Article Writing Homework Help

Your assignment is to prepare and submit a paper on new pharmaceuticals (fda’s role in approving new drugs). New Pharmaceuticals and the FDAs Role in Drug Approval OF COLLEGE New pharmaceuticals are to strict vetting by the Food and Drug Administration (FDA), helping to prove that these new technologies are safe for human consumption and achieve what they set out to. This is all important in ensuring the safety of the patient-customer, as well as avoiding any set-backs that could harm the company and the shareholders, two factors that are very important in the pharmaceutical industry. One of the most important factors in the approval of a new drug is the clinical trial, a process in which the new drug is vigorously tested for side-effects on the target audience for the drug.

Clinical trials are the specialty of the FDA. Much like a car should not be bought without a test-drive, a drug should not be administered without testing under as many conditions as possible to ensure its safety (Office of the Commissioner, 2011). There are many different types of clinical trials, which include investigations into prevention options, new treatments (or new uses of old treaments), diagnosis options, and procedures that improve quality of life for existing patients (Couzin, 2004). The clinical trials are also conducted in stages to ensure the safety of those who get involved in the trials.

These phases of clinical trial are known as Phase I, Phase II, and Phase III. Phase I is the shortest and involves testing on a very small number of people to determine which dosage is most effective and how it interacts with the body. This can highlight any imperfections in the existing research. Phase II is essentially a large-scale study on the target population of patients, trying to discover if the drug is both safe and effective. Any side-effects will usually start to be noted here. Phase III is the final stage, and involves fine-tuning the drug for approval by the FDA. Information on dosages as well as double-blind controlled trials are usually conducted in this stage (Office of the Commissioner, 2011).

After conducting these trials, the information found will be submitted to the FDA for approval. The FDA will also usually have had some involvement in the earlier stages, as the dangers in clinical trials mean that they are often closely monitored (DerSimonian & Laird, 1986). At this stage, any approved drug enters what is known in the industry as Phase IV, which is indefinite. This means the drug can be marketed and dispensed to the population but that it will still be closely monitored by the FDA to ensure that there is complete safety. New scientific research and clinical trials can show that drugs that have been used widely can start to be considered dangerous by the scientific community and therefore all drugs are in this stage. For example, Vioxx is a drug that was famously approved by the FDA but continuous monitoring ensured that it was removed from the shelves as soon as any problems were noted (Couzin, 2004).

As evidenced above, this method is not always perfect as some drugs can slip through the net, either because of inaccurate clinical trials or long-term effects not noted in the existing clinical trials. Some can even become disapproved by the FDA based on new scientific research. The important part to note is that the FDA play a crucial and active role in the approval of new pharmaceutical products to ensure their safety and efficacy.

Works Cited

Couzin, J. (2004). Withdrawal of Vioxx Casts a Shadow Over COX-2 Inhibitors. Science, 306(5695), 384 -385. doi:10.1126/science.306.5695.384

DerSimonian, R., & Laird, N. (1986). Meta-analysis in clinical trials. Controlled Clinical Trials, 7(3), 177-188. doi:10.1016/0197-2456(86)90046-2

Office of the Commissioner. (n.d.). HIV and AIDS Activities – Basic Questions and Answers about Clinical Trials. WebContent, . Retrieved September 25, 2011, from http://www.fda.gov/ForConsumers/byAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm121345.