How the FDA Works


This Bayer Pharmaceutical ad from a 1900 magazine highlighted a number of products, including heroin -- "the sedative for coughs."
This Bayer Pharmaceutical ad from a 1900 magazine highlighted a number of products, including heroin -- "the sedative for coughs."
Bettmann/Corbis

Imagine a world where there are no laws regulating the food you eat. Butchers slaughter cows covered in boils and pile the parts on the floor. Rats are free to crawl about the mountains of meat and organs until they die from eating poisoned bread set out by workers. This mixture of diseased beef parts, dead rats and poison is then shoveled into giant grinders and processed with toxic preservatives to make canned meat. If you're lucky, the can is labeled "beef," but it's just as likely to read "chicken" or "pork" [source: Sinclair].

Now, imagine that medicines are just as questionable. Remedies for kidney and liver problems contain alcohol, making things worse instead of better. Crying or colicky babies are dying because the tonic meant to quiet them contains heavy doses of morphine. But you couldn't avoid these ingredients if you tried — they aren't listed on the label [source: McQueeney].

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Sounds pretty terrible, right? Even more disturbing, though, is the fact that none of these scenarios is actually made up. This was reality when the scientific, regulatory and public health agency now known as the Food and Drug Administration (FDA) was born in the early 1900s.

From these beginnings, the FDA has grown to regulate more than just food and drugs. Medical devices, electronics that emit radiation, cosmetics, veterinary products, tobacco and biologics (like vaccines and blood) all fall under the agency's jurisdiction. To monitor these categories, the FDA employed 14,829 total staff as of 2013, many at its Silver Spring, Maryland, headquarters. Its employees come from a wide variety of professions, and they include attorneys, biologists, chemists, engineers, pharmacologists, physicians and statisticians [source: HHS, "About" and FDA, "Career"].

Of course, all these efforts require money — $4.4 billion in 2014, to be exact. Congress and the president authorized $2.6 billion of this funding, while the remaining $1.8 billion came from user fees [source: FDA, "Narrative"]. While this sounds like a lot, it's actually just a small fraction of the nearly $1 trillion budget of the FDA's parent agency, the Department of Health and Human Services [source: HHS, "Budget"].

So is this money well-spent? Decide for yourself as you read more stomach-churning stories about pre-FDA life.

Agency Origins

Harvey Washington Wiley played a key role in implementing regulations to improve sanitation and reduce food adulteration.
Harvey Washington Wiley played a key role in implementing regulations to improve sanitation and reduce food adulteration.
B.M. Clinedinst/Historical/Corbis

They say the easiest way to a man's heart is through his stomach. Turns out, the same can be said about a politician's vote. At the turn of the 20th century, numerous revelations about questionable handling and dangerous additives led Congress to pass a food safety law. Known as the Food and Drugs Act, it eventually led to the creation of the FDA, the United States' oldest federal consumer protection agency.

The origins of the FDA go all the way back to 1862. As the boom of Civil War cannons echoed across the hills of the American South, President Lincoln appointed chemist Charles M. Wetherill to analyze agricultural materials like food, soil and fertilizer in the newly formed Department of Agriculture.

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After some two decades of food adulteration investigations, his successors, Peter Collier and Dr. Harvey W. Wiley, became convinced the country needed a law to regulate food and drug contents and quality. Wiley was particularly proactive, going so far as to recruit a group of healthy young men known as "The Poison Squad" to serve as human lab rats for experiments with common, and often poisonous, food additives. Partly because of Wiley's work, Congress considered more than 100 food and drug bills between 1880 and 1905 [sources: Swann and FDA, "Dates"].

By 1906, however, Congress — heavily influenced by food packing and canning lobbyists — had yet to pass a comprehensive food and drug law. The tipping point was the publication of a novel that was so disgusting, lawmakers had no choice but to act: Upton Sinclair's "The Jungle." Though technically fiction, the novel was based on Sinclair's undercover work in Chicago's meatpacking plants, and it detailed conditions like the rat-infested mystery meat. One of his most famous claims was that workers who fell into the meat hoppers were sometimes ground in with the rest of the meat!

