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.

"David Wessel's incredible tale of how Washington works-and why the rich keep getting richer-starts when a Silicon Valley entrepreneur concocts an idea that will save money on his taxes and spins it as a way to ostensibly help poor people. He organizes and pays for an effective lobbying effort that pushes his idea into law with little scrutiny or fine-tuning by congressional or Treasury tax experts-and few safeguards against abuse. With an unbeatable pair of high-profile sponsors, bumper-sticker simplicity and deft political marketing, the Opportunity Zone became an unnoticed part of the 2017 Trump tax bill. The gold rush followed immediately thereafter. In Only the Rich Can Play, Wessel follows the money to see who profited from this plan that was supposed to spur development of blighted areas and help people out of poverty: the Mandalay Bay Hotel in Las Vegas, the Portland (Oregon) Ritz-Carlton, the Mall of America, and self-storage facilities-lucrative areas where the one percent can park money profitably and avoid capital gains taxes. And the best part: unlike other provisions for eliminating capital gains taxes (inheritance, for example) you don't have to die to take advantage of this one. Wessel provides vivid portraits of the proselytizers, political influencers, motivational speakers, consultants, real estate dealmakers, and individual money-seekers looking to take advantage of this twenty-first century bonanza. He looks at places for which Opportunity Zones were supposedly designed (Baltimore, for example) and how little money they've drawn. And he finds a couple of places (Erie, PA) where zones are actually doing what they were supposed to, a lesson on how a better designed program might have helped more left-behind places. Readers will feel outraged as Wessel gives us the gritty reality, the dark underbelly of a system tilted in favor of the few, with the many left out in the cold"--