Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

The new "2008 Red Book" not only presents the latest pricing and product information on more than 160,000 prescription and over-the-counter items, but also a complete list of newly FDA-approved brands, generics, and biologics.

Roger Bate has spend years on the trail of counterfeit medicines in Asia, Africa, and the Middle East, learning the anatomy of a nebulous, far-reaching black market that has resulted in countless deaths and injuries around the world. Phake: The Deadly World of Falsified and Substandard Medicines is the culmination of Bate's research and travels—both a fascinating first hand account of the counterfeit drug trade and an incisive policy analysis with important ramifications for decision makers in the U.S. Food and Drug Administration and the international World Health Organization.

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

The Sixth Edition of this best-selling text includes updates to account for new legal, regulatory and policy developments. Pharmacy Practice and the Law, Sixth Edition provides background, history and discussion of the law so as to enable the student to not only learn the facts, but to help them understand, apply and critically evaluate the information. The issues covered in this text are discussed in non-legal, easy to understand language. Challenging open-ended discussion questions and edited cases are included in every chapter to facilitate discussion and critical thinking. Citations to all laws, court cases, regulations and other documents are provided. An online instructor’s manual is available. Pharmacy Practice and the Law, Sixth Edition, is a useful resource both for teaching the facts of pharmacy law and for stimulating critical thinking issues in pharmacy law.

The incredible true story of the decade-long quest to bring down Paul Le Roux—the creator of a frighteningly powerful Internet-enabled cartel who merged the ruthlessness of a drug lord with the technological savvy of a Silicon Valley entrepreneur. “A tour de force of shoe-leather reporting—undertaken, amid threats and menacing, at considerable personal risk.”—Los Angeles Times NAMED ONE OF THE BEST BOOKS OF THE YEAR BY The New York Times Book Review • NPR • Evening Standard • Kirkus Reviews It all started as an online prescription drug network, supplying hundreds of millions of dollars’ worth of painkillers to American customers. It would not stop there. Before long, the business had turned into a sprawling multinational conglomerate engaged in almost every conceivable aspect of criminal mayhem. Yachts carrying $100 million in cocaine. Safe houses in Hong Kong filled with gold bars. Shipments of methamphetamine from North Korea. Weapons deals with Iran. Mercenary armies in Somalia. Teams of hit men in the Philippines. Encryption programs so advanced that the government could not break them. The man behind it all, pulling the strings from a laptop in Manila, was Paul Calder Le Roux—a reclusive programmer turned criminal genius who could only exist in the networked world of the twenty-first century, and the kind of self-made crime boss that American law enforcement had never imagined. For half a decade, DEA agents played a global game of cat-and-mouse with Le Roux as he left terror and chaos in his wake. Each time they came close, he would slip away. It would take relentless investigative work, and a shocking betrayal from within his organization, to catch him. And when he was finally caught, the story turned again, as Le Roux struck a deal to bring down his own organization and the people he had once employed. Award-winning investigative journalist Evan Ratliff spent four years piecing together this intricate puzzle, chasing Le Roux’s empire and his shadowy henchmen around the world, conducting hundreds of interviews and uncovering thousands of documents. The result is a riveting, unprecedented account of a crime boss built by and for the digital age. Praise for The Mastermind “The Mastermind is true crime at its most stark and vivid depiction. Evan Ratliff’s work is well done from beginning to end, paralleling his investigative work with the work of the many federal agents developing the case against LeRoux.”—San Francisco Book Review (five stars) “A wholly engrossing story that joins the worlds of El Chapo and Edward Snowden; both disturbing and memorable.”—Kirkus Reviews (starred review)