27 Oct An ever-increasing number of drugs and drug ingredients are manufactured outside the United States. In February 2008 there was a drug controversy regarding heparin (an anticoagulant or blood thinner). In 2008, Baxter, who supplied half of the heparin in the U.S.
An ever-increasing number of drugs and drug ingredients are manufactured outside the United States. In February 2008 there was a drug controversy regarding heparin (an anticoagulant or blood thinner). In 2008, Baxter, who supplied half of the heparin in the U.S. announced it would discontinue its heparin product. This was because over 800 allergic reactions and 60 deaths had been associated with the product. It was later found the active ingredient Baxter obtained from a Chinese manufacturing plant was contaminated. The FDA approved the Chinese company without inspecting it because it confused the name with another Chinese manufacturing plant that had already been inspected. Per a CNN news report in 2008, “The U.S. FDA inspects only about 7 percent of foreign drug makers each year; it failed to inspect the Changzhou SPL because of what it says was a language mistake.”
An ever-increasing number of drugs and drug ingredients are manufactured outside the United States. In February 2008 there was a drug controversy regarding heparin (an anticoagulant or blood thinner). In 2008, Baxter, who supplied half of the heparin in the U.S. announced it would discontinue its heparin product. This was because over 800 allergic reactions and 60 deaths had been associated with the product. It was later found the active ingredient Baxter obtained from a Chinese manufacturing plant was contaminated. The FDA approved the Chinese company without inspecting it because it confused the name with another Chinese manufacturing plant that had already been inspected. Per a CNN news report in 2008, “The U.S. FDA inspects only about 7 percent of foreign drug makers each year; it failed to inspect the Changzhou SPL because of what it says was a language mistake.” http://www.nbcnews.com/id/24015019/ns/health-health_care/t/heparin-probe-reveals-global-drug-market-perils/#.XPCau4hKiUk
Research what kinds of safeguards there are for FDA-approved drugs manufactured elsewhere.
For example, if a generic drug is labeled “ibuprofen” and is sold in the United States, does that mean it was manufactured in the US? If not, how do we know it is manufactured correctly and safe?
What are your thoughts about drugs manufactured in another country?
Research the percentage of drugs or active pharmaceutical ingredients (API) manufactured outside the US.
Do you think companies should be required to disclose where the ingredients in their drugs are manufactured?
Is the FDA doing more inspections today than they did in 2008 to guard against problems happening again? Cite research.
Cite an example of a problem that has occurred with an FDA-approved and inspected drug or drug ingredients (API) manufactured somewhere other than the United States.
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