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Recently, Diane Rehm had a show about prescription drugs sold in the U.S. that are manufactured outside of the U.S.  Unknown to me (and probably many others) many of the prescription drugs that we take were actually manufactured outside of the United States.  According to Dr. Margaret Hamburg, Commissioner of the FDA:

Eighty percent of the active pharmaceutical ingredients in drugs taken here are actually manufactured in other countries and about 40 percent of the finished drugs are coming from other countries.

Among the countries mentioned in the program as major suppliers are China and India.

The one positive thing that I heard on the show was that the FDA does have the power to inspect these plants in other countries and has in fact being doing so.  Unfortunately, it appears to me that the FDA does not have sufficient resources to deal with the problem.

According to Gardiner Harris, a reporter for The New York Times:  

[T]here are basically two issues here and Dr. Hamburg, as good as she is, can only address one of them. There is the safety issue which how safe are these drugs considering that we haven't been there. Some of these suppliers in China, frankly Dr. Hamburg's people have not gone into in 10 to 15 years. What she did not say to you was that she has not gotten anywhere close to visas out of the Chinese government that the FDA wants. The FDA's been asking for those additional visas for two years. The Chinese government has refused to give them to the FDA, or at least has not given them to the FDA.

Without inspections, we cannot be sure of the safety of the drugs we are taking.  Another guest on the program, Allen Coukell of the Pew Charitable Trust, provided an example of where people were harmed because of these unsafe drugs:

And beginning a couple of years ago in the wake of a tragic contamination of a blood thinner called Heparin, we [Pew] became involved in the issue. And that was a case where the drug was coming from China. Someone in the upstream supply chain of that drug substituted something that was not the correct active ingredient but tested like the correct active ingredient. Made its way all the way into the drug and into the U.S. supply chain and made large number of patients quite sicknd that was pretty clearly a deliberate adulteration for economic reasons. So that was not just...

That was not just a case of a lapse in quality standards. That was somewhere somebody deliberately substituting a low-cost ingredient for economic gain.

Also scary was this comment by Harris:

But a second and arguably just as important issue is the security issue. What she did not also say is that we're getting all of our antibiotics from China right now. We are getting all of our steroid medicine -- if you go down the list of medicines that are absolutely essential in hospital settings, and nearly all of them have their crucial ingredients coming from China, were we to get into a bad situation with China and some of these imports were to stop, our health care system would collapse fairly quickly. And no one is addressing this.  The last antibiotic plant in the United States was up in Syracuse, New York. It closed in 2004.

The entire program is worth listening to (or reading the transcript).  You can listen to the program by selecting "listen" here:

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