Direct-To-Consumer Ads Are Misleading: Concise Statements of Effectiveness Should Be Required

The issue of required disclaimers in direct-to-consumer (DTC) advertising of pharmaceuticals boiled to the surface in May 2019, when the Centers for Medicare and Medicaid Services (CMS) published a final rule requiring the disclosure of a drug’s price in DTC ads. The idea is not a new one––the American Medical Association (AMA) adopted a resolution recommending just such a required disclosure in June 2017. For a number of reasons, even if the proposal is implemented it may not have much effect. Consumers may see price as an indicator of effectiveness, just as a high-priced car is expected to be superior to a lower-priced car, and insurance coverage may reduce patients’ concerns about a high-price for a drug. The significance of drug prices to consumers is further complicated both by the “market-distorting effects of third-party payors” and the requirement for consultation with and prescription by a licensed physician whose decisions may also be impacted by third-party payors, but is not necessarily affected by the list prices of drugs. However, the thesis of this article is not that disclosing prices in DTC ads is a bad idea, but that providing consumers with information about how effective advertised drugs are likely to be for them would provide information that patients need regardless of their insurance or financial status. Additionally, it would likely have a greater impact on the pharmaceutical marketplace. If the problem with DTC ads, as the AMA stated in its proposal to require price disclosures, is that “patients pressure physicians to prescribe certain medications that cost more than lower-cost alternatives and are not necessarily as efficacious,” then requiring DTC ads to provide consumers with clear information about the effectiveness of the advertised drug would be an even more powerful solution. There is a growing awareness of the need to require disclosures of expected effectiveness in pharmaceutical DTC marketing. Currently, consumers are told about the general condition for which a drug is used: e.g. “Drug X is approved for the treatment of major depressive disorder,” or “Drug X has been proven effective for the treatment of depression”; but rarely are consumers given information about the average benefit achieved in clinical trials or in post-market studies. This is a particular problem in DTC advertising for prescription pharmaceuticals. An article, in The New York Times by Elizabeth Rosen, highlighted the problem of DTC ads that are likely to mislead consumers about a drug’s effectiveness and provided this example: “Another ad promoted Jublia, a new topical drug for toenail fungus that costs thousands of dollars for a full course of treatment. Complete cure rates in studies—under 20 percent after 48 weeks of use—aren’t mentioned in the ads.” While the problem is becoming well known, as the New York Times article illustrates, the FDA regulation of pharmaceutical marketing is significantly constrained by the First Amendment’s protection of commercial speech, which would almost certainly make a ban on DTC pharmaceutical ads unconstitutional. This article provides an approach to FDA regulation of DTC ads that would address the problem within the limits of the First Amendment’s protection for commercial speech and provide patients with the information they need most to sort through the glossy promotional advertisements created by pharmaceutical companies and their ad agencies

Is the Prosecution of War Crimes Just and Effective? Rethinking the Lessons from Sociology and Psychology

Should perpetrators of genocide, violent acts against civilians during war, or other massive violations of core human rights be punished? International criminal law (ICL) answers this question affirmatively, asserting that the punishment of such atrocities is just and that their effective prosecution can (and should) contribute to the prevention of such future acts. Moreover, an increasing attempt has been made in the international and domestic arenas to act in accordance with these assertions of ICL through the prosecution of war crimes. During the last two decades the role of ICL has become gradually more significant, and the fall of the Soviet bloc has lifted the main political barriers that had prevented the implementation of ICL. Furthermore, the atrocities of the 1990s (mainly in the former Yugoslavia and Rwanda) have reaffirmed the post-World War II realization that means directed against states (such as reprisals and countermeasures) are insufficient to prevent those atrocities that ICL is designed to prevent and punish. These atrocities have also strengthened the moral conviction that perpetrators of such acts must be punished. Thus, ICL has been increasingly applied through the use of international tribunals that directly apply the norms of ICL, as well as through domestic prosecution of acts that constitute war crimes. These attempts on the international and domestic levels are strongly connected. Accordingly, it can be argued that an international penal legal system currently exists (ICL) and that the different international and domestic forums that partake in war crimes prosecution are simply different means that this system has to enforce its norms. Alternatively, it can be argued that each domestic enforcement mechanism should be viewed as a branch within the relevant domestic system, and thus the reference to ICL as a legal system should only be made in the context of war crimes prosecution made by international tribunals. This Article will not attempt to resolve this dispute and thus will use the dual terms ICL and war crimes prosecution. The Article intends to focus on attempting to justify a phenomenon that cannot be disputed: the considerable strength that direct and indirect enforcement of ICL norms through war crimes prosecution has gained in recent decades. The prosecution of war crimes is not without its critics. Much of the criticism of ICL and war crimes prosecution\u27s premises of just punishment and effective crime prevention is based on the findings of sociological and psychological research. As of yet, proponents of ICL and war crimes prosecution have failed to supply a sufficient response to this criticism. This Article attempts to fill this void

2021: Kelly Bohrer

During Women’s History Month, the Women’s Center coordinates, as an experiential learning opportunity for students, an annual exhibit highlighting the contributions women have made at the University of Dayton. The 2021 theme, Leading with Character and Resilience, captures what it means to work in the midst of a pandemic, social and political unrest and economic uncertainty. Each honoree displayed resilience, drive, character and tenacity and created inspiring ways to move forward.https://ecommons.udayton.edu/women_of_ud/1048/thumbnail.jp

Is the Prosecution of War Crimes Just and Effective? Rethinking the Lessons from Sociology and Psychology

Should perpetrators of genocide, violent acts against civilians during war, or other massive violations of core human rights be punished? International criminal law (ICL) answers this question affirmatively, asserting that the punishment of such atrocities is just and that their effective prosecution can (and should) contribute to the prevention of such future acts. Moreover, an increasing attempt has been made in the international and domestic arenas to act in accordance with these assertions of ICL through the prosecution of war crimes. During the last two decades the role of ICL has become gradually more significant, and the fall of the Soviet bloc has lifted the main political barriers that had prevented the implementation of ICL. Furthermore, the atrocities of the 1990s (mainly in the former Yugoslavia and Rwanda) have reaffirmed the post-World War II realization that means directed against states (such as reprisals and countermeasures) are insufficient to prevent those atrocities that ICL is designed to prevent and punish. These atrocities have also strengthened the moral conviction that perpetrators of such acts must be punished. Thus, ICL has been increasingly applied through the use of international tribunals that directly apply the norms of ICL, as well as through domestic prosecution of acts that constitute war crimes. These attempts on the international and domestic levels are strongly connected. Accordingly, it can be argued that an international penal legal system currently exists (ICL) and that the different international and domestic forums that partake in war crimes prosecution are simply different means that this system has to enforce its norms. Alternatively, it can be argued that each domestic enforcement mechanism should be viewed as a branch within the relevant domestic system, and thus the reference to ICL as a legal system should only be made in the context of war crimes prosecution made by international tribunals. This Article will not attempt to resolve this dispute and thus will use the dual terms ICL and war crimes prosecution. The Article intends to focus on attempting to justify a phenomenon that cannot be disputed: the considerable strength that direct and indirect enforcement of ICL norms through war crimes prosecution has gained in recent decades. The prosecution of war crimes is not without its critics. Much of the criticism of ICL and war crimes prosecution\u27s premises of just punishment and effective crime prevention is based on the findings of sociological and psychological research. As of yet, proponents of ICL and war crimes prosecution have failed to supply a sufficient response to this criticism. This Article attempts to fill this void