The evolving FDA -- The intended motivation of FDA’s establishment and its ramifications

When the subject of government’s appropriate role in food and drug industry was broached in the writing class, everyone thought the topic is very significant and worth discussing. On the one hand, the presence of government enforcement is necessary in the milieu of market failure. As an international student from China, a country replete with scandals about inferior products and toxic food, the public safety issues always haunt in my minds. After years of pondering and comparisons, Once I have come to the conclusion that market alone cannot solve all the problems, and an independent and authoritative institution like FDA in the United States seems very effective and essential when confronting with market failure and disorder. On the other hand, as a fiscal conservative, I am very aware of the danger of government expansion and bureaucratic redundancy, and the potential damage to free market generated by government intervention. My goal in this paper is to parse the historical intended function of FDA, and what are the ramifications due to the modern institutional expansion.

To achieve my goal, I have organized my paper into three sections. The first section tries to explore the historical context of the FDA establishment. Why was it established, and how was it functioned? The second section of this paper will emphasize the consequence of modern FDA expansion, and the unexpected ramifications sprung from the centralization of FDA and other regulatory agencies. The third section is reflection. I will discuss the new findings, and how will it change my mind.



HISTORICAL EVOLUTION

In February 1906, a sensational political novel The Jungle, written by journalist Upton Sinclair, reveals some horrifying inside stories about the revolting meat production process. For example, Sinclair describes vividly that “they would die, and then rats, bread, and meat would go into the hoppers together”. (Sinclair, 308) The new middle class in cities was shocked by his investigation, so did the incumbent president Theodore Roosevelt. The exportation of food industry declined significantly due to the publication, and a sense of distrust spread throughout the whole country.

“After The Jungle revealed that meat was often processed from diseased animals and tainted water, Congress worked with lightning speed to pass laws regulating the food industry”. (Dobie, 84) The Food and Drug Act was passed by the congress in response to the public furor, and the inspection responsibility was given to the USDA Bureau of Chemistry, which is the prototype of the FDA.

The 1938 Food, Drug, and Cosmetic Act signed by the president Franklin Roosevelt substantively expanded and clarified the power of the FDA, and FDA's “right to conduct factory inspections, and control of product advertising, among other items” was corroborated. The legislation actually was an immediate response to public anger due to the Elixir sulfanilamide tragedy in 1938. A chemist made sulfanilamide available to patients who were unable to take capsules, and the lethal combination of the sulfanilamide caused hundreds of casualties.

In 1968, the Electronic Product Radiation Control provisions were added to the Food, Drug, and Cosmetic Act, and the Drug Efficacy Study Implementation (DESI) was formed in that year. This expansion was a considerable structure reform which gives the FDA more power to tackle the public health and safety issues. The series of recombination and consolidation of FDA was ascribed to various scandals including the Thalidomide disaster in Europe and series publications written by environmental activists like Rachel Carson.

In the Nutrition Labeling and Education Act of 1990, the FDA was given the authority to require nutrition labeling of foods regulated by the Agency; and to require that all nutrient content claims and health claims meet FDA regulations.

In conclusion, the speed of expansion of FDA is gradual rather than precipitous. And every expansions of FDA were strongly connected to the special historical context and events.



CRITICISM & IMPLICATIONS

Initially, the regulatory role which the FDA played is very limited. Unlike nowadays, the emphasis of the legislation rested on the regulation of mislabeling rather than pre-market approval. And the primary concern of FDA is about safety rather than efficacy of drugs. During the past 100 years, the FDA is much respected given the alleged fact that millions of people are protected by the FDA from contaminated food and potential dangerous drugs which are detrimental to human body. However, nowadays, the FDA has evolved from a small government branch into a giant gorilla which possesses near 10, 000 employees with an annual budget of 2.5 billion. As a sub-agency of United States Department of Health and Human Services, the scale of the FDA is very striking.

