The Conquering Bureaucracy

A new history of the FDA shows how regulators entrenched and extended their own power.

Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA, by Daniel Carpenter, Princeton University Press, 856 pages, $29.95

After spending months in the Amazon sometime in the early 1960s, a young pharmaceutical salesman just wanted to cross an airstrip and board a plane to begin his long journey home. But a Brazilian soldier had a different idea: "You can't come in." 

The salesman pleaded, "I gotta come in!" The soldier pointed his rifle at the young American, unlocked the safety, and repeated, "You can't come in." The drug rep relented: "Oh, now I got it. I can't go in there."

In 1985 that salesman, G. Kirk Raab, was named the president of Genentech, which has since become one of the leaders of the modern biotech industry. But early in Raab's tenure Genentech was dealt an almost crippling blow at a critical stage of its development by the formidable Food and Drug Administration (FDA). In the spring of 1987, a mere suggestion that an advisory panel to the FDA was entertaining doubts about approving Genentech's first blockbuster drug was enough to send the company's stock plummeting, wiping out a quarter of its value overnight. When talking about the incident and its implications, Raab liked to recall his jungle encounter with state power. "The FDA is standing there with a machine gun against the pharmaceutical industry, so you better be their friend rather than their enemy. They are the boss.…They own you body and soul."

The FDA is one of the oldest and most powerful regulatory agencies in the United States. In his massive, magisterial Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA, the Harvard political scientist Daniel Carpenter provides both a history of the agency and an analysis of how it gained and flexed its most important regulatory power, the ability to keep new drugs off the market. Carpenter carefully documents the ways FDA bureaucrats have worked to exploit opportunities to expand their influence and reshape how the drug industry and the medical profession operate.

The precursor to the FDA was launched in 1906, when the Pure Food and Drugs Act bestowed limited regulatory powers on the Department of Agriculture's Bureau of Chemistry, mostly in the identification and removal of impure or misbranded food and drugs used in interstate commerce. Though pressure for the law had been triggered by muck-raking accounts of the food industry, such as Upton Sinclair's bestselling novel The Jungle, the government's chemists were more concerned in those early years with the accuracy of material printed on drug labels.

Back then, "patent" or "proprietary" medicines—direct-to-consumer products heavy on curative claims and light on detailed chemical information—were a major force in American medicine, raking in hundreds of millions of dollars in annual sales and advertising heavily in mass-circulation newspapers and medical journals. Patent medicine manufacturers could be charged with fraud or "misbranding" under the new law, and many were, but that was easy to avoid. As long as the labels did not contain false information about the ingredients or make demonstrably false claims about their effects, the Bureau of Chemistry had no power over them.

So how could people distinguish between quack medicine and quality pharmaceuticals? The American Medical Association (AMA) and the Council on Pharmacy and Chemistry offered some nongovernmental solutions. In 1905, the AMA created the council to evaluate the validity of the claims made on behalf of patent medicines, awarding a "seal of approval" to any drug it regarded as safe and effective. Drugs it deemed unsafe were barred from advertising in the influential Journal of the American Medical Association. The council also published a separate journal that listed and described the new drugs that had won its approval. Regulators at the time often relied on the council for their own analysis.

By the time the Depression hit, officials at the Bureau of Chemistry (which was re-christened the Food and Drug Administration in 1930) were waging an active public relations campaign against patent medicines and lobbying for tougher regulations of drug labels and advertising. The League of Women Voters—a leading consumer advocate of the day—joined the push for broadened regulatory authority. Sympathetic lawmakers came close to passing a bill during Franklin Roosevelt's first term, but drug regulation was not a New Deal priority, and drug makers and self-medication advocates lobbied successfully against the legislation.

Then Dr. Massengill's Elixir Sulfanilamide hit the market in the fall of 1937. Massengill's potion included the essential ingredient in antifreeze, and more than 100 people died from drinking it. The AMA broke the story of the poisonings, but the FDA quickly stepped in to deal with the crisis, grab the spotlight, and set the agenda going forward. FDA officials were soon featured in a "nationwide race with death" as they flew across the country with reporters in tow to seize bottles of Dr. Massengill's evil Elixir.

Initially, the story had been downplayed by the press as a case of southern blacks using a deadly treatment for venereal disease. That was not particularly accurate, since the medicine had been distributed nationally, was marketed as suitable for a wide variety of ailments and patients (especially children, since it was in liquid form), and had claimed a wide range of victims. But the patent medicine industry was particularly strong in the South, and initial reports from both the AMA and Massengill attempted to limit the scope of the problem by emphasizing that one group of patients had been seeing a "Negro" doctor.

