Regulating the Regulators: Suit Against the FDA Poses Question About Who Is Watching Those That Are Supposed to Be Looking Out For Us

Wade Coye

Wade Coye, Accident & Injury Attorney

Governmental regulation is something we encounter every day, pervading all aspects of life as American citizens; from the food we eat to the cars we drive, the way we communicate with one another, and even what we consider basic and fundamental rights of personal choice and liberty. Governmental regulation may be completely unconscious, but it persists to affect daily life regardless of our awareness of it.

In the news over the last year regarding the FDA’s regulatory responsibility over low grade antibiotic usage in livestock the reports have highlighted an escalating importance of public attention to overall governmental regulation, or lack thereof, and potential consequences on individuals and families. As a consumer, an attorney, and a father, the potential neglect in question brings up several key and interesting points of concern.

Briefly, the history of the issue is this: over the last 35 years (since 1977) the FDA has attempted to limit the use of antibiotics in agriculture, but efforts have been thwarted. The major opposition keeping this practice common has come from farming interests – meat agencies and their lobbying representatives in the industry. “Across the pond,” Denmark has led the European example since the 90’s; banning the use of antibiotics in all swine since 1999. In 2006 antibiotic usage was banned across the entire European Union for all livestock intended for human consumption. Still, the US failed to consider this example for public health even with outbreaks of disease such as the Avian flu (2003-2004) and swine flu (2009-2010).

Finally, last month the Natural Resource Defense Council, joined by the Center for Science in the Public Interest, the Food Animal Concerns Trust, Public Citizen, and the Union of Concerned Scientists, have collectively filed suit against the FDA for failing to meet its legal responsibility to protect public health. They are using medical and scientific research from the World Health Organization, the Centers for Disease Control and Prevention, The American Academy of Pediatrics, the USDA, and the National Academy of Science (amongst others) as evidence to support the basis for the suit. Allegedly, the research supports the public concern that bacteria becomes resistant to low-dose antibiotics while in the animals, and these resilient bacteria are passed to consumers. With bacteria increasingly resistant to the effects of medicines intended to eradicate them, consumers have a higher likeliness of becoming ill due to bacterial infection, and a lower chance of recovery from their illnesses because of a lack of medicine efficient to destroying the bacteria.

In upstate New York, my family have been dairy farmers providing for their local community and national distributors for four generations. Because of this personal history, I am familiar with the realities of government regulations, subsidies, and practices in the farming and food production industry. Farmers are and should be concerned about both about production of a quality product as well as their profit margin, whereas it seems at times that distributors, retailers, and government lobbyists are concerned only with the latter.

The agricultural industry is constantly changing and it is change which is necessary for progress. I have witnessed changes in the
industry during my own lifetime, such as stricter and more beneficial regulations against harmful pesticides such as DDT. Even less harmful pesticides were previously used more freely and are now under stricter regulations because of concerns for consumer protection and the public welfare. Unfortunately, the truth about the harmful effects of chemical compounds – even if they are not directly harmful to human consumption – can only be revealed after the fact. In the case of consistent presence of antibiotics in our food supply, if the effects are beginning to be recorded by the research findings of the prestigious agencies listed above, then it is absolutely time for the regulatory agencies with the power to affect the public well-being take action to have the effects for which they were created.

A more personal question about effects becomes that of individual and collective public retribution for these potentially negligent governmental actions. A highly publicized example of the last decade, Anderson vs PG&E – or more commonly known as the case of the Hollywood film Erin Brokovich –  was concerned with regulatory lapse in regulations of water contamination linked to health concerns. Only earlier this week, the US Supreme Court released a decision regarding an air quality suit. They stated that because a regulatory agency – in this instance the EPA – hasn’t yet acted to a public welfare concern does not mean that their authority is invalidated, and environmental concerns may not be matters to be settled judiciously if there is federal agency assigned to regulate the affair. The decision continued that states and private parties may petition the EPA for a rulemaking on regulations of specific pollutants, and the EPA’s response will be reviewed in federal court at that time. Interestingly, these three cases deal with the most precious and basic of human needs: air, water, and food.

Depending on the level of importance the media assigns to this suit against the FDA, the litigation could either become high profile and hotly debated publically, or could be decided completely under the public radar. Obviously, there are advocates who will attempt to promote and put the issue in the spotlight, and it is my belief that at least individuals should be educated in the potential effects on their lives and the lives of their children, even if they are not further concerned about the workings of government and regulatory agencies. Will individuals be allowed to bring individual or collective suit against the FDA or other agencies for a lack of protection in these circumstances? Only time will tell.

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