A new report released from an Institute of Medicine panel on Wednesday says that the problem of counterfeit, contaminated and adulterated drugs is global and requires a better international regulatory system, as well as big investments in the FDA and in developing a high-quality drug industry in developing countries.
The report comes on the heels of 46 American deaths due to an outbreak of fungal meningitis linked to contaminated steroids sold by a Massachusetts pharmacy. The report also calls for a track and trace system that would keep tabs on drugs – something experts have been demanding for years, but Congress has yet to put into effect.
In addition, the report says that the FDA needs to organize a tighter system for regulating pharmacies, and that the World Health Organization must lead and coordinate an international effort to set and enforce standards.
“It has been a really eye-opening experience over the last year,” said panel chair, Dr. Lawrence Gostin, a professor of global health law at Georgetown University Law Center.
According to Gostin, experts in a variety of fields – including pharmacy, drug security, international development and global health – held briefings worldwide to investigate the problem and develop a list of recommendations, which call for major reform in the U.S.
“It should have happened years ago,” Gostin said in a telephone interview. “The United States sets a model for the world. I think it’s critically important."
Although the risks from fake, contaminated or thinned-down drugs are much worse overseas, the ramifications still affect the rest of the world, including the U.S., because an estimated 80 percent of the active ingredients used in U.S. drugs are made in other countries.
Thinned-down drugs, for example, can promote resistant germs and parasites – leading to outbreaks like drug-resistant tuberculosis and malaria, according to the report.
The Institute of Medicine, an independent group that advises the federal government, says it’s impossible to impossible to gauge the scope of the problem.
“Deaths from fake drugs go largely uncounted,” the report says.