Problems with drug imports in recent years, most notably contaminated heparin from China that resulted in the deaths of 19 individuals, has led to growing calls for the government to mandate country of origin labeling (COOL) for pharmaceuticals.
Today, the Food and Drug Administration (FDA) requires drug companies to disclose the name and place of the manufacturer or distributor of prescription medicines along with a list of ingredients (active and inactive). Raw materials, however, are not listed.
Companies involved in the pharmaceutical business contend that including a listing and source of raw materials is impractical and would not improve the overall safety of the supply chain. All drugs sold in the U.S., COOL opponents point out, must conform to Good Manufacturing Practices set by the FDA.
"The requirements, if it's made in Nutley, N.J., or a foreign country, are exactly the same," says Lori Reilly, vice president for policy and research at Pharmaceutical Research and Manufacturers of America, told The Wall Street Journal.
The problem, contend critics of the present system, is that neither pharmaceutical companies nor the FDA do a sufficient job of inspecting overseas factories. Raw materials or finished product that come into the U.S. are assumed to meet manufacturing guidelines.
According to The Journal article, 80 percent of active ingredients used in U.S. prescription drugs now come from facilities outside the country. The House Energy and Commerce Committee is looking at amending a bill to increase the number of inspections the FDA conducts of overseas factories as well as adding requirement for COOL for active ingredients in drugs.
The FDA has not come out in support of new labeling requirements.
"What level of detail would be meaningful to consumers," Karen Riley, an FDA spokesperson asked The Journal. "What does it mean that most heparin in the world is coming from China and you need heparin?"
Discussion Questions: What would you say is the level of confidence that American consumers have in the combined safety and effectiveness of prescription medicines sold in retail pharmacies today? Is a country of origin labeling requirement for active ingredients in pharmaceuticals something the retail industry should support?