WHY YOU CAN'T TELL WHERE YOUR MEDICATION WAS MADE
April 9, 2008
Consumers and physicians are asking why pharmaceuticals aren't labeled with their country of origin since the deaths of 19 people in the United States were linked to contaminated batches of heparin from China, says the Wall Street Journal.
- The Food and Drug Administration (FDA) requires drug companies to disclose only the name and place of business of the manufacturer, packer or distributor of prescription medications.
- Active and inactive ingredients must be listed on the label, but not the raw materials or their origins, which are considered "commercial confidential."
- Most modern medications are synthesized from chemicals in laboratories, but some include biological agents as diverse as whale sperm, and human blood parts.
- Suppliers range from itinerant fishermen to giant chemical companies.
- Besides the active ingredients, a single pill may include dozens of fillers and bulking agents, each of which has its own global supply chain.
Drug companies say making such information public would be neither practical nor helpful to consumers, and that what counts is that any medication sold in the United States must meet 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, a drug-industry trade group.
But ensuring that those rules are met is up to the companies:
- The FDA doesn't have the resources to regularly inspect overseas facilities, where 80 percent of the active ingredients in U.S. drugs now originate.
- The Government Accountability Office says that at the current rate, it would take the FDA 13 years to inspect each existing foreign establishment once.
- The House Energy and Commerce Committee is reworking a bill that would ramp up the FDA's inspections overseas and is considering calls to require drug labels to list country-of-origin for active ingredients.
Source: Melinda Beck, "Why You Can't Tell Where Your Medication Was Made," Wall Street Journal, April 8, 2008.
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