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Out-Sourcing Pharmaceuticals Can Be Dangerous

Tracy Emblem: Up to 40% of the drugs Americans take are now imported, and up to 80% of the active pharmaceutical ingredients in drugs are manufactured by companies in foreign countries.

Pharmaceuticals Manufactured in China and India


Most Americans would be shocked to learn that India and China have become main suppliers of low-cost drugs and drug ingredients. Up to 40% of the drugs Americans take are now imported, and up to 80% of the active pharmaceutical ingredients in drugs are manufactured by companies in foreign countries.

By 2013, China is expected to be the third largest pharmaceutical market in the world and India is close behind China because the U.S. is India's top export customer.

Foreign manufacturing of our nation's drugs poses a risk to consumers because the Food and Drug Administration rarely conducts quality-control inspections in foreign countries.

In June 2007, the Washington Post reported: "Over the past seven years, amid explosive growth in imports from India and China, the FDA conducted only about 200 inspections of plants in those countries, and a few were the kind that U.S. firms face regularly to ensure that the drugs they make are of high quality."

These foreign markets allow clinical trials and drugs to be developed cheaper, but does it come at a sacrifice to safety?

According to Chemistry Manufacturers & Affiliates, many active pharmaceutical ingredients that are produced in foreign facilities are rarely inspected by the U.S. Food and Drug Administration, especially ingredients used in over-the-counter drugs.

Consumers do not know if a medication or its ingredients was produced abroad because there is no country of origin labeling requirements.

NBC News recently reported that Glaxo-Smith-Kline has agreed to pay $750 million to settle a Justice Department's claim that the company sold adulterated and improperly made drugs produced by its former drug manufacturing plant in Cidra, Puerto Rico. GSK's subsidiary agreed to plead guilty to allegations that "the plant churned out medications that were mislabeled, mixed up in the wrong packaging, and even defective -- made either too weak or too strong. The defects affected such popular prescription drugs as the antidepressant Paxil and the ointment Bactroban, used to treat skin infections."

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In June, Pfizer recalled three I.V. products manufactured in India after floating matter was found in plastic IV bags.

Who can forget the deaths and allergic reactions that occurred when contaminated heparin, used to thin blood, was produced in China and sold in the U.S. The New York Times reported that people had difficulty breathing, and suffered nausea, vomiting, excessive sweating and rapidly falling blood pressure. In some cases the defective heparin led to life-threatening shock.

Years ago, Congress was forewarned that foreign drugs foisted on the public might not be safe. In 2003, William Hubbard, an associate commissioner of the FDA testified before a subcommittee of the House Committee on Government Reform. He explained the public health threats posed by the importation of unapproved, adulterated and misbranded drugs, as well as counterfeit drugs from foreign and domestic sources.

Unfortunately, Congress ignored the testimony and has been increasingly willing to let pharmaceutical companies out-source our nation's drug supply.

The out-sourced drugs may be expired, subpotent, contaminated or counterfeit product, a contraindicated product, an incorrect dose, or a medication which is not accompanied by adequate directions for use. Consumers then face risks of dangerous drug interactions and other serious health consequences.

Out-sourcing drugs is a supply-safety risk too. For example, when the heparin outbreak recalls were unexpectedly announced, there were serious concerns about whether we would have enough heparin to meet patient needs as a result of the contamination.

National security is an important component in considering the continued practice of out-sourcing our nation's drug supply. In December 2007, an article in the Kansas City Star reported:

"Consider this scenario: If a major anthrax attack were to occur in the United States - larger than the one in 2001, when five people died - pharmaceutical companies that make the two antibiotics most suitable for treatment, Cipro and doxycycline, would have no choice but to rely on China or India for key ingredients once American stockpiles were exhausted. Those ingredients no longer are made in the West."

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If this is true, where has Congress's oversight been hiding during the wholesale outsourcing of the nation's drug supply?

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