The FDA is negotiating with the drug industry over a possible user fee increase which, if it goes through, would give the industry even more in setting the goals and priorities of its supposed regulator.
Industry user fees were first introduced in the early 1990s in an effort to help speed up the FDA's approval process; prior to that, the FDA had been funded entirely by Congress.
But steadily rising payments have led to drug makers funding more than half of the FDA's drug review process, giving them immense clout in determining how the agency is run.
Drug makes renegotiate the fees with the FDA every five years, meaning they can have a great deal of input regarding which programs will receive funding. Regulatory agencies do not normally need to negotiate their budget with the industries they oversee.
In 1993, $8.9 million of user-fee money accounted for 7 percent of the FDA's drug review budget. By 2004, the amount had risen to $232 million and 53 percent of the drug review budget.
One of the major reasons why I continually voice my concerns about the FDA's inability to protect you is their close financial ties to the drug industry.
Clearly user fees enacted in the 90s are allowing the drug industry to have major leverage over the FDA, and that control is continuing to increase. When the new changes take effect in fiscal 2007, if the FDA receives all it is seeking, the user fees will account for two-thirds or more of their drug review budget.
So please realize that the FDA, as currently configured, cannot adequately protect your health. What it can, and does, do is further the plans and profits of the multi-national drug companies.
Currently, within the Center for Drug Evaluation and Research, about 80 percent of the resources are geared towed the approval of drugs and a mere 20 percent is for everything else.
Drug safety is a measly 5 percent.
Can you possibly imagine that? Only a nickel out of every dollar is spent on determining if the drugs are actually safe to use!
This fact helps reveal their priorities -- priorities that the drug companies set every five years when the user fees are renegotiated. It is NOT about protecting you -- it is about approving drugs as quickly as possible so the drug companies can maximize their profits.
Drugs become less valuable to the companies when the patent runs out and cheaper, generic versions can be made. So companies lose $1 million to $2 million EVERY DAY a drug is held up from being marketed to you. So obviously, the incentive is to get drugs approved as quickly as possible, even if moving quickly is less safe. And these are priorities the companies pass on to the agency they fund.
The fox is guarding the henhouse. And it's going to stay like that until doctors, patients, and citizens start demanding changes to our current fatally flawed system of health care.