Administrative Law

All Signs Point Toward New Speed Limits on the Information Superhighway

November 11, 2013
Administrative Law, Internet

by Matt Mason, UMN Law Student, MJLST Staff

The net neutrality debate, potentially the greatest hot-button issue surrounding the Internet, may be coming to a (temporary) close. After years of failed attempts to pass net neutrality legislation, the D.C. Circuit will soon rule as to whether the FCC possesses the regulatory authority to impose a non-discrimination principle against large corporate ISP providers such as Verizon. Verizon, the plaintiff in the case, alleges that the FCC exceeded its regulatory authority by promulgating a non-discrimination net neutrality principle. In 2010, the FCC adopted a number of net neutrality provisions, including the non-discrimination principle, in order to prevent ISPs like Verizon from establishing “the equivalents of tollbooths, fast lanes, and dirt roads” on the Internet. Marvin Ammori, an Internet policy expert, believes that based on the court’s questions and statements at oral argument, the judges plan to rule in favor of Verizon. Such a ruling would effectively end net neutrality, and perhaps the Internet, as we know it.

The D.C. Circuit Court is not expected to rule until late this year or early next year. If the D.C. Circuit rules that the FCC does not have the regulatory power to enforce this non-discrimination principle, companies such as AT&T and Verizon will have to freedom to deliver sites and services in a faster and more reliable fashion than others for any reason at all. As Ammori puts it, web companies (especially start-ups) will now survive based on the deals they are able to make with companies like Verizon, as opposed to based on the “merits of their technology and design.”

This would be terrible news for almost everyone who uses and enjoys the Internet. The Internet would no longer be neutral, which could significantly hamper online expression and creativity. Additional costs would be imposed on companies seeking to reach users, which would likely result in increased costs for users. Companies that lack the ability to pay the higher fees would end up with lower levels of service and reliability. The Internet would be held hostage and controlled by only a handful of large companies.

How the FCC will respond to the likely court ruling rejecting its non-discrimination principle is uncertain. Additionally, wireless carries such as Sprint, have begun to consider the possibility of granting certain apps or service providers preferential treatment or access to customers. Wireless phone carriers resist the application of net neutrality rules to their networks, and appear poised to continue to do so despite the fact that network speeds are beginning to equal those on traditional broadband services.

In light of the FCC potentially not having the regulatory authority to institute net neutrality principles, and because of the number of failed attempts by Congress to pass net neutrality legislation, the question of what can be done to protect net neutrality has no easy answers. This uncertainty makes the D.C. Circuit’s decision even more critical. Perhaps the consumer, media, and web company outcry will be loud enough to create policy change following to likely elimination of the non-discrimination rule. Maybe Congress will respond by making the passage of net neutrality legislation a priority. Regardless of what happens, it appears as though we will soon see the installation of speed limits on the information superhighway.

Ready or Not, Here It Comes: The FDA’s Attempt to Regulate the E-Cigarette Industry

October 21, 2013
Administrative Law, Food and Drug Law

by Dylan Quinn, UMN Law Student, MJLST Staff

While the United States partial government shutdown created widespread uncertainty for federal employees and the monetary system, some are worried that the shutdown may cause the FDA to miss its self-imposed October 31, 2013 deadline for releasing the highly anticipated e-cigarette regulations. The FDA has already failed to meet its initial, self-imposed deadline of April 2013. While there are clearly no penalties for missing a self-imposed deadline, there are increasing external pressures that may force the FDA into action before the agency has a full grasp of the issues surrounding e-cigarettes.

It is estimated that e-cigarette sales in the U.S. will reach $1.7 Billion this year. E-cigarette use by students in middle and high school more than doubled from 2011 to 2012, according to the Centers for Disease Control and Prevention. They have become so popular that the use of the e-cigarette product has been coined, “vaping“.

While the FDA regulates e-cigarettes that are marketed for therapeutic purposes, it has made clear that it intends to treat e-cigarettes as a “tobacco product”, and establish regulatory control over the entire industry. However, by seemingly having this plan for years, the question arises of why the agency is on the brink of missing another deadline. The practical, and probable, answer is that the agency has no idea how to approach (or regulate) e-cigarettes.

Earlier this month the European Parliament took a “permissive approach” to e-cigarettes by shooting down proposals that called for strict regulation. European law makers seem to be influenced by the potential of e-cigarettes to be a healthy alternative to smoking, and are likely hesitant to place constraints on an industry that offers immense potential benefit to public health.

