and the electronic pedigree. His unique understanding of the pharmaceutical supply chain and RFID itself has enabled him to develop a vision for how the U.S. drug supply can be kept safe and secure while also promoting efficiency," said Paul Rudolf, medical officer, the Health Strategies Consultancy, and former FDA lead on RFID and counterfeit drug policy development. "Robin will help the industry clearly understand how electronic pedigree systems can be deployed immediately, thereby making the U.S. drug supply safer and improving the public health."

With the U.S. pharmaceutical market reaching annual sales of $200 billion, drug counterfeiters are becoming highly sophisticated. Counterfeiters infiltrate the drug supply with knock offs that look identical to legitimate drugs. The fakes are often missing active ingredients, are diluted, or have been otherwise contaminated. Others are intentionally mislabeled to misrepresent the product's potency or extend the expiration date. A large portion of these counterfeits are reaching pharmacies and unsuspecting patients.

For three years, Koh worked with the FDA to identify vulnerabilities in the drug supply system, and create a strategy to make the system safer, primarily through the use of pedigrees. In fact, as director of applications research at the MIT Auto-ID Lab through 2004, Koh was one of the first in the world to identify the ability of technology to bolster the safety and security of the pharmaceutical supply chain. In addition, Koh brings 17-years experience increasing profits by improving complex, multinational supply chains for such companies as Pepsi-Cola, Arrow Electronics, General Motors and Hewlett-Packard.

The problem of counterfeits does not stop with patient safety. Counterfeiting costs the industry millions of dollars each year due to sales lost to phony drugs and costly recalls.

According to Koh, solutions are ready today from several companies that can help mitigate the public's risk to counterfeit drugs. "For the first time, the industry is in a perfect position to comply with pedigree laws in a cost-effective and non-disruptive manner," said Koh. "There is no need to wait; the time to deploy is now."

In November 2004, the company launched SupplyScape E-Pedigree software. In addition to providing full compliance with federal and state pedigree laws including Florida, California, Colorado, and Nevada as well as the recommendations of the FDA and the National Association of Boards of Pharmacy (NABP), the system streamlines business operations and enables companies to safeguard prescription drugs, improve the speed and quality of shipping and receiving, expedite returns processing and improve recall precision.

"Bringing Robin's knowledge and experience to bear on the growing problem of counterfeit drugs is a great leap forward to securing patient safety," said SupplyScape President Shabbir Dahod. "Working directly with pharmaceutical suppliers and wholesalers, Robin will accelerate the deployment of technology which will help to realize the FDA's long-time vision of a safe and secure supply chain."