How Safe Are Generic Drugs?

Beginning in 2007, tainted heparin (a blood thinner) imported from China was linked to the deaths of 149 American patients. It was a stark example of a growing problem. China is now the largest supplier of pharmaceutical chemicals—hundreds of tons annually—to the world…

Five clinical studies published in the U.S. and abroad show that copycat versions of imatinib mesylate, a leukemia drug, lead to a higher risk of fatality. French researchers found that the composition of 21 of 30 different copies of the chemotherapy drug Taxotere were outside of approved specifications. And for the past four years, a group of researchers working with me has sampled over 2,000 products from emerging markets. About 5% were substandard—either due to suspect or under-dosed ingredients, or to inappropriate formulations that made the correct ingredients insoluble. (The detailed results have just been published in the British journal Pharmacologia.)

See full WSJ editorial by Roger Bate.

Comments (5)

Trackback URL | Comments RSS Feed

  1. Devon Herrick says:

    China is a supplier of some type of chemical in about 80% of the drug supply chain. In the case of the blood thinner heparin, the odds that the contaminant was accidental are zero! The additive found in heparin passed chemical tests for the active ingredient in heparin. Yet, the additive cost one-tenth as much as the real active ingredient. That’s an example of intentional adulteration. If China wants to continue supplying the world with chemicals for pharmaceuticals it will have too better police the chemical supply chain and punish those who pass off fake or inferior products.

  2. Brian Williams. says:

    Didn’t China execute the head of their FDA for something like this?

  3. Kennedy says:

    I hope this problem doesn’t grow, and that it doesn’t end up serving as an excuse for yet more government regulation.

  4. Virginia says:

    Surely there is something that drug companies can do to assure the integrity of their supply chains?

  5. Jesse_EngAmer says:

    This is just further proof that the FDA is an inefficient and ineffective organization. With the 2011 Food Safety and Modernization Act the FDA intends to regulate more closely the foreign drug and food facilities from which we import our goods, a monumental undertaking, to put it modestly. The FDA admitted in their report Pathway to Global Product Safety and Quality it would take 9 years just to inspect every high-priority pharmaceutical facility alone. They have neither the funding nor resources for such a task as it is. Yet the FDA isn’t giving such a pressing and dangerous issue it’s full attention as it continues to spread its resources thinner and thinner, over-regulating across various campaigns. Stemming the flow of dangerous imported pharmaceuticals should be its main priority, not the salt in Campbell’s soup or the calories in movie theatre popcorn, not dietary supplements or energy drinks, but this.