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.

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  • SIV||

    There are no babies in that bathwater.

  • mr simple||

    So, was the book any good?

  • ||

    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.

    And so the main mission of the FDA was a failure right from the beginning. Hooray for Snake Oil and Fine Print!!! *Three Cheers*

  • BWM||

    Putting false information in the fine print was still illegal.

  • ||

    ...completely missing the point how they can lie in the Big Print and then people won't even read the Fine Print...but yeah, the FDA has clearly done us a world of good. Now, where'd I put my Enzyte and FatBlockerBurner2000, dammit.

  • Colonel_Angus||

    FatBlockerBurner2000 sounds like it would go good with FourLoko.

  • ||

    Wasted, Hyper, and Super Slim, now THAT'S what I'm talkin bout, wooo!

  • ||

    Sympathetic lawmakers came close to passing a bill during Franklin Roosevelt’s first term, but drug regulation was not a New Deal priority

    Shortsighted fools, blind to the infinite possibilities.

  • Almanian||

    removal of impure or misbranded food and drugs used in interstate commerce

    Interstate Commerce - Where All 'Good Government'™ Gets Its Start!

  • ||

    Perhaps the most accurate Onion Radio News story ever:
    Drugs Now Legal if User is Employed

  • SIV||

    The Dr. Massengill’s Elixir Sulfanilamide poisoning epidemic resulted in the government restricting the very effective sulfanilamide drug while the poisonous diethylene glycol remained freely available without a prescription.

  • BakedPenguin||

    The FDA sure didn't poison any of the test subjects at Tuskegee with sulfa drugs.

    Hooray for government!

  • ||

    The probem was they didn't use sulfala antibiotics nor penicillin. The plan was to observe the progression of syphilis until death.

  • ||

    The bigger problem is that they never told them about it. But hey, they got themselves some free healthcare right?

    http://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment

  • jerbigge||

    I believe the diethylene glycol was used to dissolve the sulfanilamide. Plus it tastes "sweet" and that was perhaps considered a "plus". It is what is used today as antifreeze and also increases the boiling point so it is used year around now. It is also poisonous and marked so on the container.

  • BakedPenguin||

    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.

    ...on a brighter note, his douches took the nation by storm.

  • Hundocumented||

    ... and the main ingredient of that was?

  • Pud||

    Tuna

  • GMT II||

    Lookie, lookie...it's Taco Tuesday!

  • Jen||

    Tony's reasoning.

  • Robert||

    I'm glad somebody's pointing out that FDA was already taking efficacy into account in making safety determinations before the 1962 amendment formally took separate account of efficacy. I've seen opinion in favor of repealing the efficacy requirement for drugs & devices, but they don't realize that'd just mean FDA would go back to making efficacy part of the safety determination -- because how else could safety be determined for inherently dangerous medical articles, except relative to efficacy?

  • ||

    The " machine gun against the pharmaceutical industry" is pretty accurate, figuratively, but usually FDA inspectors only carry pistols during inspections at pharmaceutical companies.

    The most unusual abuse of power I saw during my years in the pharmaceutical industry was the time an FDA reviewer decided that our company should run a very expensive clinical study which would address his personal curiosity about an aspect of human physiology which he admitted was not particularly relevant to the safety or effectiveness of the drug being studied.

  • JRD||

    What an uplifting tale of aggressive government regulation saving lives that otherwise would have been sacrificed on the altar of the "free" market.

  • ||

    The abuse of power in the FDA has resulted in delaying vital medicines reaching the public, increasing the costs of medicines.

    On the flip side, the FDA is extremely slow to remove medicines proved to be dangerous - particularly when it benefits favored drug companies.

    Congress is supposed to oversee the functioning and effectiveness of the FDA. The abuses in the pharmaceutical industry, and collusion with hedge funds are mostly being ignored by Congress and the SEC.

    At the Bernie Madoff hearings, one of the witnesses stated that both the SEC and the FDA were "captured" agencies. Congress - get control of the crooks in the pharmaceutical sector!

  • qualir||

    1790, the German Baron von Grimm declared: "We are obsessed by the idea of regulation, and our Masters of Requests refuse to understand that there is an infinity of things in a great state with which a government should not concern itself."

  • Wes Simmons||

    The FDA has access to most likely all statistical data from a pharmaceutical company. Which in turn means upper brass FDA employees are buying stock in companies they are helping 'approve' or 'disapprove' . Most likely they analyze what is in the proposed drug, what the companies marketing strategies are, and their reputation. Pharmaceutical companies are not in the business for making 20 or 30 dollars. They are there to 'cash in and cut'. So why shouldn't the FDA get in on it too. On the back end the FDA/government can also see the effects of certain drugs on human subjects without taking the 'heat' from human rights activist groups. I am not a chemist or medical expert but I am willing to bet money that newly found drugs are a derivative/offshoot of illegal ones. The poster boys are the pharmaceutical companies. They supply all the marketing and media muscle. And pardon my language, when the 'shit hits the fan' they get the bad press.

    My favorite FDA classification/category is the Diet Supplement area. This area is so grey ,yet these pharmaceutical companies are making a boatload of cash in it.

    I recall a supplement which I believe was called androstene. A very famous baseball player named Mark McGwire took mass amounts of this supplement and broke a long standing homerun record. I remember asking a body building acquaintance of mine about the supplement and if it was a form of steroids. His reply, "Androstene is a molecule away from steroids....and come on...how big is a molecule?'

    One market feeds another. Too much money at stake. Terminal illness patients desperate for cures, athletes looking to boost their stats and lucrative contracts, the list goes on and on.

  • shiroi neko||

    that's true.

  • nike shoes UK||

    is good

  • رش مبيدات||

    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.
    شركة تنظيف فلل بالرياض
    And so the main mission of the FDA was a failure right from the beginning. Hooray for Snake Oil and Fine Print!!! *Three Cheers*

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