In defense of the fed.
Imagine your typical day: You wake up at 5:30 or 6am, depending on your commute, to reach work at 7am. After going through security and maneuvering your way to your office, you are bombarded with emails and phone calls. Reports need to be completed, meetings need to be attended, communications must be sent to outside locations, and money needs to be found so that the company can run for another day. Lunch is simply a way to keep your mouth occupied while working. Eventually, you leave work at 7pm to continue working at home or to collapse into a heap.
Anyone entrenched in their own daily hustle can relate to what I’ve just described. But what I’ve really described is my summer experience at the Food and Drug Administration (FDA) in Silver Springs, MD.
While most federal agencies are maligned, the FDA appears to be more maligned than usual. This could be a result of the numerous food/drug/device scares that we must deal with as health consumers in a technologically advanced age. But I believe it’s because the FDA is in the middle of a tug-of-war between consumers, manufacturers, and academics. Consumers want protection from injury and death by relying on the FDA stamp of approval, while manufacturers want a faster review process so they can make money as well as protection from litigation by having the FDA stamp of approval. From where I sat, the FDA wants to prevent that next adverse event for just a little while longer. Yet academics stand on the outside of this foray and blame the FDA for not doing an adequate job.
True, one only has to look to our Congress is to realize how poorly any government organization is doing in this time, but I think the naysayers need to understand what it’s like to work for the FDA.
You might believe you worry constantly about your job security, but what you truly fear is being fired or laid off. Now imagine walking into work one day and being told, “Thank you so much for the work you do! We truly appreciate all of your efforts. However, because the U.S. Congress has not approved their budget, we are unsure if we will be able to pay you for the next month.” Clearly the full breadth of meaning behind ‘job security’ has not reached your world.
You might also be irritated with a person in your workplace who is clearly not doing adequate work. If you approach a supervisor and file a complaint, you fully expect to see said person reprimanded and consequently fired if he/she does not correct their behavior; simply put, there are repercussions for questionable behavior. Now imagine receiving a new drug application filled with data that supports the need to approve the drug. However, after reading through it yourself, you notice some possible issues with adverse effects. You decide to approve the drug, but ‘strongly urge’ the manufacturer to continue studying adverse effects in this drug once it reaches the market. You see, you are only allowed to ‘strongly urge’ further study because federal law has not given you the clout to force a manufacturer to comply; essentially, you have filed your complaint but it is entirely possible that repercussions will never occur.
Or perhaps you are a consultant on a 10-year project for another company; while you have fulfilled your duties, the other company has dragged their feet in beginning their project so you’ve been left with nothing to do. After 2 years (making this a 12-year project), you finally receive some results from this company. Yet the data they give you is so incomplete you are unable to do anything of note. Now imagine a drug company is running a 10-year post-approval study but drags their feet in getting started. Imagine that you are employed by the FDA to oversee the progress of this study, but because progress is practically non-existent, you have been reduced to sending reprimands to the drug company, asking for more progress and faster work. It is now becoming a 12-year study, but federal law does not allow you to do more than make recommendations.
The recurring theme here is that our own laws are preventing the FDA from doing more to help. Granted, I met very intelligent and not-so-intelligent people during my stay at the FDA, so there are internal politics that need to be smoothed out before the FDA can operate optimally. But stupid or genius, slow or fast, I respect every single FDA employee for putting up with this idiocy.
We like to complain about the so-called ‘red tape’ that we have to deal with federal agencies, but no one ever complains about the true culprits: the representatives in the government that we vote for who implement this ‘red tape.’ What is essentially a massive cycle of bickering may never end, but you can be sure the FDA is doing what they can.
Originally published at awaitstheday. You can comment here or there.