• Ruemon Bhattacharyya

The Complex World of Pharmaceuticals


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Today, pharmaceutical companies play a major role in the lives of millions of people in the United States. The healthcare industry has been ever-growing and with advances in technology it will continue to expand. The world of pharmaceutical creation is quite complex and has many different aspects that can be difficult to grasp. However, once understanding some of the key basics of the industry, it becomes more clear.  


So, what is a pharmaceutical exactly? A pharmaceutical is a chemical substance that is used to prevent, treat, or cure a disease. Today more than 10,000 prescription pharmaceutical drugs are available and they are part of a $260 billion dollar industry. In fact, the average American fills more than 12 prescriptions a year! Pharmaceuticals are divided into two categories, small molecule drugs and large molecule drugs. Most prescription drugs available are categorized as small molecules as they are less complex and chemically synthesized from natural products. On the other hand, large molecule drugs are far more complex and cost more money. 


Pharmaceutical companies invest large sums of money into research and development in order to ensure safety. There are also government regulations for developing a pharmaceutical drug. The Food and Drug Administration (FDA) is in charge of regulating and guaranteeing safety of goods that affect the health of the public. Safety is of the utmost importance to the FDA. In 2013 the FDA approved only 27 new drugs for use. 


The path to getting a FDA approval is quite lengthy. First, a pharmaceutical company will identify a promising molecular compound and testing begins on cells. If the cell testing proves successful, the company will proceed to animal testing. Once this is completed the company can submit a Investigational New Drug (IND) application to the FDA. Once the IND is approved, the company will move on to Phase I. Throughout Phase I the drug is tested on a small group of healthy volunteers (20-100) to learn more about absorption and excretion from the body. During Phase II the drug is tested on a larger group of volunteers who have the disease that the drug targets. Phase III, also known as randomized clinical trials, are usually double-blinded and multi-center trials with a large group of members that are targeted at patients with the disease of interest. Some of the patients receive the new drug while others receive a placebo. This phase is crucial in determining the efficacy of a drug and is often the most expensive and time consuming of the approval process. After the Phase III clinical trials, most pharmaceutical companies submit a New Drug Application (NDA) to the FDA. The NDA will contain all information known about the drug. The FDA has ten months to review the NDA and may either approve or disapprove the drug. If approved the company must collect reports of adverse drug interactions and submit them to the FDA periodically. 


New drugs are like any other invention, they are eligible to receive intellectual property protection from the United States. Intellectual property protection for pharmaceutical companies can be achieved in two ways. In a patent many aspects of the pharmaceutical can be patented such as molecular structure, method of use, and the manufacturing process. These patents last for 20 years, but most drugs are patented early in development, even before they are FDA approved. The second method of intellectual property protection is data exclusivity. Data exclusivity is the protection of drug clinical data given to the FDA for approval. 


New FDA approved pharmaceutical drugs represent years of research, development, clinical trials, and large sums of money. However, the painstakingly long process can provide years of pain free living for patients all around the world. As technology continues to advance, more and more innovative pharmaceutical companies will invent drugs that will cure and prevent the most debilitating of diseases, such as the coronavirus, in an effort to create a world with healthier, happier individuals. 




Sources:

https://www.lexology.com/library/detail.aspx?g=5fe621cd-4372-49af-933f-714b3e8e7a02

www.ismp.org/pressroom/viewpoints/CommunityPharmacy.pdf

www.contractpharma.com/issues/2013-07/view_features/top-20-pharma-report-/

www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM381803.pdf

www.gwu.edu/~iiep/governance/briefs/11FDA.pdf.  



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