Counterfeit Medications Gaining Attention

Although the accurate number and dollar value of counterfeit drugs are difficult to quantify, the issue has received attention recently in the United States because pharmaceutical companies are becoming more internationally based and because more people are searching the Internet for medications. In late September, Pfizer Inc and the National Association of Boards of Pharmacy (NABP) announced a partnership warning consumers of counterfeit prescription medicines, which they estimated as a $75-billion market in 2010. The organizations noted that the US Department of Homeland Security Customs and Border Protection seized $5.6 million in illegal pharmaceutical products in 2010, a 170% increase compared with a year earlier. In addition, the NABP found that 96% of the >8000 Web sites selling prescription medicines were in conflict with pharmacy laws and practices. Meanwhile, in a posting on its Web site, the US Food and Drug Administration (FDA) said “the extent of the problem of counterfeit drugs is unknown,” although the World Health Organization estimated the incidence of counterfeits is <1% of medications in developed countries but higher in developing countries. The FDA defines counterfeit medicines as those sold under a product name without proper authorization. They may be contaminated, contain the wrong active ingredients, contain no active ingredients, have the wrong amount of ingredients, or be packaged incorrectly. The FDA warns that the counterfeits could have dangerous side effects and not treat the correct condition. Common types of fraud involve medicines for cancer, HIV/AIDs, arthritis, dietary supplements, and diabetes. Among its initiatives, Pfizer and the NABP created a Web site (www.awarerx.com) and a YouTube channel (www.youtube.com/spotfakemeds) that educate people on counterfeit medicines. The NABP, an independent organization founded in 1904, has created a Verified Internet Pharmacy Practice Sites seal for licensed pharmacies that sell FDA-approved medicines online. The NABP estimates that 1 in 6 people in the United States purchased medications on the Internet in 2010. To deal with the problem, the FDA has established the Counterfeit Alert Network, a coalition of health groups. When a counterfeit drug incident is discovered, the FDA sends a message to network members, hoping to disseminate the information quickly and minimize any issues. Network members are the American Academy of Family Physicians, American Academy of Nurse Practitioners, American Academy of Physician Assistants, American College of Clinical Pharmacy, American College of Physicians, Academy of Managed Care Pharmacy, American Medical Association, American Pharmacists Association, American Society for Aesthetic Plastic Surgery, American Society for Health-System Pharmacists, Healthcare Distribution Management Association, National Association of Chain Drug Stores, National Association of Pediatric Nurse Practitioners, National Community Pharmacists Association, National Consumer League, Partnership for Safe Medicines, and Physicians Coalition for Injectable Safety. FDA Commissioner Margaret A. Hamburg, MD, discussed counterfeit medications in October 2010 at the Partnership for Safe Medicines Interchange in Washington, DC. According to prepared remarks posted on the FDA’s Web site, Dr. Hamburg said that with companies moving their manufacturing operations outside of the United States in recent years, there has been an increase in the volume, variety, and complexity of imported products. Thus, the supply chain is becoming larger and more difficult to track, leading to a proliferation of counterfeit drugs. She said that “it’s hard to really know the full extent of the problem,” but she added that “what we do know is that it is growing every day.” “When our agency approves drugs based on scientific evidence and federal legal standards, the American people have every right to expect that the medicine they rely on for treatment is exactly what the package and label says it is—a medicine that has been carefully evaluated by the FDA in terms of safety, efficacy, quality, and purity,” Dr. Hamburg said, according to the transcript. “Drug counterfeiting involves larceny and fraud on several levels. Certainly, it involves theft against the drug manufacturer, but perhaps even more importantly, it robs the American people of the faith and confidence they deserve to have in drug products they believe are FDA approved. Passing off a fake medical product or stealing it for redistribution on a gray market is a direct and indirect threat to public health.” Dr. Hamburg addressed a few noteworthy incidents. In 2006, children in Haiti, Panama, and Nigeria died from tainted cough syrup and teething medication poisoned with diethylene glycol. Also, patients throughout the world died from adulterated heparin in 2008. In 2010, according to Dr. Hamburg, patients who received counterfeit over-the-counter diet pills and suffered from cardiac problems were at great risk. Since the heparin contamination occurred, Dr. Hamburg said the FDA has done a more thorough job inspecting manufacturing and testing facilities and instituted a requirement that tests whether the contaminant in heparin (oversulfated chondroitin sulfate) is present. She added that the FDA has applied the same strategy to examine other drugs and mentioned the FDA uses a multifactorial risk-based model to identify pharmaceutical ingredients that may be at risk for adulteration. During the speech, Dr. Hamburg announced the creation of the Drug Integrity and Security program in the FDA’s Center for Drug Evaluation and Research. She said the program would “specifically focus on issues such as counterfeiting, economically motivated adulteration, diversion, cargo theft, and other supply chain threats.” She added that the FDA has an internal group that works on counterfeit medications across the agency’s departments. “It is also clear that the agency needs new regulatory tools that provide the authority we need to meet the challenges we face in today’s increasing globalized marketplace,” Dr. Hamburg said, according to the transcript. “And we look forward to working with Congress on legislation that will give FDA the ability to protect Americans from harmful drugs and medical products—and fulfill our fundamental public health mission.”