In response to these shocking allegations, President Theodore Roosevelt ordered an investigation that verified all of what Sinclair had claimed — except for the human hamburger part. On June 30, 1906, Congress passed the Food and Drugs Act (also known as the Wiley Act), prohibiting the trade of mislabeled and contaminated food, beverages and medicines across state lines. Wiley's Bureau of Chemistry was tasked with enforcing the new law, making it the first real predecessor of the modern FDA [source: Sinclair and FDA, "Dates"].

Administration Organization

The FDA is like a layer cake -- a delicious layer cake of bureaucracy intended to keep you safe.
The FDA is like a layer cake -- a delicious layer cake of bureaucracy intended to keep you safe.
juliannafunk/iStock/Thinkstock

Like most government entities, the FDA evolved out of several other agencies and experienced some name changes, reorganizations and relocations before it became the agency we know today. For simplicity's (and sanity's) sake, we won't wade too deeply in the nitty-gritty details. Instead, let's focus on two simple questions: How was the modern FDA formed, and how is it organized today?

As we learned in the last section, Congress tasked the Department of Agriculture's Bureau of Chemistry with enforcing the 1906 Food and Drugs Act. To accomplish this task, the agency conducted experiments to inform the regulations they created. In 1927, Congress split these duties between two separate agencies: the Food, Drug and Insecticide Administration (FDIA), which handled the regulations, and the Bureau of Chemistry and Soils, which performed the experiments. Just a few years later, on July 1, 1930, Congress dropped the "insecticide" part and renamed the agency, simply, the Food and Drug Administration. From there, it bounced around under four different parent agencies until 1979, when it finally landed where it is now — under the Department of Health and Human Services [source: National Archives].

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The FDA's organization has certainly changed over its 85-year history, but it's generally been hierarchical; think layers on a cake. Today, the top layer is the Office of the Commissioner of Food and Drugs, which reports directly to the secretary of Health and Human Services. This first layer also includes seven supporting organizations that report to the commissioner and help the agency with high-level administrative tasks like crafting policy, coordinating outreach and handling litigation [source: FDA, "Commissioner"].

The next layer contains the offices of five deputy commissioners who all answer to the commissioner and do most of the agency's heavy lifting. Two of these units, the Office of Foods and Veterinary Medicine and the Office of Medical Products and Tobacco, are responsible for ensuring the safety of specific products. The other three — the Office of Global Regulatory Operations and Policy; the Office of Policy, Planning, Legislation and Analysis; and the Office of Operations — support these efforts by offering policy guidance, drafting legislation, assisting with day-to-day operations and providing other general services. Each of these offices has one or more layers below it, all playing a role in keeping our food, drugs and other products safe [source: FDA, "Organization"].

A Look at Regulation

FDA workers inspect everything from the obvious food and drugs to the unexpected -- items like radiation-emitting products and medical devices.
FDA workers inspect everything from the obvious food and drugs to the unexpected -- items like radiation-emitting products and medical devices.
RGtimeline/iStock/Thinkstock

The FDA oversees a staggering amount of goods sold in the United States. According to one estimate, they're responsible for ensuring the safety of items accounting for 20 cents out of every dollar consumers spend [source: FDA, "Origin"]. Of course, the FDA can't examine every factory and test every product, so they do the best they can with a mix of regulations, guidelines, inspections and approval processes.

All FDA regulations are governed by more than 100 separate laws passed by Congress. One of the most important is the Food, Drug and Cosmetic Act of 1938, which expanded the 1906 law we discussed earlier. This landmark legislation, among other things, created food standards, allowed for factory inspections and forced drug companies to prove their products are safe. Other milestones include the Kefauver-Harris Amendments of 1962, which greatly bolstered drug safety rules, in addition to the Medical Device Amendments of 1976, which improved the safety of medical devices [source: FDA, "Legislation"].

