Dear FDA: You Can Do Better

The Food and Drug Administration (FDA) has long been the subject of much scrutiny. It can sound harsh (gross negligence, oversight on key safety issues, being a lumbering ineffectual beast) but, as it turns out, grievances against the FDA have probably been well placed. A recent report from the Government Accountability Agency (GAO) shed some light on these claims, and yes, the FDA could be doing a better job.

The GAO report focused on the FDA’s drug marketing policies when it came to drugs approved since 2006 and how the drugs were fast-tracked through the FDA’s premarket approval process. You can find the report here.

What Does The Report Say Exactly?

According to the GAO report, the FDA has been incredibly generous with granting premarket approval – when a drug or device is pre-approved for market if it is notably similar to something already out there. Close to a quarter of the drugs approved for the market between October 2006 and January 2015 utilized at least one of the FDA’s fast-track approval programs. Blindly approving drugs for market based on similarities to existing products is an immense oversight in itself, but – believe it or not – it gets worse after they get approved.

The FDA is seriously lacking when it comes to ensuring the safety of prescription drugs once they reach the public. Its data that should be used to track known safety issues is either unreliable, difficult to access or virtually nonexistent, according to the report. The GAO stated that a look into the FDA’s private database showed that, over the past nine years, the safety data was so incomplete, untimely and inaccurate that it all but prevented workers from doing their jobs.

Sure, the FDA has taken steps to improve its incredibly poor data management. Point taken. But, it has taken almost a decade to make some simple organizational changes and it will take serious effort to even come close to making up for the suffering it may have caused due to its pigheadedness.

Why Is It a Big Deal?

We’ll start with the obvious first. If the FDA can’t reliably track down known safety issues, it can’t remove dangerous products from the market or require stronger warnings – and people will continue buying them. Consumers are continually subject to potentially dangerous drugs while the agency meant to regulate them drowns in bureaucracy.

This undoubtedly puts the FDA on a treacherous path. Any failure to keep track of safety issues in drugs that went through the premarket approval process means that reformation of fast-track policies gets overlooked. If there isn’t any data supporting the fact that the FDA keeps approving dangerous drugs, then any chance for fixing the root of the problem falls victim to oversight.

The FDA is capable of doing great things to protect the public, it just needs to make that the priority above all else. I know that sounds idealistic and a bit naïve, but this is definitely one organization that needs to be held to a higher standard. Step up your game, FDA.