Drug Legalization: Why It Is Harming American Citizens
For a drug to be approved by the United States Food and Drug Administration (FDA), it must undergo preclinical research, three phases of clinical studies, and ultimately New Drug Application (NDA) approval. Don A. Ballington, pharmacy technician training program coordinator at Midlands Technical College, collaborated with Robert J. Anderson, a pharmacist in both the hospital and retail settings, to create Pharmacy Practice for Technicians, a textbook used in the training of pharmacy technicians in preparation for pharmacy work. Pharmacy Practice informs readers of general pharmacy practices, as well as legislation concerning pharmacy work. In this textbook, Ballington explains the FDA Drug approval process in detail: Prior to the commencement of investigational research, an Investigational New Drug Application (INDA) must be submitted and approved by the FDA (Ballington 67). Only after INDA approval can investigational studies begin (Ballington 67). This research includes data about synthesis of active ingredients and fillers, as well as animal testing and a review from an institutional review board (Ballington 67). The first phase of investigational studies is composed of trials on a small number of healthy volunteers to learn about any side effects that come with the use of the drug (Ballington 67). Phase two involves a small group of patients with the targeted disease or condition that is intended for treatment in order to determine the effectiveness of said drug (Ballington 67). Phase two is heavily monitored by the FDA, and if both phase one and two “are promising,” phase three (phase two but with a larger patient pool) may commence (Ballington 67). Phase three is followed by the submission of a New Drug Application (NDA) to the FDA, and if approved, the drug may be marketed and is considered safe for public use. This process can take anywhere from five to fifteen years, making it difficult for drugs that could be an immediate help to be available for use. To help combat this, drug manufacturers can “fast-track” the drug approval, making the timeline drop from five years to 60 days. Although lawmakers meant well, this fast tracking has led to the premature approval of many drugs, causing an increase in drug-related accidents, such as overdose and death. In order for the US to properly treat its citizens in the sense of health care, the FDA must regulate brand name drug prices and to use people who will benefit the most from the potential benefits of the drug in phase two of the drug approval process.
The drug approval process, both the full and the streamlined versions, can cost millions of dollars for drug companies. These companies try to offset the cost of research and development by charging more from customers to use the brand name drug. According to Diane M. Porter, a journalist for The Pharmaceutical Industry, writes that prescription drug prices have skyrocketed in...