(Second in a Series of Pharmacy Articles)

In this paper I will give a very brief explanation how the process functions that must be gone through for a new drug to be approved for market use on patients. The process of starting a company and researching ways to treat disease is very specialized, long and complex. A pharmaceutical company must hire very highly trained scientists in chemistry and medicine to do research in developing a new drug. All kinds of detailed tests must be carried out and passed in every single phase of a multi-phase process. This type of research and testing takes years and is very expensive. The fact is that after all of this, to be more spelled out below, many new drugs fail to effectively enough do what they’re supposed to do or have an otherwise overly dangerous profile for Human consumption.

The idea of a drug is a chemical being introduced into a Human Being which is capable of either stimulating something that is needed to be operating or inhibiting something that isn’t without hurting the host (the person). If the drug kills or otherwise seriously hurts the host then the drug is not helping anything. A side effect of a drug is simply a way of saying that the drug has some activity that is in deed hurting the host but isn’t serious enough to counter the good of the drug.

From the sense of evolution it is interesting to note that all life on Earth has a common set of rules. All plants and animals have chemical reactions occurring to run their systems and these reactions are common to all life forms although there are some minor differences or variations here and there. For example, all living organisms must breathe in some way to obtain energy because all life forms must have energy to exist. It took billions of years for life to come into being and it doesn’t make sense to us that there would be two forms of it at the same time on the same planet. If a person who had pneumonia was given an antibiotic to kill the germs causing the pneumonia and that very same drug also killed to hosts cells then it could not be a drug that we could use. Killing the host is one way to kill the germs but the goal we’ve always gone by is to use a drug that selectively kills the germs and not the host’s.

So. In the U.S. it is the “FDA” (Food and Drug Administration) that regulates the new drug approval process. Phase 1 of that process involves building/creating a new drug and testing its physical properties to determine its optimum dosage and method of administration. Phase 2 preclinical research is done to test for toxicity of the drug usually on animals. Phase 3 involves the clinical trial on Humans in tightly controlled settings and Phase 4 is a continuation of Human trials on a much bigger scale. If the drug works well and has few side problems then it passes Phase 4 and the FDA has 6-10 months by law to approve it. Once approved it can be marketed. Phase 5 is After Market findings of the use of the drug. The fact is most drugs never get passed this stage. This always results in a devastating loss of time (10-20 years) and money (tens of millions of dollars) to the company that tried to get it done.

The FDA does have a Priority Review process to fast track drugs that may treat very serious conditions or treat conditions where there are no drugs available yet (Orphan Drugs and Breakthrough Drugs). Once on the market new drugs enjoy a 20 year patent protection where no other company can make a generic equivalent to compete which allows the inventors a fair chance to make back their research costs and profit off of the good work they did and the risk they took. But here, one can see, that without competition the price of the drug will be high. Part of the problem in addressing drug prices then is leaving protections in place to encourage others to take the steep risk to invent new and better drugs while keeping those drugs affordable.

Hopefully, after reading this piece you understand some of the arguments on the other aide of the drug pricing issue. It may well be that Congress is currently considering keeping the protections in place but exerting some legal control over pricing for the protections that they’re giving. Like in any monopoly situation, when the Government provides a monopoly by law it can also provide regulations on the monopoly by law. This will certainly address some of the prescription cost issues by stripping the right of the manufacturer to charge whatever it wants while at the same time enjoing a Government imposed monopoly in its favor.