To get a sense of just how important the FDA is to America’s economy, consider that the agency is responsible for the regulation and oversight of nearly a fifth of all consumer expenditures in the country. The agency is not merely responsible for the health and well-being of 300 million Americans; it is also essentially responsible for the good behavior of one of the most powerful industries ever created – the American drug industry. There are bound to be misadventures. It’s a wonder that there aren’t more. In 2003 alone, close to three and a half billion prescriptions were dispensed in the United States.
Contrary to what some are now suggesting, however, America does not need a new medicines regulator or a new bureaucracy to oversee the FDA. What America needs is President Bush and the Republican-led Congress to give the FDA the tools, authority, and freedom it needs to succeed. In short, what America needs is a better understanding of the FDA.The agency is overworked, underfunded, poorly managed, and shamefully politicized. It has just 10,700 employees to evaluate and oversee the safety, effectiveness, and promotion of hundreds of thousands of medicines, medical and radiological devices, dietary supplements, food products, and cosmetics. There are around 100,000 drug companies to monitor and more than nine million channels through which food, medical, and cosmetic products are imported. With an annual budget of $1.5 billion, the FDA is responsible for overseeing nearly $1.5 trillion worth of products. And it has been forced to do so with only a whisper of leadership. Over the past four years, the FDA has had a bona fide commissioner for all of 16 months. Over the past 40 years, the average tenure of an FDA commissioner has been four years and five months.
Curiously, consumers on the whole seem satisfied. But as Hilts writes in his insightful and edgy history, nobody stops to think much about the FDA until he or she suffers the real or perceived side effects of its real or perceived failures. Yet other than the military, has any government institution done more to protect the nation against bodily harm? Doubtful, but because the FDA has always been the subject of ideological attacks, it is judged more for its shortcomings than for its quiet successes.
“In some circles, the fashion is still to criticize the ‘government’ and the ‘government regulators’ as if they were occupying armies rather than citizen-soldiers,” writes Hilts. “The FDA has nevertheless proved itself an essential part of modern society. Its history demonstrates that regulatory agencies can not only establish effective protections but make high scientific standards the starting point for industry.”
Hilts tells us that when enemies of the FDA are not actively trying to legislate the agency out of existence, they are attempting to marginalize it by cutting its funding and curbing its authority. No other health-related government agency is forced to do so much with so little money or power. Today, for example, the National Institutes of Health, the government’s medical-research arm that regulates no industry and is responsible for nobody’s health or well-being, operates on a budget of close to $28 billion a year, while the FDA must make do with about one-twentieth of that amount of money. The FDA’s budget is about one-fifth that of the Environmental Protection Agency, which is only responsible for some aspects of public health.
Yet much is demanded of the agency. The politicians who are not trying to upend the FDA want it to help curb health-care costs and foster medical innovation. Industry wants the agency to speed up the approval process, which now takes, on average, less than 12 months, and to reform protocol to take into account clinical-trial innovations. Watchdogs (including the federal government’s own Government Accountability Office) want the FDA to act more proactively and decisively on such matters as food safety, alternative medicine, and industry shenanigans connected to political contributions and the $2.7 billion direct-to-consumer advertising juggernaut. Health insurers want the FDA to create a regulatory pathway for generic medicines, against the will of proprietary drug companies.
The American Medical Association and the Association of American Medical Colleges are demanding that the FDA figure out how to create a public registry for clinical-trial data without invading the privacy of patients or revealing confidential product information. And such distinguished observers as Science editor in chief Donald Kennedy, who served as commissioner of the FDA from 1977 to 1979, want the FDA to create and enforce a system that can “detect things that go wrong with an already-marketed drug.”
Writing in the December 3, 2004, edition of Science, Kennedy asserts that in light of the Vioxx scandal, the most useful and important new tool Congress could give the FDA would be a centralized system for tracking how much of a given drug is being used per patient and over how much time, so that a denominator could be established and an adverse reaction rate calculated. He and others have noted that Kaiser Permanente has just such a system in place, which allowed the health insurer to spot the Vioxx problem early through the use of adverse-reaction epidemiology studies. “Instead of complaining about the FDA,” Kennedy writes, “Congress should fund it to support an effective Office of Drug Safety, with the authority needed to encourage physician reporting and a way to audit prescriptions.”
Unlike most FDA finger-waggers, Kennedy acknowledges that what needs to be done and what can be done are quite different. Kaiser, he says, can create a centralized database of patient records, for example, because customers willingly entrust their privacy to Kaiser. The United Kingdom is able to create a national health-records registry not necessarily because the population trusts the government – rather the contrary – but because it’s the law, and the law was passed in Parliament on the promise that it will improve for all what had become an abysmal health-care system that served nobody particularly well.
“If we were to try and give the FDA something like these two systems,” Kennedy says, “you’d hear cries of privacy invasion.” But this is a chasm we must eventually cross. Privacy advocates and antigovernment critics will object, but eventually America will find a way to link the FDA to patient records. National health-record databases are the future. Last year, the United Kingdom began to build a lifelong health-records database for the 50 million patients in its public-health system, which is linked to 30,000 general practitioners and 270 hospitals and clinics in the U.K. Sweden, Denmark, and Japan are talking about the feasibility of creating similar databases in their own countries. Growing populations with new and more complicated health needs will force the matter. No government agency is in a better position than the FDA to manage such a database.