The Cost of Developing Your Medication

The Cost of Developing Your Medication

Health and Fitness October 18, 2016

Clinical study

In the United States, seven out of the top ten causes of death in 2010 were chronic diseases according to the Centers for Disease Control and Prevention. Three of the top ten chronic diseases are diabetes, cancer, and heart disease. With the increase in chronic diseases, pharmaceutical companies are developing new drugs every year to alleviate the symptoms or target the roots causes of illnesses.

Drug development is the process in which a new drug is taken through multiple stages after a possible compound has been found that can help someone struggling with an illness. The process involves two distinct phases: pre-clinical and clinical. Clinical drug development is covered here.

Clinical drug development involves clinical trials, where a drug that has been deemed safe through the testing on animals in the pre-clinical stage are then tried on humans. Although this may seem dangerous for the participants in clinical trials, regulations specify that the clients must give their consent.

A phase 1 clinical trial involves testing for safety and dosage. Many prescription drugs on the marketplace today contain a list of side effects, with some even having strong warnings about the danger of a particular drug towards integral body functions. The phase 1 clinical trial is designed to ascertain the appropriate dosage for safety purposes. This part of clinical stage involves healthy volunteers.

A phase 2 clinical trial focuses the testing on a small number of individuals with the disease. This is the initial reading of efficacy–how well a drug will combat the symptoms or root causes of an illness. Essentially, how effective it is. While this phase involves just a small number of individuals with the disease, it is an early marker on the effectiveness of the drug.

A phase 3 clinical trial is the most important trial in determining whether a drug will be approved by the Food and Drug Administration. Here is where medical research studies are conducted, using a high number of participants with the disease and adhering to statistical analysis to show if a drug is effective or ineffective. A clinical study here can make or break the clinical drug development process.

The general clinical drug development process can take years, according to the FDA, and not many make it through. According to statistics provided by the FDA, 70% move past the first stage. 33% of the remaining make it through the second and then 25-30% make it through the third.

While the cost of developing a new drug is complex because information is held confidential by pharmaceutical companies, released studies put the development cost per drug between the hundreds of million to over a billion dollars. However, some advocates for medical patients say that the cost of development can lead to high prices per prescription.