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The Prescription Drug Epidemic: A Federal Judge's Perspective on the Need for Collaboration and Coor



While the global resolution with the company is subject to approval by the bankruptcy court in the Southern District of New York, one important condition in the resolution is that the company would cease to operate in its current form and would instead emerge from bankruptcy as a public benefit company (PBC) owned by a trust or similar entity designed for the benefit of the American public, to function entirely in the public interest. Indeed, not only will the PBC endeavor to deliver legitimate prescription drugs in a manner as safe as possible, but it will aim to donate, or provide steep discounts for, life-saving overdose rescue drugs and medically assisted treatment medications to communities, and the proceeds of the trust will be directed toward State and local opioid abatement programs. Based on the value that would be conferred to State and local governments through the PBC, the department is willing to credit up to $1.775 billion against the agreed $2 billion forfeiture amount. The department looks forward to working with the creditor groups in the bankruptcy in charting the path forward for this PBC so that its public health goals can be best accomplished.


The Code of Conduct for United States Judges includes the ethical canons that apply to federal judges and provides guidance on their performance of official duties and engagement in a variety of outside activities.




The Prescription Drug Epidemic: A Federal Judge s Perspective



Canon 4A(4). This Canon generally prohibits a judge from mediating a state court matter, except in unusual circumstances (e.g., when a judge is mediating a federal matter that cannot be resolved effectively without addressing the related state court matter).


Anyone who is an officer of the federal judicial system authorized to perform judicial functions is a judge for the purpose of this Code. All judges should comply with this Code except as provided below.


From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient. You may be asking yourself why your healthcare provider would want to prescribe a drug to treat a disease or medical condition that the drug is not approved for. One reason is that there might not be an approved drug to treat your disease or medical condition. Another is that you may have tried all approved treatments without seeing any benefits. In situations like these, you and your healthcare provider may talk about using an approved drug for an unapproved use to treat your disease or medical condition.


It is time to change how we as a society address alcohol and drug misuse and substance use disorders. A national opioid overdose epidemic has captured the attention of the public as well as federal, state, local, and tribal leaders across the country. Ongoing efforts to reform health care and criminal justice systems are creating new opportunities to increase access to prevention and treatment services. Health care reform and parity laws are providing significant opportunities and incentives to address substance misuse and related disorders more effectively in diverse health care settings. At the same time, many states are making changes to drug policies, ranging from mandating use of prescription drug monitoring programs (PDMPs) to eliminating mandatory minimum drug sentences. These changes represent new opportunities to create policies and practices that are more evidence-informed to address health and social problems related to substance misuse.


Expanding access to effective, evidence-based treatments for those with addiction and also less severe substance use disorders is critical, but broader prevention programs and policies are also essential to reduce substance misuse and the pervasive health and social problems caused by it. Although they cannot address the chronic, severe impairments common among individuals with substance use disorders, education, regular monitoring, and even modest legal sanctions may significantly reduce substance misuse in the wider population. Additionally, these measures are cost-effective. Many policies at the federal, state, local, and tribal levels that aim to reduce the harms associated with substance use have proven very effective in preventing and reducing alcohol misuse (e.g., binge drinking) and its consequences. More than 300,000 deaths have been avoided over the past decade simply from the implementation and enforcement of effective policies to reduce underage drinking and DUI.12 Needle/syringe exchange programs also represent effective and cost-effective prevention strategies that have been shown to reduce the transmission of HIV in communities implementing them, without increasing rates of injection drug use. These programs also provide the opportunity to engage people who inject drugs in treatment. These types of effective prevention policies can and should be adapted and extended to reduce the injuries, disabilities, and deaths caused by substance misuse.13


Health care systems can help prevent prescription drug misuse and related substance use disorders by holding staff accountable for safe prescribing of controlled substances, training staff on alternative ways of managing pain and anxiety, and increasing use of PDMPs by pharmacists, physicians, and other providers.


OJJDP partnered with a research team, experts in the field, and other federal agencies to develop the guidelines to support judges and professional court staff, young people with substance use disorders, and their families.


The intention behind both measures is to make prescription drugs more affordable, while enabling drugmakers to maintain a reasonable profit. While most Americans agree that drug prices have become untenable, drugmakers argue that these prices are necessary given the risks involved in researching and developing new treatments. They also say that price negotiations would stifle future innovation.


If Medicare were to adopt a value-based pricing approach for prescription drugs, the assessments informing negotiations would need to be commissioned from an independent organization. Potentially, ICER could fill that role, perhaps along with other academic institutions. Alternatively, the federal government could establish a separate public body.


Because the problem of drugs and crime is much too broad for any single agency to tackle alone, drug courts rely upon the daily communication and cooperation of judges, court personnel, probation, treatment providers, and providers of other social services.


With respect to federal judges, under Article I of the United States Constitution, the House of Representatives has the power to impeach and the Senate the power to hold a trial to determine whether removal is appropriate. The House can impeach a judge with a simple majority vote. However, a judge may only be removed from office following a trial and a vote to convict by a two-thirds majority of the Senate.


While state constitutions vary in their definitions of impeachable offenses, the few recent successful impeachment efforts in states confirm that legislators generally have limited that power to cases of serious ethical and criminal violations. For example, the 1994 removal of Pennsylvania Supreme Court Justice Rolf Larsen involved charges that Larsen had asked a doctor to write fraudulent drug prescriptions, improperly communicated with lawyers and a trial judge about a pending case, and lied under oath. And New Hampshire Supreme Court Justice David Brock was impeached for improper communications in two cases and for lying under oath.


Most Canadians will use some kind of psychoactive substance in their lifetime. Some of the most common in Canada include alcohol, tobacco, prescription medications (such as opioid painkillers or anti-depressant drugs) and cannabis. A smaller number of Canadians use other drugs such as cocaine, heroin, ecstasy, and methamphetamine.


A comprehensive approach to substance use includes regulation and enforcement, and considers the safety needs of the whole community, while acknowledging that the use and sale of drugs may sometimes be associated with crime and violence.Note de bas de page 27Note de bas de page 28 The federal government's regulatory and enforcement activities aim to take a balanced approach, working to reduce the supply of illegal drugs by working to prevent illegal manufacturing, trafficking, and the diversion of substances from medical use and scientific research into the illegal market. Through the CDSS, the Controlled Drugs and Substances Act (CDSA) and its regulations, the Government of Canada works to:


Before passing Proposition 203 in 2010, Arizona voters originally passed a ballot initiative in 1996. However, the initiative stated that doctors would be allowed to write a "prescription" for cannabis. Since cannabis is a Schedule I substance, federal law prohibits its prescription, making the initiative invalid. Medical cannabis "prescriptions" are more often called "recommendations" or "referrals" because of the federal prescription prohibition.


To reduce knowledge gaps that result from the underrepresentation of people of color and LGBTQ individuals in clinical trials of new drugs, state and federal lawmakers along with industry groups are working to make drug trials more diverse.


In the 21st century, the federal government gradually shifted to a drug control policy focused on prevention, treatment, and enforcement. Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health calls for a public health-based approach to addressing SUDs and discusses the importance of building awareness of substance misuse as a public health problem. Public health is the science of preventing disease and injury and promoting and protecting the health of populations and communities. The public health system in the U.S. consists of federal, state, local, tribal and territorial public health agencies, including rural public health agencies, as well as non-governmental organizations and other partners, and is guided by the ten essential services. Public health approaches recognize the multi-faceted nature of substance misuse and focus on addressing the myriad of individual, environmental, and social factors that contribute to SUDs. 2ff7e9595c


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