A Guide to Working at the FDA: Benefits, Challenges and Tips From Former Employees

FDA_Sarah Silbiger/Getty Images

Courtesy of Sarah Silbiger/Getty Images

For professionals in the pharma industry, working at the FDA is largely considered to be a high honor. Despite this, the agency sees a good deal of turnover, with many employees opting to work for private pharma and biotech companies after just a few years.

A 2016 study published in The BMJ found that over one-fourth of the FDA employees who approved cancer and hematology drugs from 2001 through 2010 left the agency to work for pharmaceutical companies. 

There are a few reasons for this–some proven, others speculative. One of the most commonly-cited reasons is a disparity in pay, largely due to a lack of funding. 

The Gap in Pay Relative to Workload

Some of the FDA’s funding issues were absolved with the passing of the Prescription Drug User Fee Act in 1992, allowing the FDA to accept money from pharma companies submitting drugs or medical devices for approval in the form of prescription drug user fees. But as the agency is still partially funded by taxpayers, employee wages are pre-determined, with little room for negotiation. 

This is one reason Peter Pitts, the president and co-founder of the Center for Medicine in the Public Interest, left the FDA about 20 years ago after working there for two years. While there, he was the associate commissioner for external relations, serving as senior communications and policy adviser to the commissioner.

“One of the reasons I left the agency, but not the only reason, was that I had two children who were starting to look at colleges,” Pitts told BioSpace. “That's a very expensive proposition, and quite frankly, I needed more money.”

Another reason Pitts decided to leave the regulatory agency was the workload. 

“It’s an incredibly intense experience–you really are working 15 hours a day, seven days a week,” Pitts explained. And he wasn’t the only one. 

“The parking lot was filled seven days a week, so I was not the only one working all the time. The people who work there, whether they're political appointees or career officials, which is the overwhelming majority, are just amazingly committed to the agency and its mission,” Pitts added, joking that “it's almost like a religious cult.”

Even so, Pitts said he considers his time at the agency to be the highlight of his career. He didn’t need outside motivation to go to work–to him, the work was the reward. 

“Every second that I was on that job, I recognized I was doing something urgently important to advance and protect American public health, and that was incredibly satisfying. And I don't think that you can get that type of satisfaction from the private sector. Government service really gives you the opportunity to make a difference.”

Deb Autor worked at the FDA for 12 years, from 2001 to 2013. While there, she served as the director of the Office of Compliance and the Center for Drugs and as the deputy commissioner for global operations and policy. She agreed with Pitts in that although the workload was heavy, the learning opportunities at the agency were unmatched. 

“At the FDA, you're learning not only the substance, but how to operate in the broader governmental context and in an even broader ecosystem consisting of patients, healthcare providers, industry and essentially, all of the American public,” Autor told BioSpace.

Autor left for a different reason than Pitts–to get a different perspective. 

“I had spent most of my career in the government and I wanted to really understand the industry side of the equation. I see it as all one big ecosystem,” Autor said. “And I thought that I could really broaden my perspective by having that different vantage point of being in the industry.”

Hurdles and How to Overcome Them

There are myriad reasons professionals in the industry would want to work at the FDA, including how it looks on a resume and the effect it can have on the rest of one’s career. Even so, the agency constantly has vacant positions, with 62 listed as of this writing. 

Autor explained that this could be partially due to the wait time in the FDA’s hiring process. She said that though processes have improved in recent years, it can still take longer to be hired at the FDA than at a private agency. Pitts concurred, adding that for the first few weeks at the agency, he worked as a consultant, waiting for all of his paperwork to be done. 

In an agency full of political appointees and professionals at the peak of their careers, getting hired is just the first step. After that, one has to be able to keep up.

“I think for people that want to make a career or get jobs inside the FDA, there is a high intimidation factor that they have to somehow recognize, internalize and get past,” Pitts said. 

Part of getting past that element of fear, Pitts said, is being able to ask for help. He said when he was able to acknowledge his ignorance and ask for help, his colleagues at the FDA reacted much differently than he expected. 

“When I asked what I assumed were dumb questions, I was never turned away. I always got a very thoughtful, friendly, understandable response,” Pitts said. “And that is not always the case in private industry, where that’s viewed as weakness.”

While common in many government jobs, both Pitts and Autor said bureaucratic hurdles are inevitable at the FDA. 

“I think it's the nature of working in a regulatory agency,” Autor said. “You have to be conscious of the political and public views on what you're doing.”

And there are many views about those who work at the FDA, especially those who go on to work for private pharma or biotech giants that they previously worked to regulate. 

But, she added, it’s worth it. 

“While that can be challenging, it's also kind of one of the things that actually makes the job more interesting and strategic, because you really do have to think broadly about so many stakeholders and figure out how to be successful and have an impact in that environment.”

The best thing a professional can do when considering a position at the FDA is to weigh the pros and cons before making the decision. And while the negative aspects may seem daunting, neither Pitts nor Autor regrets their time at the FDA.

“It's an amazing place to work and an opportunity of a lifetime,” Autor said. “I've had great roles in and out of the FDA and government, but I have to admit, the most fun I had in my career was at the FDA.”

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