The proposed article provides an overview of European and North American states’ legislation, which regulates the procedure for pre-clinical research, clinical trials and state registration of medicinal products, as well as responsibility for its violation, analysis of the problems and prospects of adaptation of the national legislation to European legal space, particularly in the field of criminal and legal regulation of relations in the sphere of pre-clinical trials, clinical trials and state registration of medicine. The emphasis is put on (...) the matter that inclusion of Article 321-2 into the Criminal Code of Ukraine leads to a false concurrence with other provisions of the Code. The author proposes to introduce recent EU legislation (Acquis Communautaire) on legal regulation of clinical trials and circulation of medicine into the law of Ukraine, clarify terminology related to Fundamentals of Ukrainian Legislation on Health Protection and the Special Part of criminal law, introduce criminal liability for legal entities that will provide effective control over negative effects of research centers’ activity. It is suggested to develop legislative proposals to improve the provisions of the Criminal Code of Ukraine, which provide legal protection of relations arising in connection with pre-clinical research, clinical trials and state registration of medicinal products. (shrink)

This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory structure that has (...) developed since the 1960s. In general product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility a product is harmful, whereas establishing liability in litigation requires proving that the product was actually harmful.As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control. (shrink)

One of the most important and challenging issues of business ethics—or indeed of ethics more generally—is that of “moralresponsibility.” And though this problem has been with us from the outset of reflection on ethics and business, the followingdevelopments in the late twentieth century have exacerbated its difficulty: the increased mobility among people, the development of increasingly complex technologies with ever more significant consequences, the extension of the distance between people’s actions and the effects of their actions, the extended distance between (...) the manufacturers of products and the consequences of those products, the expanded possibilities for anonymous actions, and the collapse of many customary forms of restraints between both individuals and organizations. As a consequence, I believe, we are in the midst of rethinking and developing new and creative ways of extending our notion of responsibility. (shrink)

One of the most important and challenging issues of business ethics—or indeed of ethics more generally—is that of “moralresponsibility.” And though this problem has been with us from the outset of reflection on ethics and business, the followingdevelopments in the late twentieth century have exacerbated its difficulty: the increased mobility among people, the development of increasingly complex technologies with ever more significant consequences, the extension of the distance between people’s actions and the effects of their actions, the extended distance between (...) the manufacturers of products and the consequences of those products, the expanded possibilities for anonymous actions, and the collapse of many customary forms of restraints between both individuals and organizations. As a consequence, I believe, we are in the midst of rethinking and developing new and creative ways of extending our notion of responsibility. (shrink)

In this paper I examine the most common objection to strict product liability: that it is unfair to manufacturers. Critics have maintained that it is unfair because it allows manufacturers to be held liable even when they have not been negligent, and are not morally blameworthy or at fault. In response to this objection, I argue 1) that there are in fact cases in which it is at least somewhat unfair to manufacturers to impose compensation requirements upon them in (...) accordance with the strict product liability doctrine, but 2) that there is also a class of cases in which it is fair to manufacturers to hold them responsible for compensating injured product users, as strict product liability requires, even though they have not been negligent and are not morally blameworthy or at fault. My analysis of the fairness issue provides a basis for some concluding remarks about the defensibility of the strict product liability doctrine. (shrink)

On April 7,2000 a Florida jury ordered the tobacco industry to pay $12.7 million in compensatory damages to three former smokers who were chosen to represent hundreds of thousands of Florida residents in an unprecedented class action lawsuit. The decision not only marks the first time that a jury has found on behalf of smokers in a class action lawsuit, it also sets the stage for a huge punitive damage award against the industry. The awards followed a finding by the (...) same jury last July that the cigarette manufacturers have “acted with reckless disregard” and “engaged in extreme and outrageous conduct” while conspiring to mislead the public about the health risks of smoking. These previous findings make it likely that there will be punitive damages levied against the tobacco companies when the jury reconvenes in May. (shrink)