That all changed when Secretary of Agriculture Henry A. Wallace distributed photos of a 6-year-old white girl who had died after her mother gave her Dr. Massengill's Elixir to treat strep throat. FDA officials used the occasion to argue that a "governmental licensing system" was needed before any new drug could be distributed. All medications should be brought under the same regulatory umbrella, and no drug should be put on the store shelf or into the medicine cabinet until it had been vetted for safety by the federal government. Congress quickly agreed, and modern drug regulation was born.

The Food, Drugs, and Cosmetics Act of 1938 gave the FDA gatekeeping power over new pharmaceuticals, as well as expanded authority over drug labels and carte blanche to prohibit drugs it deemed dangerous. Agency officials have been using these powers ever since to dictate how the drug industry operates and what modern medicine looks like, not only in the United States but across the globe.

The 1938 statute empowered the FDA to evaluate whether new drugs were safe to use before being released to the public. But what did that mean? Working with a favored set of university professors and drug company researchers, the regulators developed a new system for evaluating drugs. Large, controlled studies displaced doctor testimonials. The AMA ceased being the leading source of information on drug safety, and eventually abandoned its seal-of-approval program altogether. 

 The FDA distrusted medical professionals, leading regulators to aggressively expand their control over drug labels through bureaucratic rulemaking in the 1950s. In addition to examining the words on packages, the FDA required regulators to preapprove all inserts and even marketing brochures before they could be distributed to doctors. Drug manufacturers bristled when field investigators from the FDA began insisting they had the power to review personnel policies at factories, or when regulators required an entirely new approval process (with clinical trials) for lower-dosage versions of already-approved drugs.

Perhaps the most controversial issue arising from the 1938 statute came after the FDA decided to create and apply a cost-benefit test to each drug, rather than merely prohibiting poison. The question was no longer whether you would drop dead from taking a single dose of bad patent medicine. It was whether the positive effects of a drug at a given dosage and over a given course of treatment outweighed the negative effects. This test then opened the door to asking whether a drug under review performed better than placebos or existing drugs on the market. Opponents to this approach argued that drug efficacy, which they distinguished from drug safety, was a case-by-case medical decision outside the scope of the FDA's statutory authority.

But then another scandal struck. In the late 1950s and early '60s, Western Europe was rocked by birth defects caused by the sedative drug thalidomide. The FDA had blocked thalidomide from coming onto the U.S. market out of concern for its safety. The agency was able to exploit that success to win statutory support in 1962 for new powers, including the explicit authority to consider efficacy when reviewing new drugs.

The FDA's entrenched power to keep drugs off the market often operates off the public radar, though interest groups and the media sporadically focus attention on the issue. The Wall Street Journal editorial page has voiced concerns that the agency is too conservative in evaluating new medications. AIDS and cancer patient groups have lobbied for less delay in releasing drugs for treating critical patients.

On one hand, the FDA's approach to pharmacology has created and enforced a culture of research and development that slows the infusion of new drugs into the market. On the other hand, as Carpenter documents, the FDA's review process is sensitive to politics. When Congress or national newspapers take an interest in the fate of a particular drug or class of drugs, they tend to move through the review process more quickly. The FDA worries about damaging its reputation by approving drugs that ultimately prove unsafe or ineffective (as with the popular painkiller Vioxx, which was pulled from the market in 2004 after it was shown to significantly increase the risk of heart attacks and strokes), but administrators also worry about taking heat for delaying the release of promising new cancer drugs. The agency's power and reputation turn on how effectively bureaucrats balance those competing pressures.

One common approach to thinking about bureaucracies and regulatory policy is through "capture theory." Pioneered by political scientists such as Marver Bernstein and economists such as the Nobel laureate George Stigler, capture theory argues that regulatory agencies and policies often end up benefiting most those who are being regulated. Large firms use regulation to put small firms at a competitive disadvantage.

Carpenter's perspective, by contrast, emphasizes the power of the bureaucrats over their domain. FDA officials developed their own ideas about good policy and cultivated a diverse and changing set of political allies to help them put those ideas into practice. The agency was not above taking advantage of (or stoking) public fears of the "doctor's trust" (the AMA) or "unscrupulous" big drug companies to enhance its own reputation and power. FDA Commissioner David Kessler's attempt to regulate cigarettes as a drug in the 1990s without any new statutory authority was thoroughly consistent with the agency's history.

Still, there are limits to the FDA's reach. Nutritional supplements and herbal remedies have largely eluded the agency's grasp; in some ways they're the modern patent medicines. And the regulators have seen political and legal pushback on everything from Kessler's tobacco power grab to the approval pace of AIDS and cancer drugs. Nonetheless, the FDA has accumulated an immense amount of power since it was born. No account of that power—and of the growth of government in general—should neglect the influence of the bureaucrats themselves in extending their own reach. 

Keith E. Whittington ([e-mail]) is the William Nelson Cromwell professor of politics at Princeton University and the author of Political Foundations of Judicial Supremacy (Princeton), Constitutional Construction (Harvard), and Constitutional Interpretation (University Press of Kentucky).