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What, then, is the FDA supposed to regulate? The general categories include foods, drugs, biologics, medical devices, radiation-emitting products, cosmetics, veterinary products and tobacco products. When a regulation is proposed, the FDA accepts public comment before it issues the final rule, which then becomes law. If you've got a lot of free time on your hands, you can check them out in Title 21 of the Code of Federal Regulations. Short of a regulation, the FDA can also issue guidance. This is sort of like the assembly instructions for a piece of furniture: It's the agency's best advice for how a regulation could be carried out, but it doesn't necessarily have to be done that way [source: FDA, "Difference"].

To ensure the regulations are being followed, the FDA may inspect some products and facilities. Agency inspectors visit more than 16,000 facilities per year, including food-processing and drug-manufacturing facilities, dairy farms and even blood banks [source: Swann]. Because the FDA can't examine every facility and product they oversee, they will also conduct impromptu inspections if they receive a specific complaint. Additionally, the agency will approve certain products they've reviewed for safety and effectiveness. Depending on the product regulation, this may be done before or after the item goes on the market. Such "FDA-approved" items include drugs and food additives for people and animals, biologics and high-risk medical devices [sources: FDA, "Inspect" and FDA, "Approved"].

Criticisms and Successes

This upper limb prothesis was created for children exposed to the drug thalidomide in utero.
This upper limb prothesis was created for children exposed to the drug thalidomide in utero.
SSPL/Getty Images

When you turn on the television news these days, there's a good chance you'll hear two pundits having a heated debate about the merits of government regulation. Some feel it's costly and hampers progress while others feel it's necessary to keep businesses honest. As a regulatory agency, the FDA is certainly no stranger to this controversy. A quick look back at the agency's history shows that both sides of the regulation debate have some valid points.

One instance when critics felt FDA regulations slowed progress was during the AIDS epidemic of the 1980s. Little was known about the disease, and for many it was a death sentence. Activists felt the FDA was dragging its feet through the approval process for promising new drugs. The conflict came to a head Oct. 11, 1988, when 1,000 protesters managed to close down the agency's headquarters in Maryland, some holding posters that read, "Time isn't the only thing the FDA is killing" [source: Crimp].

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Others think FDA regulation doesn't go far enough. These critics point to cases like that of Vioxx, a painkiller approved by the agency in 1999. When a 2000 study showed the drug might pose a significant risk for heart attack when compared to a similar painkiller, Vioxx's manufacturer, Merck, shrugged it off. The other drug simply had a highly beneficial effect on the heart, they reasoned. The FDA accepted the argument, and Vioxx remained on the market until 2004, when Merck pulled it amid mounting criticism. By this time, according to one study, Vioxx had caused between 88,000 and 140,000 heart attacks [source: Bhattacharya and Berenson et al.].

Still, the FDA has had some undeniable successes, like its refusal to license the sleeping pill thalidomide in the United States. Developed in Germany, scientists initially viewed the drug as exceedingly safe, approving it for over-the-counter use in most European countries by 1956. In 1961, however, scientists discovered a link between thalidomide and children born with malformed limbs. While such birth defects affected 10,000 children worldwide, the United States was largely spared thanks in large part to resistance from the FDA and, specifically, its drug examiner, Frances Oldham Kelsey [source: Science Museum].

Author's Note: How the FDA Works

When writing about government agencies like the FDA, things can get dry pretty fast. But hidden beneath snooze-worthy policies, regulations and organizational charts are truly fascinating historical events that influenced the agency's development in one way or another. There were so many, in fact, that I couldn't mention them all in the article. There was the story of elixir of sulfanilamide, which killed 107 people, mostly children, and led to the passage of the Federal Food, Drug and Cosmetic Act of 1938. Or the mysterious case of Tylenol capsules laced with cyanide, which led to tamper-resistant packing regulations in 1982. Bureaucracy: It's more interesting than you think!

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More Great Links

Sources

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