On April 7,2000 a Florida jury ordered the tobacco industry to pay $12.7 million in compensatory damages to three former smokers who were chosen to represent hundreds of thousands of Florida residents in an unprecedented class action lawsuit. The decision not only marks the first time that a jury has found on behalf of smokers in a class action lawsuit, it also sets the stage for a huge punitive damage award against the industry. The awards followed a finding by the (...) same jury last July that the cigarette manufacturers have “acted with reckless disregard” and “engaged in extreme and outrageous conduct” while conspiring to mislead the public about the health risks of smoking. These previous findings make it likely that there will be punitive damages levied against the tobacco companies when the jury reconvenes in May. (shrink)

It has been suggested that a new form of moral responsibility, labeled “social products liability,” is relevant to business ethics.In particular, this kind of responsibility might justify recent legal claims against firearm manufacturers. This paper argues that, as ithas been presented, social products liability must rest upon utilitarian considerations or on a deeper, more complete theory of moralresponsibility. In the first case, a new form of responsibility seems unnecessary, since liability could be directly apportioned on (...) utilitariangrounds. In the second case, proponents of social products liability face the tasks of presenting the more complete theory and then anchoring social products liability to it. (shrink)

This essay proposes a way of dealing with the strict liability of Internet sellers of other manufacturers’ products, such as Amazon under its ‘Fulfillment by Amazon’ program. I discuss and reject two approaches to the problem that have been proposed by the courts, and advance a view according to which the relevant inquiry is whether Internet intermediaries such as Amazon could have prevented a defective product from reaching the US market. This view accounts in a satisfactory manner for (...) the notion of responsibility that is at the core of US strict products liability law, and avoids the pitfalls of alternative policies. However, since this view also entails a de facto quasi-immunity to lawsuits for Internet intermediaries in many cases, safeguards to that quasi-immunity are also addressed. While the essay focuses on US law, the principles and policies under discussion should be applicable in other jurisdictions as well. (shrink)

In recent years, a number of prominent scholars have touted the use of litigation as an effective tool for making public health policy. For example, Stephen Teret and Michael Jacobs have asserted that product liability claims against car makers have played a significant role in reducing automobile-related injuries, Peter Jacobson and Kenneth Warner have argued that litigation against cigarette manufacturers has advanced the cause of tobacco control, and Phil Cook and Jens Ludwig have suggested that lawsuits against the firearms (...) industry can reduce gun violence. Critics have attacked this use of litigation as doing more harm than good to public health and as a misuse of the courts. This debate involves two distinct controversies: one over whether the public health benefits of litigation outweigh its costs and the other over the proper role of courts within our system of government. (shrink)

In recent years, a number of prominent scholars have touted the use of litigation as an effective tool for making public health policy. For example, Stephen Teret and Michael Jacobs have asserted that product liability claims against car makers have played a significant role in reducing automobile-related injuries, Peter Jacobson and Kenneth Warner have argued that litigation against cigarette manufacturers has advanced the cause of tobacco control, and Phil Cook and Jens Ludwig have suggested that lawsuits against the firearms (...) industry can reduce gun violence. Critics have attacked this use of litigation as doing more harm than good to public health and as a misuse of the courts. This debate involves two distinct controversies: one over whether the public health benefits of litigation outweigh its costs and the other over the proper role of courts within our system of government. (shrink)

This paper postulates that the proper function of tort law is to provide protection from, and redress of, non-consensual invasions of individual rights of person and property. It then proceeds to analyze and criticize, in that context, several theories of the law of unintentional torts including traditional English negligence law and the models of Posner, Fletcher and Epstein. That analysis proceeds in terms of the answers of each theory to a uniform set of questions which must be answered by any (...) theory of the law of unintentional harms. The paper concludes that none of the theories examined is rights-based or, indeed, consistent with the existence of individual rights of person and property.The paper goes on to elucidate a theory of liability which is rights-based. That theory turns out to be variant of traditional English negligence law in which reasonable foreseeability of harm to legally recognized rights or interests is the sole criterion of liability, the burden of precautions on the agent of the harm being explicitly excluded from consideration. (shrink)

