Is it Time for "Country of Origin" Labels on Drugs?Apr 9, 2008 | Parker Waichman LLP
Many wonder why items such as fruit clearly indicate country of origin, but medications do not. In the wake of the recent heparin catastrophe, when hundreds fell ill and dozens died due to contaminated batches of the popular blood thinner sourced from China, consumers and physicians are asking the US Food and Drug Administration (FDA) for better drug labeling.
The FDA requires drug companies to disclose the name and place of business for prescription medication manufacturers, packers, or distributors as well as active and inactive ingredients; raw materials or their origins, are considered "commercial confidential." Most medications are created in laboratories and synthesized from chemicals, but some are made with biological agents such as whale sperm and human blood parts; suppliers can be anyone or anything from a lone fishermen to a giant chemical corporation and one pill may contain dozens of fillers and bulking agents with each ingredient having its own unique, global supply chain.
Drug companies say publicizing would be neither practical nor helpful and that medications sold in the US must meet Good Manufacturing Practices set by the FDA. "The requirements, if it's made in Nutley, NJ, 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. Ensuring these rules are met is up to the companies and the FDA does not have the resources to regularly inspect overseas facilities, where the overwhelming majority—80%—of the active ingredients in US drugs now originate. The Government Accountability Office has long been saying that, at its current rate, it would take the FDA 13 years to inspect each existing foreign establishment only once.
Some wonder if disclosing more information would or would not be beneficial. "The devil is in the details. Would you list the finished product, or the raw ingredient or the raw-er ingredient?" asks Peter Lurie, deputy director of the health research group at Public Citizen. "What level of detail would be meaningful to consumers? asks Karen Riley, an FDA spokeswoman. "What does it mean that most heparin in the world is coming from China and you need heparin?"
Industry executives suggest: Buy from US state-licensed pharmacies you trust and not from online sellers that don't include contact information, don't require a doctor's prescription, or don't bear a seal from the Verified Internet Pharmacy Practice Sites (VIPPS). Examine pills. "There should be no chips. Any embossing should be centered and properly done," says Wayne Pines, a former FDA spokesman and current drug company consultant. Watch out for changes in color, taste, or smell and ensure "tamper-evident" packaging is intact. Misalignments or sticky residue can indicate a seal has been broken and replaced. When taking medication, monitor how you feel. If your drug isn't working they way it is supposed to, let your doctor know.
The House Energy and Commerce Committee is reworking a bill to increase FDA's inspections overseas and is considering requests to require drug labels to list country-of-origin, at least for active ingredients.