While the U.S. may benefit from taking the same approach, many think that the e-cigarettes are making nicotine addiction worse among youth, and there seems to be added pressure on the FDA to tightly regulate the industry. Just last month, Attorneys General from 41 states urged the FDA to issue the promised regulations, and there have been months of talks over a possible ban of online e-cigarette sales. However, the Obama Administration has just recently announced a significant funding program to operate 14 research centers focused on regulatory policy over tobacco products, and the FDA has expressly stated that more research is needed in regards to e-cigarettes.

There is no doubt that the public health impacts of e-cigarettes are not fully understood, and while this may not be a good enough reason to hold off strict regulation, the FDA may simply not know enough to effectively regulate the industry. Although continually missing deadlines, and gaining a better understanding, may lead to better regulation in the long run, the external pressures facing the FDA will not allow it to put off the regulations for much longer.

Is Food the New Tobacco: Science, Advertising, and the War Against Obesity?

April 18, 2013
Administrative Law, Agriculture, Food and Drug Law, Public Health

by George David Kidd, UMN Law Student, MJLST Staff

Globally, obesity and its underlying ailments have overtaken tobacco as the top preventable cause of death. But, while eating right and exercising might go a long way towards solving the problem, the solution might not be that simple. What drives consumer buying behavior, through more modern forms of how we interact with the world, might substantiate food science and advertising as powerful mechanisms to attack the obesity epidemic.

In Food Advertising and Childhood Obesity: A Call for Action for Proactive Solutions, published in Issue 12.2 of the Minnesota Journal of Law, Science & Technology, life and health sciences author Roseann Termini and others add advertising to the already-large list of “other” factors affecting childhood obesity rates. Indeed, children are not as informed as adults about health and may be more likely influenced by certain channels of advertising, such as television. To address this concern, one of her proposed solutions is to ban, regulate, or even shift tax structure in order to control advertising that specifically targets children. While this might be an effective mechanism to reduce demand, it may only be a partial solution. For one, because children are not, generally, the direct purchaser of food, but rather depend upon parents, to what extent does advertising actually affect the buying decisions of parents?

An article recently mentioned in The New York Times, The Extraordinary Science of Addictive Junk Food, might help answer this question. Mr. Moss similarly explores the “obesity epidemic,” but from a corporate standpoint, positing that consumers are primarily driven to buy what “tastes good.” While Mr. Moss’s article also agrees that advertising is part of the problem, he paints a more complete picture of what might be the underlying cause of parental acquiescence in a child’s poor dietary choices. The perfect combination of salt, fat, and sugar might be, in part, to blame as addicting foods that influence buying behavior. In this way, food is likened to tobacco, except, unfortunately, while people can choose whether to begin smoking, all people must eat.
While the analogy between food and tobacco may be imperfect, the point is there. If the majority of the food available to the everyday consumer is manufactured as addicting, to what degree is there a choice to eat healthy? If, in order to survive in the marketplace, a corporation has to manufacture “addicting” foods to compete, how can we make these addicting foods into disease-preventing rather than disease-aiding choices? Food science and advertising may contain the answer.

United States v. Caronia After-the-Fact: What Was All That Fuss About, Again?

April 9, 2013
Administrative Law, Food and Drug Law, Health Law

by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor

In a split decision on December 3, 2012, the Second Circuit issued its long-awaited opinion in U.S. v. Caronia–a case concerning off-label promotion and commercial free speech. The 2011 U.S. Supreme Court holding in Sorrell v. IMS Health acknowledging off-label promotion to be “per se” protected under the First Amendment marked a significant shift in this area of law. Previously, the Food and Drug Administration (FDA) was able to recover billions of dollars in penalties from manufacturers engaged in off-label promotion, or the act of promoting regulated products for uses other than those approved by the agency. Despite other challenges on constitutional grounds, the FDA has been successful at defending its current practice–that is, until recently.

After Sorrell, it was unclear how the Second Circuit would apply this precedent in Caronia. For a robust discussion of the holding in Sorrell and alternate regulatory pathways to mitigate the effects of constitutional challenges to FDA authority, see Rethinking Off-Label Regulation in the Wake of Sorrell v. IMS Health: Can State Involvement Compensate for Waning FDA Authority to Curb Commercial Free Speech? Much to the agency’s chagrin, the Second Circuit found that truthful, non-misleading off-label speech is in fact protected by the First Amendment and therefore cannot be prosecuted under the Federal Food, Drug and Cosmetics Act (FDCA). Although the circuit court opinion is not binding outside of its jurisdiction and is only one early example of how Sorrell will be interpreted by lower courts, the Caronia decision signals potentially diminishing regulatory authority in this realm.

