FOIA & the FDA: Data analysis

Table of Contents


Under pressure - FDA oversight, funding, effectiveness: A webcast of this panel at Health Journalism 2008 is available.

Working your way through the FDA: Julie Zawisza, assistant commissioner for public affairs at the FDA gave this presentation at Health Journalism 2008.

FDA's FOIA contacts

FDA public affairs list of who to contact about specific topics (PDF)

Handbook for requesting information and records from FDA

FDA newsroom

FDA Press Office contacts

FDA's regional public affairs specialists

Sign up for FDA e-mail alerts

FDA's Freedom of Information Annual Report - FY 2007


The overarching theme of the data suggests the following:

  1. Many reporters haven't made a FOIA request with the FDA in the last five years;
  2. Reporter are generally unhappy with their experiences when submitting requests to the FDA;
  3. Reporters rarely make those requests in person, follow up with other potential sources, deem their inquiries as "urgent" when submitting them and/or file a formal complaint about how their request was handled;
  4. Respondents also were very dissatisfied with the FDA's response time, saying it was too slow.
  5. Of those who did receive the requested materials, about half were satisfied saying the materials were still relevant and newsworthy upon receipt. This, in some ways, contradicts a follow-up question that asked respondents if they actually used the materials they received. Nearly half didn't end up using the materials requested, and only a quarter said the information obtained resulted in a major news story.


Of the respondents surveyed:

  1. Fax is the most popular way to submit a request with standard mail a close second;
  2. More than 70 percent of respondents took three hours or less to submit a request with the FDA and were disgruntled with the turn-around time for the requested information;
  3. One-third of those surveyed received the information requested within 20 days, while nearly 36 percent received the data within two months. Many respondents report they still have pending requests out.
  4. The lag time caused nearly half of the respondents to say that their story wasn't relevant or newsworthy by the time they received the material from the FDA;
  5. Some respondents indicated that they never received any response from the FDA about their inquiries.

The heart of the problem between reporters making the FOIA requests and the FDA lies in lag time. With the 24-hour news cycle demanding more of journalists, are reporters too demanding of the FDA? Or should they be more demanding? Is the FDA living up to the task with which it is charged under the FOIA?

Close to 70 percent of reporters responding to the survey say they have had a story held or left unpublished because the FDA did not respond in a timely manner. Thus, the data suggests, many are justified in saying they are "very dissatisfied" when it comes to submitting FOIA requests to the FDA, with 44 percent responding as such.

In addition to dissatisfaction at the lack of timeliness of the FDA's responses, nearly half of those surveyed reported the FDA as being somewhat or very unhelpful in their pursuit of information.

Ironically, the bulk of respondents were pleased with the user-friendly nature of the material they eventually received, yet just one out of every four respondents broke a major news story with the information provided.

The vast majority of respondents stated the information they received from the FDA, while user-friendly, was either not used in the story or just briefly mentioned.

Respondents reported more favorable reviews of other agencies that fielded their FOIA requests compared with the FDA.

Nine out of 10 respondents had submitted FOIAs to other agencies with more than 70 percent saying those experiences were significantly or somewhat better than with the FDA.

Yet the ways in which reporters pursue information from the FDA are the most telling of the FOIA experience.

Nearly half of all respondents aren't proactive in pursuing the information from sources other than the FDA.

And when the information was not granted to reporters in a fashion that they deem timely, only a small fraction actually took their grievance up with the FDA by filing a formal complaint.

Also, 70 percent of respondents hadn't labeled their FOIA requests urgent when submitting them to the FDA.

Problems with the data:

Of the 169 respondents, only 44 had filled out a FOIA request to the FDA in the past five years. For a better picture of the FDA's FOIA response procedure and time, we ideally would need to locate more journalists who have filled out a request. We could also expand the question to include journalists who had filled out an FDA FOIA request in the past six or seven years, just to get more respondents.

It is difficult to get a picture of how a government agency works when we only have 44 samples. One of the more significant, but subtle, problems with the data is the abundance of contradictions with the responses. Many respondents said they were satisfied with the materials they received, but few actually used the materials. Many were dissatisfied with the response time, but few filed a complaint.

Also, many said other government agencies do a better job, but on question 21, 21 respondents out of 29 said the FDA was significantly better or somewhat better than other agencies. It may be that FOIA problems are across the board for government agencies and not just the FDA.

What's Next?

Areas to pursue for future research: why are more journalists not filing FOIA requests; why did so many of those who filed requests allow their stories to go held or unpublished? Was there the option of sending another FOIA request?

Some respondents said other government agencies do a better job of fulfilling FOIA requests. Which agencies, and how is it different from what the FDA does? How many FOIA requests does the FDA gets compared to other agencies? Perhaps a major influx of requests contributes to their lack of timeliness. This could be why other agencies are better at responding than the FDA.