The current system of drug regulation is, literally, overkill and works against the public interest,” declares Hoover Senior Research Fellow Henry I. Miller in his new book, To America's Health: A Proposal to Reform the Food and Drug Administration (Hoover Institution Press, 2000).
In an era in which scientific advances regularly produce lifesaving new medicines, the FDA has become, Miller argues, an obstacle to the availability of important therapeutics to patients who need them. As he explains, inefficient and excessive regulation, built on a bureaucratic culture of risk aversion, has crippled the FDA. Attempts at regulatory reform have been weak, undermined by the absence of any constituency that demands improvements in our regulatory system.
Citing evidence of distorted incentives to government regulators–and dozens of studies calling for changes in drug regulation–Miller proposes straightforward reforms to alter those incentives in ways that will get more drugs to patients, less expensively and in a shorter time. He suggests shifting much of the responsibility for oversight of drug testing and review to nongovernmental, FDA-certified groups to create a more efficient drug review process, which, in turn, will spur drug companies to pursue greater innovation in drug development.
Miller's lucid and well-documented book calls for the kind of fundamental change in governmental thinking that would be a boon to all Americans.
Henry I. Miller, M.S., M.D., is a Senior Research Fellow at the Hoover Institution. His research focuses on science and technology and their regulation. From 1979 to 1994, Miller worked at the Food and Drug Administration in a number of posts involved with biotechnology. He was the medical reviewer for the first genetically engineered drugs evaluated by the FDA and was instrumental in the rapid licensing of human insulin and human growth hormone.
The Hoover Institution, founded at Stanford University in 1919 by Herbert Hoover, who went on to become the 31st president of the United States, is an interdisciplinary research center for advanced study on domestic and international affairs.