This almost qualifies as classic misdirection. Rather than properly change systems that seem far too difficult the Food and Drug Administration (FDA) has resorted to window dressing. The FDA advised that on 29 September 2006it issued final manufacturing quality systems guidance to the pharmaceutical industry. Essentially these are new recommendations that the FDA claims will modernize drug manufacturing.
So what hey? Why so much excitement over the fact that FDA has suggested ways the industry could modernize? Good questions. The FDA would like attention focussed on this matter right now. That’s one very good reason to stay sharp and look to see what untoward things they are really up to while attention is directed onto this issue. When dealing with the FDA a fair degree of suspicion, even a little paranoia, can be quite healthy.
The FDA wants us to believe that these much needed updates to manufacturing processes will reduce the cost of drugs to consumers. Maybe. Do you still believe in Santa too? A certain gullibility would help here. Most industries would jump at this opportunity to complain about the high costs of compliance and announce that the price of increased investment in modernization must be passed on to consumers through higher priced products.
The FDA said:
The Quality Systems Guidance is intended to provide manufacturers of pharmaceuticals with the ability to make technological improvements more readily, with appropriate regulatory oversight.
Commentts such as this are code in bureaucratic-speak. What it really says is that a way has been created that allows manufacturers to cut corners while still allowing the FDA to cover its back.
So what other issues could and perhaps should the FDA be addressing? Well, they could start with finding a better way to test drugs than just declaring them approved so they can watch the damage done. They watch, it seems, so they can ensure the longest possible market life for manufacturers. All the while they con people into believing that it is the consumers whom they protect. Only the most profoundly gullible (to put it kindly) could possibly believe the rhetoric from the FDA. But then, it appears that even a college education in the US does not by any means ensure any capacity for critical thought.
Perhaps they could even explore ways to solve the problem of the minimum 1.3 million injuries per year in the US caused by "medication errors." Of course that’s just the official figure. The true figure cannot be known but could be intelligently estimated at many times this figure.
One could go on all day with things the FDA could be doing. This won’t change what they are doing however. To see their issued guidance related to the use of good manufacturing practices following the new Quality Systems Guidance you can read the guidance in detail. The full text of the guidance can be found at: http://www.fda.gov/cder/guidance/7260fnl.htm.
However, I highly recommend that you take steps to ensure that you don’t require any pharmaceuticals. They are best avoided. Work on being so healthy there is little or no room for disease. If disease develops, find every way other than pharmaceuticals before even considering their use. If you do need drugs, take as little and as few as possible and find a physician who thinks like this, not one of the drug "friendly" majority.
