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Under Review: Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation
By Philip J. Hilts
Alfred A. Knof, New York, 2003, $19.95

Over the course of just a few months last year, Americans learned that the U.S. Food and Drug Administration had underestimated the severity of manufacturing problems at Chiron, one of the nation’s leading flu vaccine suppliers; had misunderstood the heightened risk of suicide among children taking certain antidepressants; and had failed to publicize the correlation between deadly heart problems and the blockbuster medicines Vioxx, Celebrex, and Bextra.

President Theodore Roosevelt, who established the agency that would later become the FDA, knew that managing the expectations of a population that both loved and distrusted pharmaceuticals (and the companies that make them) represented a daunting challenge. But he reckoned that if America’s medicines regulator succeeded more often than it failed, the public good would be served. The FDA has succeeded more often than it has failed, and the American public – and the drug industry – have benefited hugely. But the agency’s failures have a way of overshadowing its triumphs.

During the Clinton administration, critics carped that the agency and its overzealous MDs and PhDs were overstepping their mandate, erring on the side of caution to the detriment of patients. Among other things, politicians and drug industry executives argued that the FDA was taking too long to review new drug applications. These same critics said long review times were bad for business and patients alike.

“Reforming” the FDA became a top policy objective during the “Republican revolution” led by then Speaker of the House Newt Gingrich during the mid-1990s. Then, in the early days of the Bush administration, the FDA went under the management consultant’s knife and emerged talking a new kind of language. Achieving “excellence in management practices,” “modernizing IT,” and striving for “efficient risk management” became the new imperatives at the FDA. Management would be “de-layered” – all to “reduce average time to marketing approval” for new medi­cines and medical devices.

This new mantra at the FDA, however, seems to have distracted the agency from that other “core competency” product safety, resulting in a string of dangerous miscalculations.

A different set of critics this time – the media, government-watchdog groups, the medical establishment, even FDA scientists and advisors – are now saying that the agency has tilted too far in the other direction, overemphasizing product-review speed and industry accommodation and sacrificing patient safety issues that come up after drugs have been approved. One of the FDA’s own scientists, a mid-level staffer named David Graham, testified before Congress in November that the Vioxx fiasco was preventable. He revealed that his employer took the assurances of Merck, the drug’s manufacturer, over the warnings of its own senior scientists and advisors. Graham told Congress that as many as 139,000 patients suffered heart problems – 55,000 of whom may have died – as a result of taking Vioxx. And he said both Merck and the FDA are to blame. The only way to prevent future fiascoes, Graham testified, is to create an independent drug-safety review board whose sole responsibility would be to monitor products after they reach the market. He noted that the system at the FDA for catching problems with marketed drugs is largely voluntary and relies upon doctor and drug company reports that are often slow in coming or incomplete.

Within days of Graham’s bombshell, an editorial on the website of the Journal of the American Medical Association reiterated that the FDA is badly in need of an “adverse drug reaction” reporting system whose success does not depend on drug companies to draw attention to problems associated with their big moneymakers. In most cases, after all, there is a disincentive to be honest and swift about product problems. Investors don’t like this kind of product surprise. Last September, the day after Merck announced it was pulling Vioxx, Wall Street erased $27 billion from the firm’s market value; in December, the day Pfizer announced that Celebrex, too, causes heart problems, investors took back $25 billion. Liability specialists reckon Merck will lose another $18 billion to $20 billion settling personal injury suits.

These are dark days indeed for the FDA. But they will pass, and the FDA will press on in its thankless task of keeping America safe from bad drugs, devices, and food. At least this is the lesson that history tells. To hear Philip J. Hilts tell it, the FDA has endured worse. Hilts explains in his well-timed book Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation that controversy and criticism have dogged the FDA ever since it was created to take on tainted food and patent medicine peddlers. It survives because it must.


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