FDA FOIA Requests: A Deeper Look into Key Challenges and Stats

Freedom of Information Act (FOIA) requests to the U.S. Food and Drug Administration (FDA) serve a critical function. Through them, people can access records the FDA doesn’t voluntarily make public. Given that the FDA ensures foods, drugs, vaccines, cosmetics, and many other staples of our daily lives are safe, there’s bound to be important information in those records that the public ought to know.

But when faced with having to respond to thousands of FOIA requests each year, including some that require producing hundreds of thousands of pages, compiling information for its responses to these requests is as time-consuming and painstaking for the FDA as clearing out the 10,000 unread emails in your email account is for you. There could be many reasons for delays in responding, such as a lack of resources, inefficient processes, bureaucratic red tape, and outdated technology.

As a result, requesters can end up receiving responses to their requests too late for their purposes, rendering the information useless. Not to mention, the FDA’s own inefficiency wastes its limited resources.

In this post, we examine recent FDA FOIA request data, including how quickly the agency responds to requesters. We then examine how advancements in eDiscovery software could help the FDA streamline its FOIA response process.

FDA FOIA Requests: The Big Picture

According to a study from Epstein Becker & Green, over the past ten years, the FDA addressed about 97,000 out of 119,000 FDA FOIA requests, or roughly 80 percent, within 200 days of submission. The FDA addressed roughly eight percent of requests within between 200 days and 400 days. Finally, about 12 percent of the time, requests remained open for more than 400 days.

Keep in mind that FOIA requires federal agencies to issue determinations about the information requesters are seeking within 20 working days, but they can request a 10-working-day extension and can negotiate the response time with the requester when responding will take longer than 30 working days.

Addressing 80 percent of FOIA requests within 200 days may sound like an accomplishment, but 200 days is almost seven months. That’s plenty of time for information to go stale or for the reason for the request to no longer be timely. Of course, if a request goes stale after 200 days, the 12 percent of requests that are addressed after 400 days — 13 months — might practically be mummified by the time the FDA gets to them.

(For those of you scoring at home, the Epstein Becker attorney received most of the data he requested within 21 days.)

According to the FDA FOIA request data, the FDA’s most frequent FOIA requesters were entities such as FDA News, Merck, Thomson Reuters, and Bloomberg News. These requesters and many others are journalists and researchers who often investigate matters related to the FDA, publicize data that could challenge existing policies, and seek information from the FDA that can advance public discourse. Others are companies regulated by the FDA seeking information that could impact their business decisions, including which drugs to seek regulatory approval for.

For these and other requesters, as the Epstein Becker blog notes, waiting over a year for a response to an FDA FOIA request often renders the information useless.

But FOIA requests are all about finding and sharing data, so there must be a way for the FDA to avoid that huge backlog, right?

The FDA’s Potential Challenges with FOIA Requests

Traditional FOIA request methods involve government agency personnel:

1. Finding records in response to a request
2. Reviewing those records to determine relevance
3. Deciding which documents will be released to the public
4. Redacting personally identifiable information (PII), protected health information (PHI), and data protected from disclosure by one of FOIA’s nine exemptions.

Without modern technology to sort documents and filter for relevance, it’s almost impossible for agencies like the FDA to use a standardized, efficient, and repeatable process for responding to records requests.

This manual approach makes the FDA FOIA request process time-consuming and frustrating for requesters who cannot move forward with their projects until they hear back from the FDA. It can also make the process expensive if they need to explore other — perhaps costly — sources of similar information because they cannot afford to wait any longer for the FDA to respond.

How Discovery Software Can Streamline FOIA Requests for the FDA

The funny thing is, that responding to FDA FOIA requests involves a process very similar to conducting eDiscovery. Could the FDA and other agencies responding to FOIA requests leverage existing discovery software to accelerate their process?

Of course, they could.

(How else would you expect an eDiscovery blog to answer that question?)

eDiscovery software like Logikcull can streamline the FDA FOIA request process by allowing FDA personnel to quickly find and organize relevant documents in all of their forms (including text messages, social media records, etc.), redact any exempted information automatically, and produce them in formats that can be easily ingested by the requester.

For example, whether a potential response is fifty pages or fifty thousand pages, with a tool like Logikcull, the FDA can upload its data, have it automatically sorted, and filter it by relevant criteria so that agency staff members can hone in on responsive documents quickly. The technology also spots any type of PII and can redact it in bulk across an entire project. This dramatically reduces the manual review of records and expedites the response process.

Conclusion

Slow and steady might be a winning strategy for cultivating a nice garden, but it’s not a winning strategy for responding to FOIA requests.

The FDA’s slow FOIA response times prevent the release of information relevant to U.S. citizens and force journalists, researchers, and others to miss opportunities to hold the FDA and the parties that interact with it accountable for their actions or to disclose relevant information.

Modern discovery solutions can help the FDA and other government agencies respond to FOIA requests in a timely fashion and reduce the inefficiencies within the FDA’s current FOIA request-response process.

If you’d like to see how Logikcull’s software can make records requests night-and-day easier, book a demo with us today.