Dr. Margaret Hamburg, commissioner of the US Food and Drug Administration, spoke about the growing problem of counterfeit drugs at last Friday’s Counterfeit Drug Interchange Conference in Washington, DC, hosted by the Partnership for Safe Medicines (PSM), a collection of more than 60 non-profit organizations focused on the safety of prescription drugs. Hamburg discussed the severity of the threat to public health and explained ways that FDA is addressing the issue.

“It is sad to realize that we live in a world in which some criminals are willing to maximize profits by placing poisons in products like infant formula, toothpaste and medically necessary drugs. But it is a reality we must face. And, more importantly, it is a reality that we must become more proactive in dealing with,” Hamburg said.

Hamburg gave several examples of high-profile cases of the harm that fake and adulterated drugs can cause, including the deaths of children in Haiti, Panama, and Nigeria, due to cough syrup and teething medication poisoned with diethylene glycol; the injury and deaths caused by adulterated heparin in 2008; and adverse reports of ineffective insulin, which is believed to have lost its potency after it had been stolen months before and most likely had not been handled properly.

FDA used lessons learned from the heparin crisis to develop a risk-based approach for identifying drugs and active pharmaceutical ingredients that could be targeted for adulteration. Hamburg explained:

“To date, the FDA has systematically ranked more than 1000 active pharmaceutical ingredients in order of their respective risk of economically-motivated adulteration, based on a multifactorial risk-based model that we developed. A subset of these high-risk ingredients is targeted for additional sampling and testing at the border. In addition, FDA is working to reduce the risk that counterfeit or adulterated drug products reach consumers in the US market by developing standards for track-and-trace systems that enable the identification of these products and facilitate efforts to recall them.”

Hamburg said that in addition to new anticounterfeiting technologies such as track-and-trace and authentication systems, more regulatory authority is needed by the agency to help keep counterfeit drugs out of the supply chain. “It is clear that FDA needs new regulatory tools that provide the authority we need to meet the challenges we face in today’s increasing globalized marketplace,” she said. “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.”

More than a hundred governmental and industry stakeholders attended PSM’s inaugural event to discuss solutions to fight counterfeit and adulterated medicines. The Generic Pharmaceutical Association recently became a member of PSM, joining organizations such as the Biotechnology Industry Organization, European Federation of Pharmaceutical Industries and Associations, National Association of Boards of Pharmacy, Pharmaceutical Research and Manufacturers of America, and World Health Organization in the global effort to eradicate unsafe drugs.

Hamburg’s remarks can be viewed on C-SPAN’s video library.

For further reading, see PharmTech’s recent special report on anticounterfeiting technology, “Authentication and Pharmaceutical Protection: An Industry Roundtable.”