Utopian Dreams and Regulatory Nightmares

摘要

The Therapeutic Nightmare: The Battle Over the World's Most Controversial Sleeping Pill, by John Abraham and Julie Sheppard, London: Earthscan Publications, 1999. Drug approvals by governments and research and marketing by the pharmaceutical industry frequently come under scrutiny by the mass media, social scientists, and others. A wave of books published in recent years offers competing recommendations for reforming how medicines get to patients; some authors call for a market-based system with increased freedom for the private sector, others advocate a stronger government role as essential for public health. Robert Higgs (1995) of the Independent Institute and Henry Miller (2000) of the Hoover Institution both suggest eliminating or scaling back the US Food and Drug Administration (FDA) by outsourcing some or all of its responsibilities to the private sector. (They are both kinder to the new European Agency for the Evaluation of Medicinal Products, or EMEA, which they see as more responsive to the industry.) In their analyses, patients would be better served by a free market in which the sick—in consultation with physicians—sort through reports to pick the best treatment. Drug certification firms would offer some oversight, though industry would largely self-regulate what products it puts on the market, motivated to meet high standards of product safety by the relentless press of competition.