Catching Up with the FDA’s Counterfeit Drug Task Force

By Eric Van Osten

In July of 2003, the Food and Drug Administration’s (FDA) Counterfeit Drug Task Force was created to identify steps that the FDA, other government agencies, and the private sector could take to decrease the risks posed by counterfeit drug distribution in the U.S. By October of 2003, the Task Force had generated an interim report, and in February of 2004, it issued an updated report (www.fda.gov/oc/initiatives/counterfeit/report02_04.html). In it, the FDA called for widespread adoption of electronic track-and-trace technology to create an e-pedigree by 2007 to combat the growing health problem of counterfeit prescription drugs. It recommended RFID technology, saying it was one of the most promising technologies that could be used to achieve this goal.

On February 8th and 9th, the FDA Counterfeit Drug Task Force held a public workshop/vendor display in Bethesda, MD, to examine the obstacles that may slow or impede the adoption of electronic track-and-trace technologies. The Task Force is preparing a report based on what it learned at the public meeting and from comments placed in a public docket. The FDA plans to go public with this report in May 2006. The FDA workshop highlighted RFID technology as one of the best methods for upholding electronic pedigree. Four hundred registrants packed the event, and 27 vendors displayed their solutions for countering drug counterfeiting. Also present were representatives of companies who manufacture and distribute pharmaceutical products, as well as EPCglobal.

Randall Lutter, Ph.D., Associate Commissioner for Policy and Planning, Office of the Commissioner, gave a lecture at RFID World, in Dallas, TX, on March 1. He spoke about the promise that electronic track-and-trace technologies like RFID offer in the fight against counterfeit drugs in the U.S. This lecture can be viewed at www.fda.gov/oc/speeches/2006/rfid0301.html.

In his speech, Lutter explained why the Task Force believes electronic track-and-trace technologies like RFID offer substantial advantages to FDA in its effort to ensure the protection of the drug supply and to the pharmaceutical industry. RFID, along with software solutions and hybrid technologies, could create a chain of custody for FDA-approved products that would deter peddlers of diverted or counterfeit drugs, leaving them unable to sell to unsuspecting U.S. parties, including wholesalers, pharmacists, and patients. E-pedigree technologies can enable pharmacists at drug stores and hospitals to be more confident of the safety and efficacy of drugs they possess and distribute. Increased certainty in goods could provide savings to manufacturers, wholesalers, retailers, and patients by knowing the legitimacy of the goods and offering better inventory management.

This public service advertisement can be picked up from the FDA’s Web site for use in print publications, to educate readers about the dangers of counterfeit drugs.

Track-and-Trace and Authenticity

Ilisa B.G. Bernstein, Pharm.D., J.D., Director of Pharmacy Affairs, Office of the Commissioner, U.S. Food and Drug Administration, says that the Task Force’s report offered two major ways technology can help in the fight against this problem. “It can play a role through tracking and tracing, so that you know who has the product at all times, where it has been, and where it is going—to ensure that it’s been in the right hands along the way,” Bernstein says.

Secondly, authentication technology is important to ensure product validity. “Things like holograms, taggants, and security inks are suited for this,” Bernstein continues. “RFID has a role in both ways to secure the product and also as a tracking tool, but RFID alone is not 'the one’ defense against counterfeit drugs. That’s why we think the 'multi-layer approach’ is what is needed in the marketplace in the supply chain.”

With this approach, a company chooses which technology will best secure its product, on top of whatever electronic track-and-trace feature is being utilized, whether it’s RFID technology, barcode technology, or other emerging technologies. Bernstein adds: “Using security inks, holograms, and taggants is something that we believe a manufacturer would take, in regards to risks of their product being counterfeited or diverted, and see what the best cost benefit for that company is for adding the technology. You have to look at the costs, the vulnerability of the product, and what works best.”

There are many benefits in terms of cost management for the product that RFID can provide to supply chain stakeholders besides track-and-trace and authenticity, such as inventory control, theft control, and recall management. “It will really go a long way towards insuring that a patient gets the right product, the genuine product,” stresses Bernstein.

Counterfeit Drugs on the Internet

A major obstacle that the FDA and pharmaceutical companies face is monitoring and combating counterfeit drug distribution over the Internet. It is a problem that is hard to control, according to Bernstein, because as illegitimate Internet pharmacies are discovered and shut down, other new ones constantly appear somewhere else. The FDA does have a very active office of criminal investigation focusing its resources on monitoring and combating counterfeit drugs over the Internet.

The FDA’s biggest effort, though, is trying to educate consumers about how to buy drugs safely. There are some licensed Internet pharmacies that are perfectly legitimate. The goal is to educate consumers on how to identify the good pharmacies versus the bad ones. “We are putting resources into the 'enforcement route,’ but we are also going the 'education route’ as well,” says Bernstein.

The FDA’s Web site possesses a significant amount of information in its “Buying Medicines and Medical Products Online” section: www.fda.gov/buyonline. It makes available educational materials, brochures, and public service announcements for use in newspapers, journals, and magazines, as well as health professional organizations who are trying to educate their patients.

Ilisa B.G. Bernstein, Pharm.D., J.D., Director of Pharmacy Affairs, Office of the Commissioner, U.S. Food and Drug Administration is on the FDA’s Counterfeit Drug Task Force and has been working on this issue since the Task Force was created in 2003. Please visit the FDA online at www.fda.gov. Download PowerPoint presentations from the FDA workshop at www.fda.gov/oc/meetings/rfidagenda.html.