Report: Action Needed To Curb Fake And Substandard Drugs

A blue-ribbon panel is urging stronger regulation of pharmaceuticals around the world to combat the growing problem of fake and poor-quality medicines.

Both the quality problems and the danger of fraudulent medicines also affect Americans.

Fungal contamination of steroids made by a Massachusetts pharmacy, which sickened more than 700 Americans and killed 46, is one recent example of these substandard drugs. Other U.S. patients have been the victims of fake cancer drugs and medicines obtained over the Internet that had little or no active ingredient.

The problem extends to more than 120 countries, the Institute of Medicine report says, and has done incalculable damage to efforts to control tuberculosis, malaria, AIDS and other diseases.

No one knows exactly how big the problem is, but Lawrence Gostin, chairman of the IOM committee that issued the report, says it's been getting steadily worse. "Whatever the magnitude is, it's huge and growing," he tells Shots.

The National Academies of Science, of which the IOM is part, was commissioned by the Food and Drug Administration to look at how to protect people against fake and substandard drugs.

The root cause for the problem is that there's so much money to be made. "It's actually more profitable to supply illegitimate drugs than cocaine or heroin," Gostin says. "And so you're seeing more and more sophisticated drug suppliers."

The report is replete with scandals and horror stories — some previously publicized, others obscure:

"What we're seeing in the United States — and doubly so in developing countries — is a race to the bottom," Gostin says.

The panel says the U.S. Congress needs to authorize the Food and Drug Administration to trace the authenticity of medications from raw ingredients to manufacture and through the distribution chain all the way to retail pharmacies.

The 300-page report also calls on the FDA to work with state licensing boards to regulate and report pharmacies like the problematic Massachusetts firm, and launch a national database to report violators.

On the international level, the IOM panel calls on the World Health Organization to develop a global code of practice for pharmaceuticals. Among other recommendations is that the World Bank and other agencies provide low-interest loans to medium and small pharmaceutical companies in developing countries to beef up their equipment, supply chain and quality-control systems.

Copyright 2013 NPR. To see more, visit http://www.npr.org/.