How can we describe the essence of the process by which a pharmaceutical company and the Food and Drug Administration (FDA) function in the development of a new medication, showing understanding of conflicts of interest that sometimes occur?
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In a perfect world, the FDA would have no ties to anything except the facts. They would be a non-biased, totally objective organization.
In reality, no one is objective. The FDA is part of the Federal Government and so answers to politicians, political climate, and lobbyists. While they do incredible work keeping medication to a certain standard, they have also have terrible failures of judgement over the years. Admittedly, an objective organization would also make mistakes because its employees are human, but I can't help wondering how much of FDA policy has nothing to do with health and everything to do with government money.
The process seems to be more time consuming than free of bias. The laboratory is required to run tests on the new drug for around three years to determine general safety and efficacy before submitting the above mentioned reams of paperwork to the FDA. Once a submission is sent to the FDA, they examine the drug and its properties for a little over a decade. I believe the exact numbers are 3 years for the laboratory testing and 12 years for the FDA examination.
#5 is correct that the pharmaceutical companies themselves conduct the research that is submitted to the FDA to demonstrate the safety and efficacy of the drug under consideration. This is so obviously flawed that it's hard to believe the system was ever set up that way, but it is.
I have a friend who worked in the medical device development field, who told me that the FDA required so much paperwork that a typical submission to them required an entire UPS truck (and sometimes TWO of them!) devoted just to that shipment. Now, honestly, it is possible that that much paperwork is read carefully and is thoroughly understood before approval?
Let us remember that pharmaceutical companies are, at the end of the day, big businesses that are designed to make a profit. They do not have to take any Hippocratic Oath. This often means that there is tremendous pressure from managers to release medication without it being fully tested or that might have side effects. It is the FDA's job to regulate and approve medication to hopefully ensure that no harmful new medicines are released upon the unsuspecting public. We can clearly see how a conflict of interests could emerge due to the pressure that pharmaceutical companies would place on the FDA.
In addition to all of the above points, I have read that the testing that the FDA reviews is often testing conducted by the pharmaceutical company itself, not by an independent third party. Over the years, there have been many instances in which results were found to have been falsified. It would not solve every problem if we were to have a national service with the responsibility of conducting drug trials, since such a group could still be susceptible to influence, but it would be considerably more transparent than a for-profit company testing its own product. In science, results must be replicable, and at the very least, such a service could establish whether the claims of the pharmaceuticals would hold up in additional testing. Right now, it is clear that the foxes are guarding the hen house.
It is difficult to trust an organization that has been corrupted by large amounts of money in the political process to act solely for the benefit and protection of consumers. As pointed out above, drug industry ties conflict with the stated purpose of the agency, and in recent years, we have seen a long list of drugs that had been through the full FDA approval process and testing only to have some unforeseen complications and side effects. Clearly there are holes and flaws in the system that make the FDA less effective than it should be.
The conflict of interest is that the FDA is supposed to be regulating the drug companies but also has close ties to the industry. This is a very difficult situation for the FDA because it is simultaneously under pressure to approve drugs quickly (so as to help the industry make money) while at the same time ensuring that the drugs are 100% safe. These are goals that are generally in conflict with one another.
I think we need an agency like the Food and Drug Administration to protect consumers. Although it adds to the cost of drug development, it creates a safeguard for company's rushing through dangerous products. Even with those FDA regulations, there are still some drugs that turn out to be unsafe.
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