Reducing Unlawful Prescription Drug Promotion: Is the Public Health Being Served by an Enforcement Approach that Focuses on Punishment?

Despite the imposition of increasingly substantial fines and recently successful efforts to impose individual liability on corporate executives under the Park doctrine, punishing pharmaceutical companies and their executives for unlawful promotional activities has not been as successful in achieving compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) as the protection of the public health demands. Over the past decade, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) have shifted their focus from correction and compliance to a more punitive model when it comes to allegedly unlawful promotion of pharmaceuticals. The shift initially focused on imposing monetary penalties and was arguably justified by the expectation that financial punishment would achieve a level of compliance that would reduce the need for correction. By exacting enormous fines from companies, the agencies presumably hoped that the costs associated with unlawful promotion would be too high to justify the monetary benefits of non-compliance. Unfortunately, however, that approach has not been entirely successful. Despite the growth in settlements and penalties, and the recent efforts to hold individual executives liable for corporate misbehavior, the intended impact of substantially increased compliance has only partially materialized. The upward spiraling of settlement amounts and the trend toward prosecuting repeat offenders indicate that a change in approach is necessary. This article argues that FDA and DOJ cannot justify a continued emphasis on punishment without more demonstrable improvement in compliance and corporate accountability. The article goes on to describe several proposals to refocus the agencies’ efforts to effectively address the impact of unlawful promotion on public health by returning to an approach that emphasizes the more traditional goals of correction and compliance. It also argues that any meaningful protection of the public health ultimately requires a broader public understanding of the issues surrounding unlawful promotion of pharmaceutical products and greater participation by patients; physicians; health care professionals; and others with an interest in, and the opportunity to, impact this area. Increasing the public’s ability and interest in monitoring companies’ promotional activities at every level will reinforce the benefits of compliance, which will better serve the public health goals of the FD&C Act

Punishing Pharmaceutical Companies for Unlawful Promotion of Approved Drugs: Why the False Claims Act is the Wrong Rx

This article criticizes the shift in focus from correction and compliance to punishment of pharmaceutical companies allegedly violating the Food, Drug, & Cosmetic Act (FD&C Act) prohibitions on unlawful drug promotion. Traditionally, the Food and Drug Administration (FDA) has addressed unlawful promotional activities under the misbranding and new drug provisions of the FD&C Act. Recently though, the Justice Department (DOJ) has expanded the purview of the False Claims Act to include the same allegedly unlawful behavior on the theory that unlawful promotion “induces” physicians to prescribe drugs that result in the filing of false claims for reimbursement. Unchecked and unchallenged, the DOJ has negotiated criminal and civil settlements with individual pharmaceutical companies ranging from just under ten to hundreds of millions of dollars. In part, companies settle these cases to avoid the potential loss of revenue associated with the exclusion regime administered by the U.S. Department of Health and Human Services, under which companies risk losing the right to participate in federal health care programs. Even more disturbing, these settlements allow DOJ to circumvent judicial review of its enforcement approach, preventing any type of accountability for its legal theories or procedures. This article discusses the traditional enforcement methods employed by the FDA as well as the more recent DOJ prosecutions under the False Claims Act. Although it concludes that the FD&C Act should provide the sole means for prosecuting unlawful drug promotion, it also suggests that when prosecuting pharmaceutical companies under either Act, the government must avoid the temptation to mine companies for large settlements in lieu of developing a more coherent and responsible enforcement strategy

An Interprofessional Approach to Teaching Advocacy Skills: Lessons from an Academic Medical-Legal Partnership

Medical students and educators recognize that preparing the next generation of health leaders to address seemingly intractable problems like health disparities should include advocacy training. Opportunities to acquire the knowledge and skills needed to effectively advocate at the policy level to promote systems-, community-, and population-level solutions are a critical component of such training. But formal advocacy training programs that develop and measure such skills are scarce. Even less common are interprofessional advocacy training programs that include legal and policy experts to help medical students learn such skills. This 2016–2017 pilot study started with a legislative advocacy training program for preclinical medical students that was designed to prepare them to meet with Capitol Hill representatives about a health justice issue. The pilot assessed the impact of adding an interprofessional education (IPE) dimension to the program, which in this case involved engaging law faculty and students to help the medical students understand and navigate the federal legislative process and prepare for their meetings. Results from the pilot suggest that adding law and policy experts to advocacy-focused training programs can improve medical students’ advocacy knowledge and skills and increase their professional identity as advocates

