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FOI

FOIA & the FDA: Interviews with journalists

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Related

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.

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

Handbook for requesting information and records from FDA

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FDA Press Office contacts

FDA's regional public affairs specialists

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FDA's Freedom of Information Annual Report - FY 2007

Preliminary Interviews:

Before creating the survey, we interviewed six randomly selected journalists whose names appeared on our 2006 list of FOIA submitters. Two of them did not want their comments to appear publicly in this report. The following are transcribed notes from the other interviews.

Kristin Jensen/Bloomberg: Jensen hasn't made a FOIA request to the FDA in about eight or nine years. She has generally found the FDA to be not particularly responsive and didn't FOIA them often because didn't think they were that helpful. She would have done it more if they had been more helpful. The FDA has at least three big divisions that Bloomberg has FOIA'd; each acted like different agencies. The divisions were: CDER - Center for Drug Evaluation and Research; CDRH - Center for Devices and Radiological Health; and CBER - Center for Biologics Evaluation and Research. They had very different response times, and unique procedures. The longest time Bloomberg has had to wait for a response made following a FOIA request was probably 1.5 years, in the mid 1990s. That was the drug division. The FDA has a lot of proprietary information that they can't share, so that's an issue with FOIAs - I assume that's different than other agencies. Once Bloomberg received the information requested-oftentimes, way past story deadlines, it consisted of pages and pages of useless information. Jensen has never held a story based on waiting for a response from the FDA after having made a FOIA request. If they submitted a FOIA request to the FDA, it was for stories down the road.

Dawn Fallik/The Philadelphia Inquirer (formerly): Fallik thinks the basic problem is that the FDA doesn't have enough people to handle the requests, and that they don't understand data requests. She wrote one story about heat and patch medications, and, for the story did an analysis of the drug reaction database, and found a slew of incidents where heat had played a problem. She learned the FDA was doing a study just on heat and patch medication and wanted to ask them about it. She put in the request as soon as she started doing the story, sent it in 3 or 4 times, and they never got back to her. She would call, email, and still received no response. She advised them that the story was slated for publication; they acknowledged that, and agreed to send the requested information [on a Monday], if she held her story for one week. They never got back to her, even after her additional phone calls and emails to them. Fallik has also FOIA'd the FDA before the aforementioned incident-they never responded quickly, but they did respond to other requests. It seemed, said Fallik, to be the most controversial topics that they kept blowing her off on. She had to nag them or call them many, many, times. Other agencies Fallik FOIA'd were quite responsive: The CDC and DOT, for example, would generally respond in a timely fashion. The FDA has probably been the most challenging.

Ron Nixon/The New York Times: It took Nixon several months to receive most requests. He has filed about six in total with the FDA. Nixon expressed disappointment due to lag time and the FDA staff's seeming inability or unwillingness to provide the information we wanted.

Christine Cox/The South Bend Tribune: Cox doesn't think the FDA ever responded to her request. If she doesn't give them the 20 days, they don't get back to her. She recalled not having had a lot of turnaround time on the story, which was about giving your kid Benadryl to knock them out during traveling. In general, her complains are that the FDA doesn't respond with information quickly enough for her needs, and that their website is impossible to navigate. Though Cox doesn't remember the last time she FOIA'd the FDA, she frequently FOIAs different agencies.

Post-Survey Interviews:

The following are transcripts of sample follow-up conversations we had with journalists who responded to our survey. Comments made by journalists who spoke with us off the record will not appear below.

Steve Chamraz/KMOV-St. Louis: Chamraz made a FOIA request to the FDA on March 27, 2006 and received a response on April 6, 2006. The information he requested was FedExed to him. The materials he received were incomplete, but he said, he still had a lot to work with. Chamraz is researching a story on a specific company, but is still holding the story. About one month after the FDA's initial response, the agency sent a letter saying it had completed the reporter's request. The FDA denied access to some materials, citing proprietary information. Chamraz appealed the decision on June 20, 2006, at which time the FDA came back with all the requested information. In total, it took 3.5 months for Chamraz to receive all materials he had requested, a time period, he said is far, considering the review and appeal he had to go through. "I was pretty specific... I was referring to recalls of specific materials. I had specific case numbers. It was a very narrow focus," Chamraz told us. "Whenever I write a records request, I make it as specific as possible. Talk to people In advance to know what to ask for to get the information as quickly as possible." Chamraz also talked to us about a request to FEMA that has been "hanging out there" for more than a year, perhaps up to a year and a half now.

Annys Shin/The Washington Post: Shin said the FDA is generally good about responding that they actually received the query. She sent one last fall, but has heard nothing back. A lot of her reporting centers around food recalls, and she likes to use inspection reports for her stories. She said that by the time the information gets to her, the story is old news. She does keep the information on file, just in case its needed later. In another instance that she described to us, the information took three months to arrive. Shin sometimes turns to the Food & Water Watch, an organization that FOIAs the FDA before the mainstream media may need it.