Dow Corning Company Case Study Paper Example

For many years new products released by companies were always tested on animals. However, from the beginning of the 1980's a new alternative to safety tests did not require animals to reduce the rate of their death (Ziegler 180). Most animals that were used for testing was because of the cosmetic testing products such as anti-dandruff shampoos, anti-acne creams, sunscreens and toothpaste that contain fluoride because some of the ingredients used cause chemical changes that can be harmful to the human body. Therefore without the safety there is no assurance if the products are safe for human use.

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The alternative way in this case designed to reduce, refine and replace the use of animals and improve the accuracy of tests should be used before reaching the consumers. One good example is the use of alternative testing method because it uses the Vitro-cell cultures to find out whether the chemicals used in production will affect the human skin (Ziegler 187). The extent which any medical product should be considered safe before use is when they are evaluated on the validation of alternative methods by Interagency Coordinating Committee to ensure that the tests are accurately accredited safe for human consumption. The recommendations given on the alternative testing particularly for toxicology will be used as evidence by the federal agencies to update the testing guidelines and regulations (Stokes 80).

The research shows why the end use of any products is important. An excellent example of a product that is in high demand and that it should be tested first is the life-saving AIDS drug. In the early days of the AIDS epidemic, the HIV infection was considered a fatal disease that caused wreaked havoc since the 1980's (Levy 778). Today, the condition is no longer a killer disease because of the life-saving antiretroviral therapies because it has helped more than 21 million people to reduce the amount of the virus in their blood systems to undetectable levels.

This has made scientists have high ambitions by creating vaccines that formulate the long-acting treatments with the aim of finding a cure. This preventions strategy has had a significant impact to reduce the rate of reduction. For instance, in 2016, sexual health clinics in London discovered when the kit was used among the gay men that were infected with HIV dropped significantly as compared to statistics that were derived in 2015 (Levy 781). In San Francisco, the rate of HIV infections also reduced by 50 percent since 2006, because of the treatment plan approach is known as TasP (Levy 792). For products to be marketed in a different regulatory environment, efforts must be made to check how the drugs are performing in the market by identifying if there are any indications of early problems and how effective they can be addressed.

The FDA can regulate the effectiveness of the drugs in a rapidly changing context considering the laws that strengthen agency regulatory authority (Bain 20). Several rules, in this case, require the FDA to impose at the approval time that needs a limited distribution for a specific medical specialty within the required period to avoid contradictions. When such conditions are imposed, they vary because of the interpretations by occupants of the FDA's offices (Bain 29). This conditions will determine whether the product will be approved. However such conditions become difficult for the product to be approved for marketing as the efforts to facilitate such conditions depend on the voluntary compliance by the producer rather than the withdrawal threat of the drug in case it causes an imminent health hazard.

For any manufactured product to be marketed, it must acquire a regulatory authorization (New Drug Approval) and the Autorisation de Mise sur (Levy 795). Companies, in this case, will obtain a file relating to the AMM because it has the description of the active substance used by the manufacture and the nonclinical and clinical studies on the final product. The Dow Corning case is one example that that failed to use such procedures while they were pursuing to prove that the breast implants had silicon substances that were harmful to humans. Even after the mid-1970's evidence that silicones were biological inert, the company still chose to hide the evidence but began a new set of tests for health hazards.

Moreover, the Dow Corning company still did another research on the low-molecular-weight silicone and discovered that the immune system of mice was instead stimulated. While the company continued with the study, it failed to publish the results even after they were aware of the long-term data on health safety. The Dow Corning company in this case to avoid the conflicts it went through should have used the regulatory process to acquire valid license to prove their research. Even though the government did not have the mandate to approve any company relating research, the company would have managed to determine why the use of the human breast implants. Such evidence would have demonstrated that the application of the implants would have been declined.

Works Cited

Bain, Susan. "Introduction to FDA-Regulated Products." An Overview of FDA Regulated Products, 2018, pp. 19-41., doi:10.1016/b978-0-12-811155-0.00001-6.

Levy, Judith A. "AIDS and Injecting Drug Use in Later Life." Research on Aging, vol. 20, no. 6, 1998, pp. 776-797., doi:10.1177/0164027598206008.

Stokes, William. "The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)." Alternative Toxicological Methods, 2003, pp. 75-101., doi:10.1201/9780203008799.ch3.

Ziegler, Oliver. "Animal Testing for Cosmetic Products." EU Regulatory Decision Making and the Role of the United States, June 2012, pp. 177-210., doi:10.1007/978-3-658-00054-7_6.