April 09, 2008 - FDA Asked for Better Labeling Following Heparin Deaths

April 9, 2008 - In the wake of the recent Heparin catastrophe, in which at least 103 people died after receiving contaminated Heparin, according to latest reports from the FDA, the regulatory agency is being asked by both consumers and physicians for more stringent labeling requirements. Since the beginning of the year, more than a hundred people have died and dozens more have suffered life-threatening reactions to contaminated doses of the blood-thinner Heparin, which is manufactured in China. One of the pharmaceutical companies who markets the drug, Baxter International, conducted a recall earlier this year, and found the contaminant over-sulfated chondroitin sulfate in some of the recalled vials. Another maker, APP Pharmaceuticals, reports that it has identified no illnesses or deaths linked to its product.The FDA is investigating to determine the source of the contamination.

Drug companies are currently required to disclose the name and place of business of the manufacturers, packers, and distributors of prescription medications, as well as the active and inactive ingredients. Both the raw materials and their origins, are considered “commercial confidential.” Most medications are created in laboratories where they are synthesized from chemicals, but some are made with biological agents such as pig intestines, the source of Heparin, whale sperm and even human blood parts. The suppliers of biological raw materials can be anyone or anything from one individual person to a giant chemical corporation, and a single pill may contain dozens of different fillers or bulking agents, each having its own unique global supply chain.

The pharmaceutical companies say that it would be neither practical nor helpful to publicize the source of all of the raw materials used in the manufacturing process, and that in any event, all medications sold in the US must meet the 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. Unfortunately, it is up to the individual companies and the FDA to ensure that these guidelines are met. The FDA does not have the resources to inspect overseas facilities, where the majority - approximately 80% - of drugs sold in the United States are now manufactured.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 one time.

Some, however, question whether disclosing more information would be be beneficial. “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 if you need Heparin?”

Industry executives make the following suggestion: 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 the way it's supposed to, let your doctor know.

The House Energy and Commerce Committee is reworking a bill that would increase the FDA’s inspections overseas, and is considering requests that it begin to require drug labels to list country-of-origin, at minimum, for the active ingredients.

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