To be sure, the gradual constitutional erosion of its authority to police purported FDCA violations is a viable cause for concern–but is it imminent? Though analysts predicted a more panicked response on behalf of the agency, the FDA has apparently decided not to petition the U.S. Supreme Court for certiorari, stating that the agency “does not believe. . . the Caronia decision will significantly affect [ its] enforcement” of off-label promotion. Because of its limited precedential value and the fact that both Sorrell and Caronia only recognize speech that is truthful and non-misleading as protected, the Second Circuit decision may have very little practical effect. In fact just last month in a related case out of the Ninth Circuit, U.S. v. Harkonen, the court chose to ignore Caronia altogether–asserting that the First Amendment does not protect “fraudulent speech.”

While off-label promotion itself cannot form the basis of an FDCA violation under Caronia, it may still be introduced as evidence of criminal misbranding. As such, it seems that the Caronia uproar could have all been for naught. The FDA’s reaction (or lack thereof) to the Second Circuit’s holding indicates that this is likely true. If nothing else, however, Caronia will surely increase the number of constitutional challenges to FDA enforcement activity, forcing the agency to reexamine its priorities. Thus, while Caronia has the potential for wide-ranging implications down the line, industry stakeholders will just have to wait and see. Although Caronia has done little to alter the regulatory landscape presently, it may only be a matter of time before a circuit split begins to evolve.

United States v. Caronia After-the-Fact: What Was All That Fuss About, Again?

April 9, 2013
Administrative Law, Food and Drug Law, Health Law

by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor

In a split decision on December 3, 2012, the Second Circuit issued its long-awaited opinion in U.S. v. Caronia–a case concerning off-label promotion and commercial free speech. The 2011 U.S. Supreme Court holding in Sorrell v. IMS Health acknowledging off-label promotion to be “per se” protected under the First Amendment marked a significant shift in this area of law. Previously, the Food and Drug Administration (FDA) was able to recover billions of dollars in penalties from manufacturers engaged in off-label promotion, or the act of promoting regulated products for uses other than those approved by the agency. Despite other challenges on constitutional grounds, the FDA has been successful at defending its current practice–that is, until recently.

After Sorrell, it was unclear how the Second Circuit would apply this precedent in Caronia. For a robust discussion of the holding in Sorrell and alternate regulatory pathways to mitigate the effects of constitutional challenges to FDA authority, see Rethinking Off-Label Regulation in the Wake of Sorrell v. IMS Health: Can State Involvement Compensate for Waning FDA Authority to Curb Commercial Free Speech? Much to the agency’s chagrin, the Second Circuit found that truthful, non-misleading off-label speech is in fact protected by the First Amendment and therefore cannot be prosecuted under the Federal Food, Drug and Cosmetics Act (FDCA). Although the circuit court opinion is not binding outside of its jurisdiction and is only one early example of how Sorrell will be interpreted by lower courts, the Caronia decision signals potentially diminishing regulatory authority in this realm.

To be sure, the gradual constitutional erosion of its authority to police purported FDCA violations is a viable cause for concern–but is it imminent? Though analysts predicted a more panicked response on behalf of the agency, the FDA has apparently decided not to petition the U.S. Supreme Court for certiorari, stating that the agency “does not believe. . . the Caronia decision will significantly affect [ its] enforcement” of off-label promotion. Because of its limited precedential value and the fact that both Sorrell and Caronia only recognize speech that is truthful and non-misleading as protected, the Second Circuit decision may have very little practical effect. In fact just last month in a related case out of the Ninth Circuit, U.S. v. Harkonen, the court chose to ignore Caronia altogether–asserting that the First Amendment does not protect “fraudulent speech.”

While off-label promotion itself cannot form the basis of an FDCA violation under Caronia, it may still be introduced as evidence of criminal misbranding. As such, it seems that the Caronia uproar could have all been for naught. The FDA’s reaction (or lack thereof) to the Second Circuit’s holding indicates that this is likely true. If nothing else, however, Caronia will surely increase the number of constitutional challenges to FDA enforcement activity, forcing the agency to reexamine its priorities. Thus, while Caronia has the potential for wide-ranging implications down the line, industry stakeholders will just have to wait and see. Although Caronia has done little to alter the regulatory landscape presently, it may only be a matter of time before a circuit split begins to evolve.

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