Drugs – Country of Origin and Safety

Are the pills you take as safe as the food you eat? I can peel my imported fruit but I must swallow my pills without washing or peeling.

There was an interesting article in the Wall Street Journal about the country of origin of pharmaceutical ingredients.

“Indeed, the FDA requires drug companies to disclose only the name and place of business of the manufacturer, packer or distributor of prescription medications. Active and inactive ingredients must be listed on the label, but not the raw materials or their origins, which are considered “commercial confidential.”

Since the FDA does not have the resources to inspect all overseas facilities that manufacture ingredients, it is up to the pharmaceutical companies to ensure good manufacturing practices. The recent contamination found in the blood thinner heparin supplied by China shows that this system does not always work.

According to a recent article in the New England Journal of Medicine (NEJM) Trying Times at the FDA – The Challenge of Ensuring the Safety of Imported Pharmaceuticals by Stuart O Schweitezer, Ph.D

“This sort of problem should theoretically have been prevented by the FDA, which inspects foreign factories producing drugs and chemical components that are intended for export to the United States. Investigations are continuing, but preliminary information shows that the FDA did not inspect the plant, though it had intended to do so. The FDA’s program for inspecting foreign drug manufacturers has been swamped by a rapid increase in overseas manufacturing of both finished drugs and chemical components. The FDA has a mandate to inspect producers of both drugs and chemicals used to manufacture drugs (active pharmaceutical ingredients, or APIs) in order to certify that plants meet the current Good Manufacturing Practice (GMP) standards. Data on the number of foreign drug and API manufacturers are difficult to obtain. The FDA uses two databases listing foreign plants that are subject to inspection. According to a 2007 report by the Government Accountability Office (GAO), one database lists approximately 3200 establishments, whereas the other lists 6800.3 Even if the smaller number is accurate, the agency inspects only approximately 7% of foreign establishments in a given year, meaning that it could take at least 13 years to inspect them all — once. The FDA cannot say how many foreign plants have never been inspected.”

The pharmaceutical industry is increasingly using foreign plants and ingredients. The burden on the FDA to ensure that the drugs we take are are safe and pure is daunting. So what is the solution to this problem?

In a recent NEJM article Allastair J.J.Wood M.D. has a very reasonable suggestion.

“We need to acknowledge that ensuring the safety and integrity of our food, drugs, cosmetics, and medical devices is primarily the responsibility of manufacturers, with the FDA providing a regulatory framework and oversight. It is also critical that legislators recognize their responsibility to provide the agency with funding that is adequate for it to perform its important functions.”

“No longer should manufacturers be able to imply that inadequate FDA inspection is an excuse for adulteration of their product during manufacture. We must stop allowing the game of “kick the FDA” to be risk-free to participants. The public’s health is at stake, and the time for adequate federal funding of the FDA is now.”

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