“Made in America” used to be both a sign of quality and a source of pride. But Americans care much more about saving money. That’s why so many of our consumer products—from clothes to electronics to toys—are coming from China and other low-wage countries.
We’ve learned the hard way that such products may not always meet safety standards. Lead in toys, for example, has led to a number of recalls. Toothpaste contaminated with antifreeze alarmed Americans for a few weeks, but not enough to change buying habits.
Most people assume that their medicines are still made in America. Nothing could be further from the truth. Experts estimate that 80 percent of the active ingredients in our prescription drugs come from abroad. Increasingly, this means India and China.
According to Marc Kaufman of the Washington Post, “Neither country has a strong drug regulatory agency.” The former head of China’s Food and Drug Administration was executed a few months ago because he accepted bribes from the companies he was supposed to be overseeing.
Don’t count on our FDA to protect you, though. The U.S. watchdog agency doesn’t have the budget or the manpower to inspect more than a handful of the hundreds of manufacturing plants in Southeast Asia. This year the FDA only plans to visit 13 out of 714 drug firms in China.
Often, FDA officials don’t even know where to look. Some senior FDA officers have said there are 2,100 companies that would need inspection. The Government Accountability Office estimates that nearly 7,000 companies will export pharmaceutical materials into the U.S. in 2007.
What difference does this make? In some cases, manufacturing overseas may meet high standards. A former pharmaceutical industry executive told us that the plants he has seen in India rival those in this country. But there have also been reports of drugs or ingredients being made in sub-standard overseas facilities that manufacture industrial chemicals, with no oversight to prevent contamination.
Generic drugs may be especially likely to contain imported ingredients. The whole point of generics is to save money. To get the price down below the competition, small U.S. generic drug companies may seek the cheapest chemicals abroad and do little testing.
Over the last several years we have received thousands of complaints about generic drug quality. You can read some of the messages by going to www.peoplespharmacy.com. Here is one example:
“I have ventricular fibrillation and have an implanted defibrillator and pacemaker. I was on Cordarone but when the generic came out I was switched over.
“Not long after I started taking generic amiodarone, I started having irregular heart beats and my defibrillator started shocking my heart. About $23,000 later, it was determined that the generic was not working for me and I was put back on Cordarone.
“My doctor had to write letters to the company to get them to permit me the brand name drug, but he could not convince them to give me the generic price.”
We have no way of knowing whether this reader’s generic drug contains ingredients from overseas. But the story indicates the potential hazard that can result if a generic is not identical to its brand name counterpart.