Fully updated and revised, this contemporary classic discusses the powerful moral issues facing corporate America: conflicts of interest, payoffs, trade secrets, insider trading, product safety and product liability, hiring, drug testing, sexual harassment, diversity, reverse discrimination, employee productivity monitoring, Internet/computer privacy, worker safety, whistle-blowing, ethical decision-making, ethical accounting and advertising practices, environmental responsibility, down-sizing, and the conduct of multinational corporations. These are just some of the many topics raised in this versatile text. Enhanced by many new case studies, questions (...) for discussion, and valuable bibliographies, Business Ethics focuses on the issues that will confront decision-makers well into the new century. (shrink)

Science fiction is fast becoming reality as scientists and engineers seek to develop new ways of directly accessing and controlling our brains through brain-computer and even brain-to-brain interfaces. If such research is to receive continuing public approval and support—and not invite opposition—it must anticipate the special ethical challenges it creates. By pointing to some of the acute concerns raised by neural engineering technologies—around issues of identity, normality, authority, responsibility, privacy, and justice—Eran Klein and colleagues model and stimulate the kind of (...) reflection that will be needed as new brain technologies are developed. And yet, as I read their informative discussion, I find myself asking even more questions. One concerns the ethical novelty of these technologies. For example, in terms of questions of identity, normality, responsibility, and authority, how different is deep brain stimulation from the potent psychiatric drugs that have been administered for decades? How different in terms of issues of liability associated with malfunction or misuse are brain-computer interfaces from other complex devices now routinely in use? Neither ethics nor law will have to rethink things from scratch as new neural devices and capabilities are introduced: the groundwork for answering some of these questions has already been laid in a variety of fields from bioethics, to health and product liability law. Nevertheless, I conclude that there are new questions here. It is not simply the fact that neural technologies pose questions of identity, privacy, and the like but that they do so with a degree of intensity that creates qualitatively new challenges. (shrink)

In this article I attempt to examine the justification for the mandatory drug testing of employees. The justification commonly assumes the form of the productivity argument which states that an employer has a proprietary right to regulate the purchased time of the employee. Since the employer may be rightfully concerned with the employee''s productive output, so this argument goes, the employer retains the right to motivate production. By extension, the employee''s behavior outside of the workplace which affects his or her (...) productive capacity may also be regulated, including drug use which may affect this capacity. Thus it is claimed that the employer has the right to test employees for drug use and to impose sanctions when it is discovered.I argue that the implications of the productivity argument lead to unacceptable consequences and thus must be rejected. The productivity argument can be examined in light of a thought-experiment in which the reader is asked to imagine the discovery of two drugs, both of which enhance employee productivity. Calling these drugs hedonine and pononine, I imagine the first to be pleasurable to the employee while the second is accompanied by a degree of pain and discomfort. Since the mandated use of both of these imagined drugs would be consistent with the productivity argument, I maintain that the productivity argument thereby fails and so must be rejected. As employee drug testing is justified by this argument, it must also be rejected. (shrink)

The Vioxx drug recall and other cases of withdrawals of approved pharmaceutical products as a result of reports of serious harm to users indicate that there are many problems associated with the process of getting these products to the end user the ordinary person in the street. The problems include those related to drug/medical device research and development, clinical trials, presentation and publication of research results, approval by regulatory authorities, preparation of clinical practice guidelines, marketing of products (...) by commercial companies and post-marketing surveillance. This article discusses threats to the integrity of each of these processes and argues that the steady stream of drug recalls indicates the existence of a systemic problem. It concludes with a discussion of possible solutions to these problems. (shrink)

This paper examines some of the possible legal implications of the production, marketing and use of expert systems. The relevance of a legally useful definition of expert systems, comprising systems designed for use both by laymen and professionals, is related to the distinctions inherent in the legal doctrine underlying provision of goods and provision of services. The liability of the sellers and users of, and contributors to, expert systems are examined in terms of professional malpractice as well as product (...) liability. A recurring theme indicates that legislators may be inclined to restrict possibilities of liability suits in order to avoid disincentives to the creation of expert systems. (shrink)

BackgroundThe U.S. Food and Drug Administration traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, (...) we convened a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation. (shrink)

