How To File A FOIA Request With The FDA

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foia.jpgThe FDA is notoriously slow about responding to Freedom of Information Act requests. So Bloomberg News spent time getting frustrated, but got a story. They found the FDA’s 20,365 unfilled requests last month exceed the tally at the Justice Department and the Defense Department, and the total was up from 19,948 last fall.

Here’s the clinker - nearly 10 percent are three years old. And who has outstanding requests from four years ago? Pfizer sought all inspection reports for a plant in Puerto Rico. Merck requested documents on thimerosal, a preservative containing mercury that is used in vaccines. And Public Citizen asked for info about the dangers of various drugs.

Naturally, the reporter filed a request last November for copies of the longest-pending inquiries. And what happened? The FDA responded in April, but given the info sought, that’s not too bad. The backlog “suggests that maybe we need to put some more resources into”‘ handling the requests for documents, admits Fred Sadler, who heads the FDA office in charge of FOIA requests.

Pharmalot has been filing FOIA requests for a long time and hasn’t had to wait three years very often. So here’s some advice, admittedly from someone with a press pass. Make sure you use language in your request citing the applicable law and carefully explain your reasons for seeking the info. Mail the request. Fax the request. Then, follow up with a phone call, or five. Keep tabs. Ask which office is handling the request. Call them, regularly. Yes, you are now a babysitter. But the FDA can be a difficult child.

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  1. [...] seeking unredacted information from the Agency should take note of Ed Silverman’s “best practices,” which he posted on Pharmalot [...]

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