How Many Decades Will It Take to Fix FDA?

[Celebration]

http://www.humanevents.com/article.php?id=25124#continueA

The unfolding tragedy in which four Americans have died in the last two months and about 350 others have suffered adverse reactions after being injected with Chinese-made heparin -- a blood-thinning drug -- has its roots in a spectacular example of bad government that some federal watchdogs started barking at a decade ago.

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In 1998, after investigating the Food and Drug Administration's procedures for inspecting foreign factories producing drugs for import into the United States, the Government Accountability Office told Congress the system put Americans at risk.

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GAO had discovered two internal FDA documents -- a 1988 "internal review" and a 1993 "internal discussion paper" -- that indicated the agency knew it had problems monitoring the safety of foreign-made drugs.

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Nor was the Reagan doctrine of "trust but verify" applied to foreign drug makers in places such as the People's Republic of China. Managers of a U.S. facility where a problem was discovered had to fix it and face re-inspection; managers of a foreign facility simply had to give their word they would fix it.

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Most remarkably, the FDA does not bring its own translators on foreign inspection tours or hire independent translators to accompany its inspectors to foreign drug-making facilities. Instead, it relies on English-speaking officials at the factories being inspected to tell them what is going on.

[Celebration]

1. Flood of Drugs, Little Oversight

http://www.chicagotribune.com/features/lifestyle/health/chi-sun_baxter-heparin-baxmar02,1,7846258.story

By the time St. Louis Children's Hospital called in its infectious-disease specialist Jan. 4 to diagnose a mysterious spike in allergic reactions to kidney dialysis, it was clear there was a major problem.

Three patients had become ill after taking the blood-thinning drug heparin. One had developed the same reaction during a dialysis treatment in November. Minutes after dialysis needles punctured their veins, the boys' lips and eyelids swelled. Their blood pressure dropped, and their heartbeats raced at dangerous levels.

When infectious-disease specialist Dr. Alexis Elward homed in on the problem -- putting high on her list the drug made by Baxter International Inc. of Deerfield -- she became the first doctor to alert the Centers for Disease Control and Prevention. It wasn't until late in February, though, that Elward and others learned that no U.S. or Chinese government inspectors had visited the Chinese plant that produced the drug now linked to more than 400 illnesses and as many as 21 deaths across the U.S.

[Buzz Clik]

2. I believe the phrase goes like this: You can't fix stupid.

If Congress and the White House decide to work together on this, it might happen some day.