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FDA inspection of foreign drug makers: April Fool's joke?

No Fooling

Here’s an April Fool’s joke you can play on a friend tomorrow

You: Did you hear that 60 percent of all drugs used in the U.S. are manufactured in other countries (such as China), but last year the FDA inspected less than 10 percent of the 200 Chinese facilities that produce drugs for the U.S.?

Your friend: What! That’s outrageous!

You: April fool!

Your friend: Aw you got me.

Okay, admittedly, that’s not quite the snappiest April Fool’s joke ever, but it does have a snappy kicker – all those numbers are way off:

1) 80 percent of all drugs used in the U.S. are manufactured in other countries
2) There are more than 560 Chinese facilities that produce drugs sent to the U.S.
3) The FDA inspected less than 3 percent of those facilities last year

No fooling.

Not the firstnot the last

Sometimes I wonder what the scene is like around FDA headquarters. I imagine it must be similar to Sheriff Andy’s office in Mayberry.

Stranger in town: I’d like to report an adverse reaction to a drug.

Andy: You look fine to me, friend, but have a seat and I’ll get an adverse reaction form for you to fill out. I reckon Barney’s got one around here somewhere.

Serious adverse reactions were recently linked to heparin, a blood-thinning drug linked to nausea, lowered blood pressure, shortness of breath, and nearly 20 deaths. Baxter International is the source of the heparin that’s caused these problems, and according to the Associated Press, Baxter’s primary supplier gets most of its heparin from China.

This is by no means the first time that China-supplied drugs have been the cause of deaths. And according to former FDA deputy commissioner William Hubbard, it won’t be the last. He told the New York Times: “It’s going to keep happening until Congress fixes the problem.”

It appears that the hidden message here is that the agency is incapable of fixing itself. But I’m not sure exactly WHICH Congress Mr. Hubbard believes might step in to fix this and other safety problems we’ve seen with prescription drugs. It sure isn’t the U.S. Congress, whose members receive lavish attention and campaign contributions from drug company lobbyists who are as generous as the law allows.

Pay the piper

An FDA spokesperson told the Times that the agency is “looking at a number of options” in order to increase its presence in countries that produce our drugs. But money allocated to the FDA by Congress is on the wane, not increasing. So that can only mean one thing: Time for user fees!

Oh brother. That’s a perfect plan if you want to spread a lot of money around while accomplishing little or nothing. With this arrangement (currently being considered by Congress), foreign drug makers would be required to give money to the FDA to underwrite the inspection process. Yeah, no possible conflict of interest there!

The FDA already has a user fee system in place for the approval of new drugs. So drug companies are essentially paying the salaries of FDA personnel who green-light or reject new drugs. And we’ve seen just how woefully ineffective the FDA has been in ensuring drug safety with that system.

Sowhere are we? We now know that a large majority of prescription drugs are not made in the U.S. And we now know that foreign drug makers are rarely if ever inspected. And to cap it all off, the Times notes that the very few spot inspections of foreign facilities that do occur are done with advance notice. FDA officials claim advance notice must be given because of logistics.

Logisticsbut in terms of safety, zero logic.

“China, US Probe Heparin Blood Thinner” Henry Sanderson, The Associated Press, 3/16/08,
“Tainted Drugs Put Focus on the F.D.A.” Gardiner Harris, The New York Times, 3/17/08,