Don’t Allow Foreign Pharmaceutical Facilities to Send us Tainted Drugs

Health, Petitions — By on January 19, 2012 7:00 am

Target: The US Food and Drug Administration (FDA)

Goal: To establish mandatory FDA inspections of all drug production facilities located overseas that contribute to pharmaceuticals sold in the US.

A new report issued by the US Government Accountability Office reveals that most drug ingredients and nearly half of all pharmaceuticals sold in the US are manufactured overseas in facilities that have never been inspected by the US Food and Drug Administration.  American citizens are consuming outsourced and unregulated drugs with ingredients that are sourced by unknown suppliers. As a result, the outbreak of serious illness or even death due to tainted drugs becomes a possible reality. In order to ensure our safety, the FDA must inspect all drug production facilities, including the thousands overseas being used to produce American pharmaceuticals.

According to the new report, nearly 40 percent of all pharmaceuticals sold in the US are manufactured in overseas facilities, and a whopping 80 percent of all ingredients used in the manufacturing of drugs, including those produced in the US, also come from foreign factories. More shocking, is the mere 11 percent inspection rate of these foreign manufacturing plants by the FDA. The ridiculously low inspection rate not only demonstrates US leniency, but it becomes a contributor to the alarming sickness and death outbreaks caused by tainted drugs. For example, it was reported by the Counterfeit Drug Incident Encyclopedia that in 2008 tainted heparin produced in India with a main ingredient sourced from somewhere in China, contributed to the death of 81 people and resulted in hundreds of allergic reactions in the US. And since most drug producers view their supply chains as trade secrets and are not required to disclose supplier information, the true sources of the drug’s ingredients are very difficult to discover.

It is impossible for the FDA to protect American consumers if it does not establish mandatory inspections of foreign pharmaceutical facilities. Unknown suppliers and illegitimate manufacturers should not contribute to the drugs sold in the United States. By signing the petition below you will help force the FDA to inspect and investigate all overseas facilities used in the production and supply of US pharmaceuticals.

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Dear US Food and Drug Administration,

Allowing the distribution of pharmaceuticals from unregulated foreign manufactures endangers the life and well-being of countless Americans.  It is ridiculous that only 11 percent of overseas drug manufacturers have been inspected when they contribute to nearly half of all drugs sold in the United States.

This absurdly low inspection rate not only shows a high level of leniency, it opens the door for tainted drugs to enter into the US pharmaceutical industry. In 2008, tainted heparin was linked to 81 deaths and resulted in hundreds of severe allergic reactions in the US.

I am urging you to establish mandatory inspections of all foreign drug production facilities that contribute to pharmaceuticals sold in the US. In order to better protect our health, action must be taken to restrict the influx of outsourced and unregulated drugs and their ingredients.

Sincerely,

[Your Name Here]

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Signatures

  • Alan Haggard
  • anne westerman
  • Monika Huber
  • Shane Cummings
  • Linda Muntner
  • Patricia Lindsey
  • Brendan Pearse
  • mary Hebblewhwite PhD and Paul Davidson MD
  • mary Hebblewhwite PhD and Paul Davidson MD
  • Elizabeth O'Halloran
  • Katherine Head
  • sue harrington
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