This paper discusses the economic, legal, moral, and political difficulties in developing drugs for the developing world. It argues that large, global pharmaceutical companies have social responsibilities to the developing world, and that they may exercise these responsibilities by investing in research and development related to diseases that affect developing nations, offering discounts on drug prices, and initiating drug giveaways. However, these social responsibilities are not absolute requirements and may be balanced against other obligations and commitments in light of (...) economic, social, legal, political, and other conditions. How a company decides to exercise its social responsibilities to the developing world depends on the prospects for a reasonable profit and the prospects for a productive business environment. Developing nations can either help or hinder the pharmaceutical industry’s efforts to exercise social responsibility through various policies and practices. To insure that companies can make a reasonable profit, developing nations should honor pharmaceutical product patents and adhere to international intellectual property treaties, such as the Trade‐Related Aspects of Intellectual Property Rights agreement. To insure the companies have a good business environment, developing nations should try to promote the rule of law, ethical business practices, stable currencies, reliable banking systems, free and open markets, democracy, and other conditions conducive to business. Overall, this paper advocates for reciprocity and cooperation between pharmaceutical companies and developing nations to address the problem of developing drugs for the developing world. In pursuing this cooperative approach, developing nations may use a variety of other techniques to encourage pharmaceutical companies to act responsibly, such as subsidizing pharmaceutical research, helping to design and implement research protocols, providing a guaranteed market, and bulk buying. (shrink)

Corporations, through their products and behaviors, exert a strong effect on the well-being of populations. Industries including frearms, motor vehicles, tobacco, and alcohol produce and market products negatively impact public health. All of these industries are composed of corporations, which are legal fctions designed to provide limited exposure to liability, through a variety of mechanisms, for their investors and directors. This means that when actions are taken on behalf of a corporate entity, the individuals responsible generally will (...) not face personal liability for the negative results of those actions. To illustrate this point, this article considers corporate products or practices that have caused harm in varied settings, and analyzes the role that limited liability played in these cases. In addition, the article identifes ways to modify or eliminate some of the principles and practices that accompany limited liability. (shrink)

ABSTRACT This paper reviews the dynamics behind, and ethical issues associated with, the phenomenon of drug resistance. Drug resistance is an important ethical issue partly because of the severe consequences likely to result from the increase in drug resistant pathogens if more is not done to control them. Drug resistance is also an ethical issue because, rather than being a mere quirk of nature, the problem is largely a product of drug distribution. Drug resistance results from the over‐consumption of antibiotics (...) by the wealthy; and it, ironically, results from the under‐consumption of antibiotics, usually by the poor or otherwise marginalized. In both kinds of cases the phenomenon of drug resistance illustrates why health (care) – at least in the context of infectious disease – should be treated as a (global) public good. The point is that drug resistance involves ‘externalities’ affecting third parties. When one patient develops a resistant strain of disease because of her over‐ or under‐consumption of medication, this more dangerous malady poses increased risk to others. The propriety of free‐market distribution of goods subject to externalities is famously dubious – given that the ‘efficiency’ rationale behind markets assumes an absence of externalities. Market failure in the context of drug resistance is partly revealed by the fact that no new classes of antibiotics have been developed since 1970. I conclude by arguing that the case of drug resistance reveals additional reasons – to those traditionally appealed to by bioethicists – for treating health care as something special when making policy decisions about its distribution. (shrink)

Corporations, through their products and behaviors, exert a strong effect on the wellbeing of populations. Public health practitioners and academics have long recognized the harms associated with some corporations’ products. For example, firearms are associated with approximately 30,000 deaths in the United States each year1 and over 200,000 deaths globally. Motor vehicles are associated with about 40,000 deaths in the United States each year and over 1.2 million deaths globally. Tobacco products kill about 438,000 people each year (...) in the United States5 and about 4.9 million people worldwide. In addition to producing unsafe or harmful products, some corporations behave in ways that negatively impact the public’s health, such as marketing alcohol to youth and other vulnerable populations. Given these observations, one can conclude that it is possible to quantify the public health impact of individual industries, such as firearms, motor vehicles, tobacco, and alcohol. Health professionals can then target these individual industries to prevent or lessen the harms they cause. (shrink)

Illegal drugs are not inherently unclean, any more than alcohol, tobacco, or canola oil. All of these are simply chemicals that people choose to ingest for enjoyment, and that can harm our health if used to excess. Most of the sordid associations we have with illegal drugs are actually the product of the drug laws: it is because of the laws that drugs are sold on the black market, that Latin American crime bosses are made rich, that (...) government officials are corrupted, and that drug users rob others to buy drugs. (shrink)

