Living Proof, Research Paper Example

Question one

The Process/Steps of FDA’s Drug Review

Phase Description
Pre-clinical phase


This is the first phase of drug review process of FDA. This is the stage where the manufacturing companies make continuous analysis and testing of various compounds to isolate the ones with therapeutic features. This phase normally takes about six years after which the manufacturer is expected to have completed the whole process of synthesis and purification processes after limited animal testing. If the company finds promising compounds, it goes ahead to file an IND (Investigational New Drug Application). This application is forwarded to FDA for approval by the FDA review committee with consists of sponsors, legal advisors and pharmaceutical experts. The committee keenly looks at what has been done with animals (preclinical results) and what is being proposed to be done with humans. Before approval, the committee also examines whether it is safe for the company to move ahead and carry out tests on humans. If approved, the manufacturer then proceeds to the first phase of drug development and review process (Bartley, 2010).


Clinical trials


Clinical trial begins only on condition that IND is approved by FDA and IRB (Local Institutional Review Board). The board consists of scientists as well as other experts from institutions of research as well as hospitals. The main duties of IRB are to approve the protocol of clinical trials through description of participants in the clinical trials, tests and procedures’ schedule, dosages and medications under study, objectives of the study among other details. The IRB also ensures acceptability of the study, ethical issues, and consent from participants and their awareness on risk involved. They also make sure that the researchers have put appropriate steps for protection of participants and patients (Hilts, 2003).


Phase 1


Healthy volunteers are the main participants in this phase for the studies carried out. The purpose is to find out the drug’s side effects that are frequent as well as metabolism and excretion of the drug. 30 to 90 participants may be used but the range varies (Bartley, 2010).
Phase 2


This phase commences on conditions that phase 1 exhibit no unacceptable toxicity. The main emphasis at this stage is on the effectiveness of the drug in terms of workability to people with certain disorders. Patients who receive this drug are compared with those under different approved treatment. However, there is still continuation of evaluation of safety and possible side effects on short term basis (Bartley, 2010).


Phase 3


Evidence of effectiveness of the drug induces the third phase. At this stage, the main duty is to gather as much evidence as possible concerning the safety and effectiveness of the drug for approval. Also, different populations and dosages are studied by use of the drug in combination with others (Hilts, 2003).



Questions two

Phase 4

The purpose of Med Watch in post marketing surveillance phase

The main purpose is to gather additional information about the drug concerning its safety, efficacy as well as its optimal use. In other words, it closely monitors how the drug is being used and the impact (Givel, 2005).

Question three

Drug Herceptin

Drug Herceptin is a cancer medication in form of monoclonal antibody with ability to suppress, slow down or interfere with the growth and spread of cancer cells. Metastatic breast or stomach cancers are the main disorders treated with this medication after failure by chemotherapy in most cases. The main route of administration is via vein injection to the blood system. One of the adverse reactions of Herceptin is that some patients have shown infusion reactions on receiving the injection. Such infusion reactions include dizziness, nausea, itchiness and running short of breath at the time of injection (Bazell, 2008).






Bartley, M. (2010) Free To Choose Medicine: How Faster Access to New Drugs Would Save Countless Lives and End Needless Suffering Chicago: The Heartland Institute.

Bazell, R. (2008). Her-2: the making of Herceptin, a revolutionary treatment for breast cancer. Random House.

Givel, M. (2005). Philip Morris’ FDA Gambit: Good for Public Health? Journal of Public  Health Policy (26): pp. 450–468.

Hilts, J. (2003). Protecting America’s Health: The FDA, Business, and One Hundred Years of  Regulation. New York: Alfred E. Knopf.