Hearing that something was "Made in the U.S.A." makes many people feel confident in the product ... especially when it's something you ingest! In fact, more than three out of four voters are confident that prescription drugs made in the USA are free from drug contamination, while fewer than one in 10 feel confident about medications made in India or China, according to a poll released today by the Pew Charitable Trust's Prescription Project. But how do you know that your medication didn't come from one of those countries?
Unbeknownst to many Americans, an estimated 80% of the substances used to make or package drugs sold here are made in other countries, says Allan Coukell, a pharmacist who directs the medical safety portfolio for the Pew Health Group. And a growing proportion come from India or China. In 2007, 68% of ingredients of drugs sold worldwide came from India or China, vs. 49% in 2004.
Not that consumers can tell where medications were made, Coukell says: "When you buy a shirt, it will say right on the label where it was made, but when you get a pharmaceutical, you don't know."
Monitoring far-flung plants presents a logistical challenge to the Food and Drug Administration, Coukell says. "They clearly don't have the people or the resources they need to oversee manufacturing the way it exists today."
In 2007 and 2008, more than 100 patients in the USA died after taking heparin made with a contaminated active ingredient from China.
Complicating matters is the FDA's inability to order recalls of batches of drugs that might pose a risk, Coukell says. (The FDA can withdraw approval of a drug, taking it off the U.S. market entirely.)
Even so, drug recalls soared 400% from 2008 to 2009, which saw a record 1,742, according to the Drug Safety and Accountability Act of 2010, to be introduced today by Sen. Michael Bennet, D-Colo. Bennet's bill would empower the FDA to order recalls of unsafe batches of drugs.
According to the Pew random nationwide survey of 802 registered voters, 55% say the government should do more to ensure the safety of drugs made in other countries, and nearly nine in 10 back legislation to implement new drug safety measures.
"Brand-name pharmaceutical companies make tremendous investments in quality-control systems," Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, a prescription-drug trade group, said in a statement. "The U.S. regulatory system for prescription drugs is the toughest and safest in the world."
In an interview, Bennet said McNeil Consumer Healthcare's recall this year of more than 130 million bottles of over-the-counter children's medicines fueled his concerns. Referring to his daughters, ages 10, 9 and 6, he said, "I want to make sure any pharmaceuticals they're ingesting are safe."
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