Out-Sourcing Pharmaceuticals Can Be Dangerous

pillsPharmaceuticals 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.”

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:

tracy emblem“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.”

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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  1. Linda says

    There is another aspect to this that I have just become aware of. I’m on Medicare, with a Medicare drug plan that I pay for, and I have just exceeded the $2830 in drug costs that places me in the donut hole. To most people, the “donut hole” is a vague concept, but to me, it means the following, for example. Before the donut hole, under my drug plan, I paid $35 for brand name medications (those for which no generic is available). Now, I have to pay $270 per month for one of them, and $110 per month for another. That means I have to somehow come up with an additional $380 per month, on top of all the other bills that I already struggle to pay.

    Would you be able to absorb an additional $380 a month in expenses? And actually, $380 is not an exorbitant amount compared to what other people face.

    So, I felt I had no choice but to turn to a Canadian online pharmacy.

    My doctor recommended one, but they didn’t carry the medication I needed, and someone else I know offered a tepid recommendation for another, saying, “These people haven’t killed me yet.”

    I’ve just placed my first orders. The $270 medication cost $75 for one month, and the $110 one cost $75 for two months.

    Seems like a good deal, doesn’t it?

    I had assumed that the medications that come from Canadian pharmacies are US-made medication that sells for less in Canada. Not so! When I placed the orders, I was told that one will come from a company in the UK and the other will come from a company in India. I find that I’m less concerned about the one that comes from the UK than I am about the one that comes from India. I need the medications, and I can’t imagine the consequences of not having them. On the other hand, I can’t afford what I have to pay here in the US, so the choice is between not having them at all or taking my chances with the ones that come from other countries.

    At least, in my case, I know the origin of my drugs. But, for all I know, that’s where they came from anyway. Wish me luck. I hope for more than “they haven’t killed me yet.”

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