Annotated Bibliography

The Food and Drug Administration (FDA) in the United States is understaffed and underfunded, owing to a lack of adequate policies and management. One solution is to establish and enforce policies to ensure that the number of employees rises in tandem with the number of food workers and drugs entering the country. Thompson, C.A. (2012, August 15) New FDA law will help preserve the production of “life-saving” drugs. ASHP Pharmacy News. Retrieved August 31, 2012, FDA’s accomplishments are listed in this peer-reviewed paper. Despite the fact that the FDA is in desperate need of funds and personnel, it has made some progress in most ways, including avoiding opioid shortages. The organization worked with the government and signed the Food and Drug Administration Safety and Innovation Act. This legislation requires drug manufacturers to notify FDA about production interruption that may lead to a significant disruption in the supply of a drug in the country. I will use this source to show a positive effort FDA has made to regulate drug shortage despite the challenges it faces such as out-of-date technologies, under-funding, and under-staffing (Thompson, 2012).

Report of the Subcommittee on Science and Technology (2007, November). FDA Science and Mission at Risk. Retrieved February 20, 2013

This is a peer-reviewed journal that provides concrete findings on the way FDA is underperforming in certain categories because of under-funding and under-staffing, and it gives recommendations on how to improve their activities. This will assist in proofing the central points of how FDA is understaffed and under-funded, which then indicates a need for proper funding to safeguard the United States population. This source is credible since it is backed by many credible organizations like FDA Science Board (Report of the Subcommittee on Science and Technology, 2007).

Markel, H. (2005, November 16). Why America needs a strong FDA [Electronic version]. JAMA, 294(19), 2489-2491. Retrieved March 26, 2013,

This is a peer-reviewed article that describes the status of FIDA since it was established up to its current state, and how the institution needs to gain trust with people. I will add this information to my research for FDA to be boosted by the government to build on its inefficient areas such as technology, databases, staffing, and funding (Markel, 2005).

Denham, B.E. (2011, July 27). Dietary supplements–regulatory issues and implications for public health. JAMA. 306(4): 428-429. [Electronic copy] Retrieved August 22, 2011,

The source is a peer-reviewed article which addresses the case of regulation over dietary supplements with Dietary Supplement Health and Education Act (DSHEA). The acts mainly permit any dietary supplement to be placed on shelves for a consumer to buy without knowing if it will lead to minor or major side effects, allergic reactions or death since the supplement producers are not obliged to show proof of safety and efficacy of the products in FDA. I will link this regulation issue to how FDA should be more involved in increased staffing to make sure drugs are safe and make effective actions in preventing patients from being harmed (Denham, 2011).

Gupta, DK, and S-M Huang (2013, February). Drug Shortages in the United States: A Critical Evaluation of Root Causes and the Need for Action. Clinical Pharmacology and Therapeutics, 93(2), 133-135. Retrieved March 26, 2013

The source is also a peer-reviewed article that focuses on the issues that Food and Drug Administration Safety and Innovation Act (FDASIA) fail to address that results in significant drug shortages. I will use this article to counter FDA’s current government support, and show why FDASIA is not working and how they should seek government’s aid. The government should implement legislation that will increase funding for important organizations like FDA to boost their activities (Gupta and S-M Huang, 2013).

References

Denham, B.E. (2011, July 27). Dietary supplements–regulatory issues and implications for public health. JAMA. 306(4): 428-429. [Electronic copy] Retrieved August 22, 2011, from: http://jama.jamanetwork.com/article.aspx?articleid=1104131

Gupta, DK, and S-M Huang (2013, February). Drug Shortages in the United States: A Critical Evaluation of Root Causes and the Need for Action. Clinical Pharmacology and Therapeutics,93(2), 133-135. Retrieved March 26, 2013, from: http://www.nature.com.ezp2.lib.umn.edu/clpt/journal/v93/n2/pdf/clpt2012229a.pdf

Markel, H. (2005, November 16). Why America needs a strong FDA [Electronic version]. JAMA, 294(19), 2489-2491. Retrieved March 26, 2013, from: http://jama.jamanetwork.com.ezp2.lib.umn.edu/article.aspx?articleid=201856

Report of the Subcommittee on Science and Technology (2007, November). FDA Science and Mission at Risk. Retrieved February 20, 2013, from:http://www.chpa-info.org/media/resources/r_4840.pdf

Thompson, C.A. (2012, August 15) New FDA law will help preserve production of “life-saving” drugs. ASHP Pharmacy News. Retrieved August 31, 2012, from:http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=3760

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