Reform, regulation, and pharmaceuticals--the Kefauver-Harris Amendments at 50.

F years ago this month, President John F. Kennedy signed into law the Kefauver– Harris Amendments to the Federal Food, Drug, and Cosmetic Act (see photo). With the stroke of a pen, a threadbare Food and Drug Administration (FDA) was given the authority to require proof of efficacy (rather than just safety) before approving a new drug — a move that laid the groundwork for the phased system of clinical trials that has since served as the infrastructure for the production of knowledge about therapeutics in this country. We often remember the Kefauver– Harris Amendments for the thalidomide scandal that drove their passage in 1962. But there is much we have collectively forgotten about Senator Estes Kefauver (D-TN) and his hearings on administered prices in the drug industry. Many parts of the bill left on Congress’s cutting-room floor in 1962 — and left out of our memories since — have not disappeared but continue to confront those who would ensure access to innovative, safe, efficacious, and affordable therapeutics. By the time Kefauver began his investigation into the pharmaceutical industry in the late 1950s, the escalating expense of lifesaving prescription drugs was illustrating that the free-market approach to medical innovation had costs as well as benefits. From the development of insulin in the 1920s, through the “wonder drug” revolutions of sulfa drugs, steroids, antibiotics, tranquilizers, antipsychotics, and cardiovascular drugs in the ensuing decades, the American pharmaceutical industry had come to play a dominant role in the public understanding of medical science, the economics of patient care, and the rising politics of consumerism. For Kefauver, the “captivity” of the prescription-drug consumer in the face of price gouging and dubious claims of efficacy underscored the need for the state to ensure that innovative industries worked to the benefit of the average American. After 17 months of hearings, in which pharmaceutical executives were openly berated for profiteering and doctors were portrayed as dupes of pharmaceutical President John F. Kennedy Signing the 1962 Kefauver–Harris Amendments. for services does not bring market forces into play. What is needed are reforms that create clear financial incentives that promote value over volume, with active engagement by both consumers and the health care sector. Market-friendly reforms require empowering individuals, armed with good information and nondistorting subsidies, to choose the type of Medicare delivery system they want. Being market-friendly means allowing seniors to buy more expensive plans if they wish, by paying the extra cost out of pocket, or to buy coverage in health plans with more tightly structured delivery systems at lower prices if that’s what suits them. If market-friendly Medicare reform is your aim, a good place to look is the plan proposed by Senator Ron Wyden (D-OR) and Representative (and vice-presidential candidate) Paul Ryan (R-WI) — not the ACA.5