A Cautionary Tale

Yesterday, I read an indepth article about the Food and Drug Administration that I believe highlights why we should be careful when reforming government agencies.

The article tells the story of how the FDA has shifted from drug monitoring to drug approval as it's main mission.

Back in 1992, the FDA had it's own scientists it could go to when there was a suspicion that there was a problem with a certain drug. That has become non-existent over the last 12 years.

And the reason isn't because of anything malicious. What happened was that during the height of the AIDS crisis, one of the main complaints was the speed of drug approvals. It could take years for drugs to make it to the market.

In order to address this situation, a deal was reached with the drug companies in which they would help pay for the approval process. This would enable the FDA to devote more resources to the approval process. However, there was a caviate in the agreement that has had detrimental effect on the FDA. The FDA was required, as part of the agreement, to spend a certain portion of it's budget on drug approval. This soon led to the FDA raiding other parts of it's budget in order to meet it's obligation.

This is one of the reasons why it was Merck and not the FDA who came out with the information that lead to Vioxx being pulled from the market.

There is more information in the article from the New York Times and I encourage all to read it.

One reason I am posting this is the debate over the 9-11 Commission recommendations. I have not really been certain that the creation of an intellegence Czar will lead to more effective intellegence gathering. I am not arguing that the bill shouldn't be passed. But, it seems that when a reform is rammed through Congress, we end up doing more harm or really just creating an illusion of having done something. Witness the Patriot Act, Homeland Security, Medicare prescription Drugs, etc etc.

Even a small change such as funding for the FDA can lead to grave consequences.