"Pharmaceutical breakthroughs such as antibiotics and vaccines rank among some of the greatest advancements in human history. Yet exorbitant prices for life-saving drugs, safety recalls affecting tens of millions of Americans, and soaring rates of addiction and overdose on prescription opioids have caused many to lose faith in drug companies. Now, Americans are demanding a national reckoning with a monolithic industry. Pharma introduces brilliant scientists, in-corruptible government regulators, and brave whistleblowers facing off against company executives often blinded by greed. A business that profits from treating ills can create far deadlier problems than it cures. Addictive products are part of the industry's DNA, from the days when corner drugstores sold morphine, heroin, and cocaine, to the past two decades of dangerously overprescribed opioids. Pharma also uncovers the real story of the Sacklers, the family that became one of America's wealthiest from the success of OxyContin, their blockbuster narcotic painkiller at the center of the opioid crisis. Relying on thousands of pages of government and corporate archives, dozens of hours of interviews with insiders, and previously classified FBI files, Posner exposes the secrets of the Sacklers' rise to power--revelations that have long been buried under a byzantine web of interlocking companies with ever-changing names and hidden owners. The unexpected twists and turns of the Sackler family saga are told against the startling chronicle of a powerful industry that sits at the intersection of public health and profits. Pharma reveals how and why American drug companies have put earnings ahead of patients." -- Publisher's description

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.