The trade in illegitimate medications is a global public health problem that requires a global solution, according to a nearly 300-page report from the Institute of Medicine.
Commissioned by the U.S. Food and Drug Administration, the report centers on two categories of poor-quality drugs: substandard, or those that don't meet the specifications in an accepted pharmacopeia or manufacturer's standards; and falsified, or those that carry a false representation of identity, or source, or both.
While those kinds of drugs often contain toxic ingredients, the more common problem is that they don't work, the report noted. For example, poor-quality drugs have led to the rise of drug-resistant tuberculosis, and drug-resistant staphylococcus infections are appearing in India, Latin America and sub-Saharan Africa. Citing the Pharmaceutical Security Institute—a network of 25 pharmaceutical companies' security divisions—the report noted that the illegal trade and manufacture of medications affected at least 124 countries in 2011, with developing countries hit hardest.
Consequently, the IOM said the World Health Assembly (the decisionmaking arm of the World Health Organization) should work with the United Nations Office on Drugs and Crime and the World Customs Organization to establish a transparent process for developing a code of practice on falsified and substandard medicines. That code should include guidelines on surveillance, regulation and law enforcement, and it should enable states and the international community to both prevent and respond to drug-quality problems.
Meanwhile, the report found secondary wholesalers to be the weakest link in the U.S. drug distribution chain. “What we're seeing in the United States—and doubly so in developing countries—is a race to the bottom,” Lawrence Gostin, director of the WHO's Collaborating Center on Public Health Law and Human Rights, said in a news release about the report. “Unscrupulous drug suppliers seek the state or country with the weakest regulatory and law enforcement standards. We need to encourage a status competition for the finest regulatory oversight.”
The IOM recommends that state licensing boards only license wholesalers and distributors that meet the National Association of Boards of Pharmacy accreditation standards, and that the FDA—together with state licensing boards—should establish a public database to share information on suspended and revoked wholesale licenses. It also recommends that Congress authorize and fund the FDA to establish a track-and-trace system that would give each product a unique identifier. Until then, the FDA should set up working groups of stakeholders that include the International Federation of Pharmaceutical Manufacturers and Associations and the Generic Pharmaceutical Association to promote voluntary tracking and tracing for all supply-chain players.
“This new report reiterates what we have long known: the infiltration of our global supply chain with dangerous, illegitimate drugs is a serious public health problem,” Rep. Henry Waxman (D-Calif.), ranking member of the House Energy and Commerce Committee, said in a statement. “California has already passed a law to require individual units of drugs to be accounted for at each step along the supply chain. I hope we can pass a law at the federal level that provides the same level of protection as California's model legislation.”
Last fall, Waxman and other members of the Energy and Commerce Oversight and Investigations Subcommittee questioned FDA Administrator Margaret Hamburg about why the agency didn't do more to prevent a deadly fungal meningitis outbreak linked to a contaminated injectable steroid at the New England Compounding Center in Framingham, Mass. The IOM report cited the company's “negligent production” in the report.
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