Thursday, October 22, 2009

What? The FDA and disorganized? But, how can that be...?!!

Yes, how can that be, since the Democrats, in their infinite wisdom, decided to shore up a faltering agency by dumping money and responsibility (read tobacco) on it?

What the hell am I going on about? Well, the New York Times came out with a story today about how Congressional investigators (and who exactly are these people? Are they the same ones also doling out my taxes to the FDA on the side?) have concluded that the FDA is disorganized, inept and derelict.

Don't simply say "What's new about that?" and move on.

The prelude

Apparently, aside from regulating Food, Drugs, Devices and now Tobacco (because it is food, I guess), the FDA must also punish fraudulent investigators. Now that's a tall order, especially considering that the FDA has already demonstrated unparalleled ability in the following areas:

1. Failure in the regulation of food
2. Failure in the regulation of drugs
3. Failure in the regulation of devices

In May, when the Obama administration was bringing gifts to Maryland, I lamented, along with several others on the need for the break-up of the FDA:

Of course, no one in the Obama Administration wants to listen to you, unless you get on Fox TV and shout yourself hoarse. Some grass roots.

Anyhow, ours is not to ask, but to damn.

The problem:

The FDA is an overburdened organization with entrenched leadership. A bus load of NIH scientists and a truck load of cash will not solve the problem. Joint regulation of food, drugs, devices, tobacco, researchers and everything in-between is ridiculously infeasible.

While it is easy to make light of the FDA's failures, there is a reason why this problem happens:

1. The FDA has to take care of everyone of it's current burdens of making policy, coming up with regulations that enforce policies and rulings, report to Congress, etc.

2. The FDA has to deal with a global economy that results in devices and drugs manufactured in an an array of nations across Asia and Europe. The FDA needs to deal with fraud, counterfeit operations and GMP, GCP across the globe for anything used in the US.

3. The FDA is constantly dealing with issues and situations that have never been faced before. They need to hire and rely on outside "experts", who are usually non-existent. If they do exist, or thrust themselves in as subject matter experts, these experts usually come burdened with conflicts of interest.

All said and done, the main problem is an in-cohesive attitude towards the FDA, it's capabilities, the limitation and most of all, Congress doesn't really seem to care about action either.

While the last eight years were no party, I squarely blame the Obama administration for simply ignoring straightforward facts - the FDA is, er, "messed up".

Replacing a few embattled leaders doesn't mean much. It needs a thorough scrounging, from the inside out.

Reform the FDA

Reforming the FDA is not so tough:

1. Separate food, drug and device administrations into three separate federal organizations. Have the HHS directly, or through the CDC make sure they co-operate with each other. Or get a Czar, or a Don...whatever, just make it happen.

2. And yes, I may not be smarter than a 5th grader, but I do know that devices and drugs may sometimes be combined or classified differently. Fine - make sure that the agencies pick 50-50 on the committee for such special conditions and "deal with it". When Newton discovered gravity, people didn't run naked on the streets in shock (although, Archimedes did, well he was just crazy!)

3. Review who should be throwing "fraudulent regulators" out of business. I was a little beyond surprised to find out that the FDA was tasked with this. What about the justice department? After legalizing pot, crack, ganja, hashish, meth and moly, they do seem to have a lot of free time on their hands. Wouldn't preventing someone from doing research be something a bunch of lawyers did? Why is the FDA involved. Something is wrong here. I think even your golden retriever can see through this...

4. Do not simply pile stuff on the FDA and it's possible child organizations (if you take care of step 1, that is). It is not your once-a-week garbage truck. I cannot understand why the FTC couldn't take care of tobacco. Or maybe because it is not "food" and is directly related to "death and disease - in no particular order", why doesn't the CDC regulate this? Or maybe the HHS? I am not sure. But the FDA, to say this one more time, is not your "garbage truck".

5. More cash is not the answer. More cash means more taxes. More taxes mean more wastage. This is simply a case of divide and conquer.

6. With all the hope and change, I am sure we all got very teary eyed. Now, would be a great time to ground ourselves in reality. So, when people speak - LISTEN! If, in the course of discussions early this year, the Obama administration and/or Congress had paid any kind of attention to the clamor on splitting the FDA, all the world's Hernandezes and Campbells would now be out of a job.

Before we leave, here is some gobbledygook from the FDA as quoted by the NY Times Articles demonstrating unparalleled brain from body separation:

“The F.D.A. views any deviation from its high standards for developing or marketing drugs and devices as a potential threat to patient safety and public health,”


“We will take strong action against anyone who chooses to ignore or flout the legal requirements for the products we regulate.”

Especially with the last comment pasted right above, who else thinks that rolling some StarTrek credit music is in order?

"We will take strong action"

Exactly when?

Two Saturdays from never?

Watch your tax dollars rotting....

The NY Times Article:

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