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FDA Scientist

The Real Poop

The Food and Drug Administration is huge, HUGE—to paraphrase Mr. Trump of TV and real estate notoriety. Known by one and all as the FDA, this US government agency is a regulatory juggernaut that oversees a big chunk of what American consumers buy and ingest, all for the protection of the health of the US public.

Now, really, how huge is huge? The FDA just happens to mention on its government-issue website that it regulates one trillion dollars’ worth of products. It's got the power, too, to do things like shut down plants for running afoul of safety regulations or recall a popular and profitable drug that just might hurt people. 

And believe us, despite its name, the FDA pays attention to a heck of a lot more than mere food and drugs. It's in charge of overseeing a grab bag of stuff like cosmetics, tobacco, medical devices, infant formulas and even microwaves. Yep, that bowl of macaroni and cheese you nuked the other day has the FDA's fingerprints all over it.

FDA scientists play a huge role in keeping the FDA humming along. These scientists are the bouncers guarding the door of the American marketplace. They check out the products begging to get on the shelves, make sure they're on the up-and-up and decide if they deserve to get in and mingle. Those scientists conduct experiments, review data and make decisions on what products are safe for us to use.

To get the job done, the FDA hires scientists who fall into three broad categories: reviewers, researchers and inspectors. The reviewers review clinical trial data from drug or product companies. Researchers develop and perform experiments to test new products. Inspectors visit the companies and make sure they are following all the rules. You can think of inspectors as schoolmarms with rulers in the school of product regulation, ready to whack the knuckles of companies that might be trying to slack off.

The FDA belongs to the US Health and Human Services Department, and does all this regulatory business to improve public health.

It's been around in one form or another since the mid-19th century, when the agency's main job was to do chemical analysis of agricultural products. Then, the feds began to regulate food and drugs et al., in the early 20th century. A big part of its mission—well, crusade—was protect sometimes-gullible Americans from so-called snake oil salesmen who were hawking "miracle," but often fatally dangerous, elixirs. Federal agents chased down these traveling con artists whose "medicine" bottles never got around to listing ingredients. Often, hapless buyers discovered that a miracle oil made from a snake didn't work one bit, or worse, was really and truly deadly. Eventually, the Bureau of Chemistry got itself a new name—FDA—in the 1930s and eventually grew into the big-time consumer protection agency that it is now.

FDA scientist watchdogs care about safety issues, like making sure that the injury-prone high school soccer player who goes in for an X-ray of a bum ankle doesn't end up with a burn from all the radiation zaps. They see that cosmetics are properly labeled so folks with skin allergies don't end up looking all swollen like the Stay-Puft Marshmallow Man. They look at clinical drug trial data, and decide if the drug is safe enough to be marketed. Being an FDA scientist is a high-stakes job, since what these scientists do directly affects the health of the consumer.

Of the three types of FDA scientists, it's the research scientist who spends a big part of his day doing those stereotypical scientist things. The typical researcher is at the lab bench, doing experiments to test different products. Then he analyzes all that data and puts them into reports and presentations. Researchers have meetings with other scientists, where they discuss a product and the types of results they are getting. They'll also have meetings with the review scientists, explaining what their research says about the product. Think of them as the auto mechanics of the FDA, sliding under the product to check out all its bits and pieces, making sure each part is going to run like it's supposed to.

If the researchers are the lab rats, scientific reviewers are the bookworms. A reviewer spends most of her day at a desk, going through the mountains of paperwork that pharmaceutical and other companies have submitted in the hopes that their product will be approved for the market. A good part of her day is also spent in meetings with researchers or other reviewers, where they'll discuss ideas and whether they're being won over by the applications and their supplicants. When she ultimately reaches a decision about the product, the reviewer writes up reports detailing the recommendations for approving the product. Or, she sends the disappointing news to the pharmaceutical companies that their 10 years of research didn't cut it. You can think of her as the skeptical mother sizing up the date her daughter brought home, warily eyeing that motorcycle in the driveway and figuring out whether it’s a deal-breaker.

Then there's the scientific investigator who gets to travel to the different companies, tour their facilities, and make sure they are following all the government's rules for research and manufacturing a product. It's one thing for the FDA to tell a company it has to make a product a certain way for it to be sold, but it generally helps if you've got people who can actually go and make sure it's being done.

No matter what category FDA scientists belongs to, one thing is clear: They need to have scientific chops, preferably degrees (note the plural) in hard sciences. And since they'll be doing more than gazing into a microscope, they'll need to be able to talk, often to companies whose products the FDA just recalled. Since it's common for all FDA scientists to write reports and give oral presentations, they've got to write and speak science-y well. So much of the job is scientists talking to other scientists, you'll need to have your lingo down pat.

FDA scientists have got to work well under pressure and meet deadlines—companies have millions of dollars at stake on a product, so no spending the afternoon looking at kitten pictures on the Internet when that FDA research report is due. Scientists should also revel in the glory of the tiny detail and the picayune, since their job is to assess the safety and validity of a product.

Because an FDA scientist works for the government, most of the jobs are located in the bustling city of our nation's capital — or to be more specific, in the Maryland suburbs of said city. There's also a research center in Arkansas that hires research scientists, and the Office of Regulatory Affairs that hires regulatory or review scientists nationwide. But if you are looking to get that FDA gig, your best bet is to get ready to rub shoulders with Abe Lincoln's statue in Washington, DC.

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