The criticism of FDA grows gradually in tandem with the steps of FDA’s expansion. The most noted criticism comes from world renowned libertarian economist Milton Friedman, in the book Free to Choose: a Personal Statement, Friedman argues that the FDA should be abolished because it stifles innovation and competition, and the potential damage caused by FDA oppression is much greater than superficial benefits. He states that “considerable evidence has been accumulated that existing firms and existing drugs are protected from competition. New entry is discouraged, Research that is done will be concentrated on the least controversial, which means least innovative, of the new possibilities”. (Friedman, 209)

In an interview conducted by Hoover institute, Stanford University, Friedman refutes my early conclusion that a central agency like FDA is necessary when confronting with “market failure”, in Friedman’s opinion, the food safety can be guaranteed by free market, independent judiciary system and free speech. Because free market requires food safety as a prerequisite in order to compete with other rivalries given the fact that consumers don’t like contaminated food by nature. Moreover, an independent judiciary system makes class action suit available for consumer who suffers from poisoned food, and the high cost of class action suit settlement makes food factories less inclined to produce inferior products. Last but not least, free speech is the cornerstone of food safety because negative media exposure will definitely deter the bad behaviors.

Last but not least, the largest negative side-effect of centralization and consolidation of federal agencies like FDA is corruption. The latest episode of a popular drama in the United States, The Good Wife, sheds some light on the details of political corruption and professional lobbying. United States Department of Agriculture has the sway upon congress in the design of food guide, as a result, various interest groups, likes dairy and vegetable associations, have to hire lobbyists in order to influence the final decision of food guide adoption. This process makes the federal government become the hotbed of corruptions. A research paper published in 2002 on American Journal of Political Science found that FDA constantly approves some drugs faster than others, and the positive correlation between “the wealth of the richest organization representing the disease treated by the drug” and the speed of approval by the FDA is quite revealing.



REFLECTION

After this research, my opinion toward government regulatory agencies like FDA has changed significantly. The early conclusion that the presence of government enforcement is necessary in the milieu of market failure is unfounded. Every government existence and involvement in every domain in our life should be scrutinized, and the public should not take the government presence for granted, even it is democratic. The famous Austrian economist, Friedrich Hayek, has argued in his book The Road to Serfdom that “By giving the government unlimited powers, the most arbitrary rule can be made legal; and in this way a democracy may set up the most complete despotism imaginable”. (Hayek, 119)

The Economist once argues that there is a clear tendency that government is taking care of its citizens in every social domain and arbitrating what is the appropriate behavior. The magazine calls this tendency “soft paternalism”. Undoubtedly, this kind of new tendency is dangerous: “A new breed of paternalists is seeking to promote virtue and wisdom by default. Be wary”. The nutrition labeling ordered by the FDA is a perfect example of “soft paternalism”, because the government wants to influence what should we eat by concocting the right and appropriate labels silently.

One of the founding fathers of the United States, Benjamin Franklin, once incisively argues that “those who would give up essential liberty to purchase a little temporary safety deserve neither liberty nor safety”. Everyone should bear this sentence in mind.


Works Cited

"FDA History - Part I." U S Food and Drug Administration Home Page. U S Food and Drug Administration, 18 Aug. 2009. Web. 26 Nov. 2011. <http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm054819.htm>.

Friedman, Milton. "Uncommon Knowledge: TAKE IT TO THE LIMITS: Milton Friedman on Libertarianism." Hoover Institution. Stanford University, 20 Dec. 2010. Web. 26 Nov. 2011. <http://www.hoover.org/multimedia/uncommon-knowledge/26936>.

Friedman, Milton, and Rose D. Friedman. Free to Choose: a Personal Statement. San Diego: Harcourt Brace Jovanovich, 1990. Print.

Roberts-Dobie, Susan. "IowaPast Perfect: Out of "The Jungle"" NORTH AMERICAN REVIEW 292.3-4 (2008): 84. JSTOR. Web. 25 Nov. 2011.

Sinclair, Upton. The Jungle. Cambridge, MA: R. Bentley, 1971. Print.

"Soft Paternalism: The State Is Looking after You | The Economist." The Economist - World News, Politics, Economics, Business & Finance. The Economist Group, 6 Apr. 2006. Web. 26 Nov. 2011. <http://www.economist.com/node/6772346>.

Carpenter, Daniel P. "Groups, the Media, Agency Waiting Costs, and FDA Drug Approval."American Journal of Political Science 46 (2002): 490-505. JSTOR. Web. 25 Nov. 2011.

Jackson, Richard, and Benjamin Franklin. An Historical Review of the Constitution and Government of Pennsylvania [sic]. New York: Arno, 1972. Print.

Hayek, Friedrich A. Von., and Bruce Caldwell. The Road to Serfdom: Texts and Documents. London [u.a.: Univ. of Chicago [u.a., 2010. Print.