The Academic Medical-Legal Partnership: Training the Next Generation of Health & Legal Professionals to Work Together to Advance Health Justice

As the national medical-legal partnership (MLP) movement grows, the need for doctors, nurses, social workers, other health professionals, and lawyers who have the knowledge, skills, and experience to collaborate effectively in this holistic healthcare approach is increasing. Given the unique role that institutions of higher education play in training students as they develop their professional identities, members of the Georgetown University Health Justice Alliance sought to build on prior efforts to define the MLP model by focusing on MLPs that exist in academic settings as a specific type of MLP. This report is based on the results of an environmental scan of MLPs that had evidence of engagement with a medical or law school and reflects the core elements of those MLPs as embodied by their objectives, activities, and unique features. The scan started with prior research conducted by the National Center for Medical-Legal Partnership, which categorized MLPs based on their targeted patient populations and identified eight core elements of infrastructure shared across MLPs. The Health Justice Alliance research team then collected data on the impact of interprofessional MLP learning on core undergraduate and graduate medical education knowledge, attitudes, and skill competencies sets for students. Other reports and articles describing specific MLP programs that create interprofessional education opportunities for law and medical students to learn and practice together also provided foundational background

The James Webb Space Telescope Mission

Twenty-six years ago a small committee report, building on earlier studies, expounded a compelling and poetic vision for the future of astronomy, calling for an infrared-optimized space telescope with an aperture of at least $4m$. With the support of their governments in the US, Europe, and Canada, 20,000 people realized that vision as the $6.5m$ James Webb Space Telescope. A generation of astronomers will celebrate their accomplishments for the life of the mission, potentially as long as 20 years, and beyond. This report and the scientific discoveries that follow are extended thank-you notes to the 20,000 team members. The telescope is working perfectly, with much better image quality than expected. In this and accompanying papers, we give a brief history, describe the observatory, outline its objectives and current observing program, and discuss the inventions and people who made it possible. We cite detailed reports on the design and the measured performance on orbit.Comment: Accepted by PASP for the special issue on The James Webb Space Telescope Overview, 29 pages, 4 figure

How medical-legal partnerships help address the social determinants of mental health

Conditions related to where you are born, live, learn, work, and age—the social determinants of health—account for more than half of overall health and well-being. Problems in these areas include food insecurity, unsafe and unaffordable housing, family violence and instability, employment discrimination, inadequate education, and lack of access to health insurance and care. Such problems negatively affect physical and mental health and contribute to the health disparities that disproportionately impact low-income and marginalized communities of color. Housing instability and homelessness, for example, can increase the risk of chronic illness, infectious disease, and death, and also have a profound impact on mental health, creating or exacerbating psychological distress, anxiety, and depression. Research indicates that even years after an eviction, mothers are more likely to be depressed and report feeling increased material hardship and parental stress. Many underlying social determinants of health implicate or raise legal issues that require advocacy to overcome. One patient might skip critical medical or psychiatric appointments because he is unaware of his legal rights in the workplace and is afraid of losing his job if he misses work. Another may suffer from severe depression even with significant counseling and medication management because of anxiety and stress associated with overwhelming debt or the threat of imminent family violence. Such “health-harming legal needs” create barriers to achieving good health and are major contributors to health disparities. Although nurses and other healthcare providers understand the significant impact social determinants have on health, they do not always draw connections between those determinants and the legal issues they raise. Nor do they generally think of law as a tool that can be prescribed to improve a patient\u27s health and well-being. Medical Legal Partnership (MLP) is an innovative healthcare model that fills that gap by bringing doctors, nurses, and other health professionals together with lawyers to address unmet legal needs that negatively impact health and well-being

How medical-legal partnerships help address the social determinants of mental health

