Counterfeit drug war continues, threatens supply chain

Key Points

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.

Gren spoke in October in Washington, D.C., at Interchange 2010, a conference sponsored by the Partnership for Safe Medicines, a coalition of individuals and groups working to protect consumers from counterfeit or contraband medications.

Along with counterfeit medications, substandard medications are also always on the rise. These are defined as products made primarily by manufacturers who do not comply with regulatory standards or U.S. Pharmacopeia requirements.

Although the counterfeit drug issue has received more government funding and attention in recent years, it has not received nearly enough, Gren told the meeting, which included the group's members, pharmaceutical professionals, government officials, and others.

Foreign drugs

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.

Diplomatic efforts to address the issue include dialogues with countries such as China, India, and Brazil, and include Department of Commerce initiatives originated by the U.S.-China Joint Commission on Commerce and Trade. Also, a series of seminars and other projects continues under the aegis of Asia-Pacific Economic Cooperation, a forum for the Pacific Rim nations, Gren said.

A growing problem

Another speaker at the Interchange meeting, 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.

A question of resources

Asked at the meeting about resources allocated to the counterfeit drug problem, 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.

Currently, she added, counterfeit drugs are more likely either to cause injuries or to cause patients to receive inappropriate doses of prescribed drugs without their realizing it.

Targeted enforcement

In another session at the partnership's forum, FDA Commissioner Margaret Hamburg said that her agency has now ranked more than 1,000 active pharmaceutical ingredients according to their vulnerability to economically motivated adulteration, so that enforcement can be better targeted.

To jump-start efforts to deal with supply-chain threats that include counterfeiting, economically motivated adulteration, diversion, and cargo thefts, Hamburg said, the agency is creating a new Drug Integrity and Security Program within the Office of Compliance of the FDA's Center for Drug Evaluation and Research.

Hamburg also said that 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 agency will help in efforts to recall these drugs.

However, asked when the requirement that drugs carry a pedigree will be enforced, as mandated by the 1987 Prescription Drug Marketing Act, Hamburg said she could not give a specific answer. That requirement, calling for wholesale distributors (or others not defined as "authorized distributors") to provide a statement of each prior sale, trade, or purchase of a prescription drug, has been held up by regulatory and legal wrangling for 2 decades.