Apparently, it has no role.  When the heparin was tainted, they had not inspected the plants that made the ingredients in China.  When the most recent batch of drugs were discovered to be ineffective, the FDA claimed that they did not determine effectiveness, but only safety.

Now, the FDA is on the verge of honestly filling its most recent role, that of protecting the pharmaceutical companies from lawsuits.

That brings us to the present situation… Johnson & Johnson’s Ortho Evra birth control patch.  It seems that the patch delivered more estrogen than had been determined to be safe, causing blood clots and strokes.  That information was according the internal documents at Johnson & Johnson.  Of course, they failed to mention that little tid bit to the FDA.  But, Johnson & Johnson is in business to make money, not make safe drugs.  And, even if they had told the FDA, what do we really think the agency would have done?  And, if you think the FDA has acted in the best interest of the public of late, I suggest you think again.

According to the NYT

…. because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.

It seems that Johnson & Johnson has close to 3000 lawsuits, all about this patch.  Some 40 to 50 deaths have been attributed to the patch.  The Ortho Evra patch was approved by the F-ing Drug Administration in 2001.  And, for the next four years the FDA got reports of the approximately 50 deaths.  And, they did nothing until November, 2005…. six years after Johnson & Johnson knew that too much estrogen was being released by the patches.

So, in defense of the FDA (please excuse me for offering a defense)

A series of independent assessments have concluded that the agency is poorly organized, scientifically deficient and short of money. In February, its commissioner, Andrew C. von Eschenbach, acknowledged that the agency faces a crisis and may not be “adequate to regulate the food and drugs of the 21st century.”

The F.D.A. does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly. Even when companies fail to follow agency rules, officials rarely seek to penalize them.

Okay, but please understand that the half-assed excuse is from the FDA, not me.

Personally, I prefer the more natural path for most of the medications I need.  You know, the herbs and vitamins and minerals.  Eastern medicine seems to be more effective with less side effects.  But, as one friend has told me time and time again, herbs are not FDA approved.  Exactly!  That’s why I go the natural route.  We can’t trust the FDA.

But, here’s the point.  The Supreme Court is going to allow the pharmaceutical companies to hide behind the FDA and continue to kill us en masse, one drug and one disease at a time, without fear of repercussion.  The FDA is totally ineffective and serves no purpose except to keep the taxpayers on the hook for government jobs.  With every incident that arises, the FDA has one reason or another why it didn’t do what it should have done or what a reasonable public would expect it to have done. 

So, let’s just stop the mental masturbation and disband, dissolve, or just do away with the agency.  It serves no purpose at this time.  It is totally ineffective and inefficient and obviously underfunded.  So, rather than continue to pretend that the FDA has a purpose, just admit that it is a black hole in Washington that sucks in taxpayer dollars and gives us nothing in return.  And, with the probable ruling from the Supreme Court, the FDA will protect the pharmaceutical companies to the detriment of the American people.