ABSTRACTIn April of 2000, Diana Levine went to a clinic in Vermont suffering from a migraine headache. She was given the drug Demerol for the migraine symptoms and Phenergan for nausea. Complications with the administration of Phenergan ultimately resulted in Ms. Levine contracting gangrene, necessitating the amputation of her right arm. Ms. Levine sued the drug maker, Wyeth Pharmaceutical, in state court and prevailed. The lower court's decision was appealed by Wyeth to the state supreme court where the ruling was (...) confirmed. Wyeth next appealed to the U.S. Supreme Court which, to the surprise of many observers, affirmed the judgment of the state supreme court. At issue was the fundamental question of the ability of consumers to obtain redress against negligent manufacturers in state courts. Wyeth's arguments to the Court were based upon preemption: Foodand Drug Administration approval of a drug preempts the ability of injured consumers like Ms. Levine to recover in state courts despite years of precedent to the contrary. Ability to recover damages in state courts represents, perhaps, the most important safety net available to consumers injured by defective products. A ruling by the Supreme Court that FDA‐approved labeling of pharmaceuticals preempts the reach of the state courts would have severely compromised the balance of power between consumers and producers. (shrink)

Illegal drugs are not inherently unclean, any more than alcohol, tobacco, or canola oil. All of these are simply chemicals that people choose to ingest for enjoyment, and that can harm our health if used to excess. Most of the sordid associations we have with illegal drugs are actually the product of the drug laws: it is because of the laws that drugs are sold on the black market, that Latin American crime bosses are made rich, that (...) government officials are corrupted, and that drug users rob others to buy drugs. (shrink)

To a large extent liability for ICT perils is still a grey area, even though an increasing number of information security researchers adopt economic approaches to highlight market mechanisms and externalities. That is why this article focuses on the need for increased awareness of externalities and liability among ICT professionals and their customers. This is critical to achieve in order to promote appropriate ICT technologies and services with comprehensible privacy and security protection. What is needed is a better (...) understanding of the consequences of externalities from ICT perils. This would benefit customers and increase trust in ICT products and services which in turn may even increase suppliers' profit margin; customers would be prepared to buy more services and products if contracts and service level agreements would accept more liability. Moreover, suppliers could sell guaranties and insurances on top of their products and services. The result would be a win-win situation and would benefit society at large. (shrink)

Gerald Dworkin provides an insightful starting point for determining acceptable paternalism through his commitment to protecting our future autonomy and health from lasting damage. Dworkin grounds his argument in an appeal to inherent goods, which this paper argues is best considered as a commitment to human flourishing. However, socialconnectedness is also fundamental to human flourishing and an important consideration when determining the just limits of paternalistic drug controls, a point missing from Dworkin’ essay. For British philosopher Thomas Hill Green, regulation (...) of alcohol sales emerged from the social ideal. Green argued that policy interventions, including restricted opening hours and locations, improved the conditions for humans to flourish. Green offers a compelling political vision but fails to account for the fact pleasure is also an inherent good. He focused excessively on our social nature, excluding our more pleasure-seeking and egoistic characteristics. In contrast, a more realistic and complete vision of human flourishing can be found in an amended version of Gerald’s Dworkin’s arguments. In conclusion, this paper argues drug policy makers should remain committed to the harm principle as applied to criminal law whereby a person should never be criminalized for self-harm. Such a limit on paternalistic interventions is deemed necessary when eudaimonia is the end of government action. In practical terms, this means that the criminalization of drug use, as opposed to drug production, is always unjust. (shrink)

