The short answer is that the U.S. Food and Drug Administration (FDA) works for the pharmaceutical companies, not the American people. Since 1992 a large portion of the FDA’s budget has come from drug companies instead of federal funding. The pharmaceutical industry finances the agency which regulates it. To make matters worse, the FDA does not conduct its own testing. Drug makers do the testing and the FDA relies on their reports of the results, which may or may not be honest and accurate.

 

For years the general public believed that FDA approval really meant something. That when they use a drug that is FDA approved they can rest assured that it will do what it is supposed to do and at the same time be safe. Conversely, lack of FDA approval was a black mark, and trying a medication that had not been approved was a risky endeavor, reserved for the desperate and dying.

 

That belief is changing. The FDA is quickly losing the trust and favor of the American people, as conflicts of interest and incompetence are revealed on many fronts. We question the safety of the food supply, having to wonder if the food we eat today may be recalled months or even years from now. Even more frightening, many patients wonder if the drugs their doctors say they must take to stay alive will be the very things that kill them.

 

Meanwhile, those with terminal illnesses are denied the experimental drugs which might save their lives, dying while they wait for FDA approval, yet willing to knowingly take the risk in exchange for a chance to survive.

 

When The Prescription Drug User Fee Act (PDUFA) was passed, in 1992, its purpose was to speed up the approval process. At that time AIDS patients were dying while they waited for new treatments to be approved. The FDA was short staffed and the approval process was abysmally slow.

 

There were protests and sit-ins. People were demanding action, but at the same time, the political climate called for a reduction in government spending. Something had to be done, and federal funding was not an option. So, like knights in shining armor, the pharmaceutical companies swept in with a plan. They would pay expensive fees to have their drugs reviewed, and in return the FDA would act under strict deadlines in the approval process. The PDUFA was born.

 

On the surface, offering to pay exorbitant fees may sound altruistic, but the pharmaceutical industry had much to gain. Getting drugs approved and on the market faster meant more profit. Paying the salaries of the very people who control whether or not a product goes to market at all was an obvious edge, and there was one more nasty card up its sleeve. In the original version of the PDUFA no portion of the fees could be used for safety monitoring after a drug was approved.

 

Every five years Congress must decide whether to keep the PDUFA. In September, 2007, it was renewed for the third time with amendments aimed at improving drug safety, including improved post-approval monitoring. Consumer safety advocates want to see the drug companies further removed from the approval process than the Act’s current incarnation requires.