Conditions related to where you are born, live, learn, work, and age—the social determinants of health—account for more than half of overall health and well-being. Problems in these areas include food insecurity, unsafe and unaffordable housing, family violence and instability, employment discrimination, inadequate education, and lack of access to health insurance and care. Such problems negatively affect physical and mental health and contribute to the health disparities that disproportionately impact low-income and marginalized communities of color. Housing instability and homelessness, for example, can increase the risk of chronic illness, infectious disease, and death, and also have a profound impact on mental health, creating or exacerbating psychological distress, anxiety, and depression. Research indicates that even years after an eviction, mothers are more likely to be depressed and report feeling increased material hardship and parental stress. Many underlying social determinants of health implicate or raise legal issues that require advocacy to overcome. One patient might skip critical medical or psychiatric appointments because he is unaware of his legal rights in the workplace and is afraid of losing his job if he misses work. Another may suffer from severe depression even with significant counseling and medication management because of anxiety and stress associated with overwhelming debt or the threat of imminent family violence. Such “health-harming legal needs” create barriers to achieving good health and are major contributors to health disparities. Although nurses and other healthcare providers understand the significant impact social determinants have on health, they do not always draw connections between those determinants and the legal issues they raise. Nor do they generally think of law as a tool that can be prescribed to improve a patient\u27s health and well-being. Medical Legal Partnership (MLP) is an innovative healthcare model that fills that gap by bringing doctors, nurses, and other health professionals together with lawyers to address unmet legal needs that negatively impact health and well-being

The Academic Medical-Legal Partnership: Training the Next Generation of Health & Legal Professionals to Work Together to Advance Health Justice

As the national medical-legal partnership (MLP) movement grows, the need for doctors, nurses, social workers, other health professionals, and lawyers who have the knowledge, skills, and experience to collaborate effectively in this holistic healthcare approach is increasing. Given the unique role that institutions of higher education play in training students as they develop their professional identities, members of the Georgetown University Health Justice Alliance sought to build on prior efforts to define the MLP model by focusing on MLPs that exist in academic settings as a specific type of MLP. This report is based on the results of an environmental scan of MLPs that had evidence of engagement with a medical or law school and reflects the core elements of those MLPs as embodied by their objectives, activities, and unique features. The scan started with prior research conducted by the National Center for Medical-Legal Partnership, which categorized MLPs based on their targeted patient populations and identified eight core elements of infrastructure shared across MLPs. The Health Justice Alliance research team then collected data on the impact of interprofessional MLP learning on core undergraduate and graduate medical education knowledge, attitudes, and skill competencies sets for students. Other reports and articles describing specific MLP programs that create interprofessional education opportunities for law and medical students to learn and practice together also provided foundational background

Co-creating a Legal Check-up in a School-based Health Center Serving Low-income Adolescents

The Problem: Marginalized populations experience health-harming legal needs—barriers to good health that require legal advocacy to overcome. Medical–legal partnerships (MLPs) embed lawyers into the healthcare team to resolve these issues, but identifying patients with health-harming legal needs is complex, and screening practices vary across MLPs. Purpose of Article: Academic and community partners who collaborate in an MLP at a school-based health center (SBHC) share their process of co-creating a two-stage legal check-up for adolescents. Key Points: Screening adolescents for health-harming legal needs is challenging. It took ongoing collaboration to refine the process to fit the needs of adolescents and meet the partners’ goals. Conclusion: Social determinants of health play a significant role in health disparities, and there is a need for innovative solutions to screen and address these in vulnerable populations. Other partners can learn from our experiences to co-create their own approach to addressing health-harming legal needs

Co-creating a Legal Check-up in a School-based Health Center Serving Low-income Adolescents

The Problem: Marginalized populations experience health-harming legal needs—barriers to good health that require legal advocacy to overcome. Medical–legal partnerships (MLPs) embed lawyers into the healthcare team to resolve these issues, but identifying patients with health-harming legal needs is complex, and screening practices vary across MLPs. Purpose of Article: Academic and community partners who collaborate in an MLP at a school-based health center (SBHC) share their process of co-creating a two-stage legal check-up for adolescents. Key Points: Screening adolescents for health-harming legal needs is challenging. It took ongoing collaboration to refine the process to fit the needs of adolescents and meet the partners’ goals. Conclusion: Social determinants of health play a significant role in health disparities, and there is a need for innovative solutions to screen and address these in vulnerable populations. Other partners can learn from our experiences to co-create their own approach to addressing health-harming legal needs