This article starts from a paradox and aims to solve it. On the one hand, although Drug Courts (DCs) are one of the most interesting penal innovations in recent years, running counter to the dominant retributive approach and the rival approach based on deterrence, they have surprisingly not attracted the attention of philosophers and therefore lack a solid philosophical foundation. On the other hand, although Pickard's ‘responsibility without blame’ approach looks very convincing on paper, its practical applications remain unclear outside (...) the clinical context. I argue that Pickard's approach is the theoretical framework that DCs need and that they are a compelling application of it: DCs do ascribe to participants various forms of responsibility (criminal ‘liability-responsibility’, responsibility of choice, responsibility for progress or failure, responsibility as answerability, tort liability) while striving to keep ‘affective blame’ at bay in order to help them regain their autonomy. However, I argue that some of the limitations of both this approach and DCs become apparent once we consider the ‘outer limits’ of DCs, in other words those who are terminated from DCs and those who refuse to enter DCs in the first place. (shrink)

In September 2012, news broke of a developing drug disaster in the United States. Health authorities had linked a fungal meningitis outbreak to a contaminated steroid made by a company called the New England Compounding Center. The contaminated steroid was a compounded drug that had not been approved by the Food and Drug Administration, differing from three others that had been approved in that it lacked preservatives present in those agents. Factory inspections revealed unsanitary conditions at NECC's drug production facility. (...) By the time the source of the outbreak was identified, an estimated fourteen thousand people had been injected with the drug. As of December 2012, thirty‐nine had died of meningitis, and hundreds more had been diagnosed with meningitis and other drug‐related conditions. Many factors contributed to this disaster. One was a 2002 Supreme Court decision holding that a law prohibiting providers of compounded drugs from promoting their products through advertising and other means impermissibly restricted commercial speech. (shrink)

Sustainable products offered in today’s marketplace are labelled with product-related green attributes or non-product-related green attributes. The current research investigates consumers’ inferences about a product’s functional quality when its core attributes are green and when its peripheral attributes are green. Four experimental studies and an internal meta-analysis show that there is a sustainability liability effect in strength-dependent categories, and a sustainability asset effect in gentleness-dependent categories. Our research contributes to the current understanding of how consumers make inferences about (...) product quality when contemplating different types of green attributes. The findings have implications for how strength-dependent and gentleness-dependent products should be labelled as green. (shrink)

When a doctor writes prescriptions in his office, following consultation with a patient, and receives no compensation other than the normal fee for service, can this still be drug trafficking? Recent courtjudgments have emphatically held that it can, but in so doing courts wrongly impose criminal liability on doctors for trusting patients.

Major depressive disorder (MDD) is a severe mental illness that affects 5 to 20% of the general population. Current antidepressant drugs exerts only a partial clinical efficacy because approximately 30% of depressed patients failed to respond to these drugs and antidepressants produce remission only in 30% of patients. This can be explained by the fact that the complex pathophysiology of depression has not been completely elucidated, and treatments have been mainly developed following the “monoaminergic hypothesis” of depression without (...) considering the key role of other factors involved in the pathogenesis of MDD, such as the role of chronic stress and neuroinflammation. Chronic stress acts as a risk factor for the development of MDD through the impairment of neurotrophins signaling such as brain-derived neurotrophic factor (BDNF) and transforming-growth-factor-β1 (TGF-β1). Stress-induced depressive pathology contributes to altered BDNF level and function in MDD patients and, thereby, an impairment of neuroplasticity at the regional and circuit level. Recent studies demonstrate that aerobic exercise strongly increases BDNF production and it may contribute as a non-pharmacological strategy to improve the treatment of cognitive and affective symptoms in MDD. Here we will provide a general overview on the possible synergism between physical activity and antidepressants in MDD. Physical activity can synergize with antidepressant treatment by rescuing neurotrophin signaling in MDD patients, promoting neuronal health and recovery of function in MDD-related circuits, finally enhancing pharmacotherapeutic response. This synergism might be particularly relevant in elderly patients with late-life depression, a clinical subgroup with an increased risk to develop dementia. (shrink)

Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. Brand firm anti-competitive practices around the leading buprenorphine product Suboxone — including product hops, citizen petitions and Risk Evaluation and Mitigation Strategy abuses — helped to maintain high prices by (...) extending brand exclusivity periods and hindering generic drug entry. Remedies to address costly anti-competitive activities include adoption of the proposed CREATES Act and modernization of the Hatch-Waxman Act by the Congress, and implementation of substantive modifications to the Food and Drug Administration citizen petition filing procedures. Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017. (shrink)