Essay Example on FDA Takes Action to Safeguard Public Health from Radiation Emitting Products

Introduction

The Food and Drug Administration (FDA) is a government agency that works in collaboration with other entities such as the Center for Food Safety and Applied Nutrition to safeguard public health from products that emit radiation. FDA assures the public through the provision of accurate and science-based health information on safety, efficacy, and security of drugs, medical devices, cosmetics, and biological products, among others. In pursuing the endeavor of keeping the public safe, FDA took a significant stride on November 22, 2013, and ordered genomics firm 23andMe from marketing Personal Genome Service ("Innovation, risk, and patient empowerment: The FDA-mandated withdrawal of 23andMe's personal genome service," n.d.). Linda Avey found 23andMe in partnership with CEO Anne Wojcicki as a direct-to-consumer genetic company. The company stated that its primary duty was to 'help persons and their doctors identify health areas that they needed to be keen on' (Dobbs, 2013). However, 23andMe was put on the spot by FDA and trended on the media all for the wrong reasons. Avey admits that the drift between the entity and government agency came as a shock as she admits, 'it surprised me' (Dobbs, 2013). 23andMe was at loggerhead with the FDA due to cultural shift or perhaps the failure of the current leadership not being keen on FDA directives. In the lens of the FDA, the agency argues that the spit kits used by 23andMe were not authentic DNA genotyping microassay. It perceives the tool as a medical device, but the firm uses a combination of the assay as a marketing gimmick to advertise what assay is all about. According to the FDA, 23andMe possesses numerous caveats they need to work on for them to be allowed to operate normally.

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Paraphrased passages

In his blog, David Dobbs highlights 23andMe's failure in complying with FDA protocols concerning the spit kit device. FDA, the public health watchdog, patiently engaged 23andMe for six months to consider the risk the firm was exposing its clients. As a result, the company was ordered to quit selling DNA test kits because they needed approval from the FDA. The agency affirmed that if 23andMe does not cooperate, it will take stern measures against the firm. FDA said it would take corrective action that might include, 'but are limited to, seizure, injunction, and civil money penalties' (Dobbs, 2013). 23andMe has previously sold spit kits where one can mail saliva to the company for analysis of data about the personal genome. The company is proud of its achievement as it claims that 'a simple DNA test led to an unexpected diagnosis for a mum and her daughter, changing their lives forever' (Dobbs, 2013).

Unfortunately, the plan of 23andMe was not aligned with the FDA's requirements. The goal conflicted with FDA since spit kit medical devices require regulation and close-fitting control of genetic data. In my view as a senior compliance officer, the FDA attempted to be accommodative. But as the agency's watchdog Matthew Harper states,' 23…is either …deliberately trying to force a battle with FDA, which I think would potentially win points for the moment the company represents but kill the company itself, or it is merely guilty of the single dumbest regulatory strategy I have seen in 13 years' of covering FDA (Dobbs, 2013). What 23andMe failed to realize is that they could not trifle with FDA and had no option but to fulfil with FDA demands.

Obedience is better than sacrifice, as demonstrated by 23andMe two years down the lane. After a struggle with the FDA, 23andMe established a novice framework for working with FDA. Instead of embracing a direct-to-consumer model that offered raw genetic data to clients without medical advice, the new device included carrier status test. The test determined genetic mutations that could be passed to children by their parents for 36 ailments and not 250 as earlier purported. Additionally, as Joshua Barajas depicts, the lift permitted 23andMe to market its ancestry reports based on personal DNA tests ("Innovation, risk, and patient empowerment: The FDA-mandated withdrawal of 23andMe's personal genome service," n.d.). The relaunch of the test kits allows individuals to determine the risk of transmitting some diseases such as sickle cell anemia. The impact of the test kits that now 'meet FDA standards for being clinically and scientifically valid' is positive since there is a drastic reduction in screening coverage, unlike there before.

Conclusion

Moreover, consumers are now able to pass their genetic information to drug manufacturing companies such as Pfizer that has assisted in the development of drugs. On the down-low, the price of the kit has gone up from $99 to $199 but does not deter customers from buying ("Innovation, risk, and patient empowerment: The FDA-mandated withdrawal of 23andMe's personal genome service," n.d.). FDA must be applauded for its commendable job of being the public eye in matters of public health. Reverberating the words of genomic researcher Mike, the Mad Biologist, FDA is comparable to a humongous tractor that is used to move space rockets slowly but crashes everything in its path for the well-being of its citizens

References

23andMe returns with modified, FDA-approved genetic tests. (2015, October 21). PBS NewsHour. https://www.pbs.org/newshour/health/23andme-returns-modified-fda-approved-genetic-tests

Dobbs, D. (2013, November 27). The F.D.A. vs. personal genetic testing. The New Yorker. https://www.newyorker.com/tech/annals-of-technology/the-f-d-a-vs-personal-genetic-testing

Innovation, risk, and patient empowerment: The FDA-mandated withdrawal of 23andMe's personal genome service. (n.d.). Semantic Scholar | AI-Powered Research Tool. https://www.semanticscholar.org/paper/Innovation%2C-risk%2C-and-patient-empowerment%3A-the-of-Downing-Ross/32a97efa3433e5c2af0ab5f61d16ba895a6bd5ba