OpenTrialsFDA works on making clinical trial data from the FDA (the US Food and Drug Administration) more easily accessible and searchable. For every instance in which the FDA has approved a drug for an indication, the FDA will have reviewed the pertinent data on efficacy, safety, etc., and the resulting review documents are incorporated into a drug approval package (DAP). The FDA makes these DAPs available on its [email protected] website, but consistently only for the first approved indication. Unfortunately, DAPs for subsequently approved indications are typically not posted.1,2 For example, aripiprazole’s (brand name Abilify®) DAP is posted for indication #1 (schizophrenia, 2002) but not for later-approved indications (e.g. bipolar mania, 2004 and depression, 2007). Another class of DAP that will not be found on [email protected] are those corresponding to approvals before 1997.1,2 The FDA’s stated reason for this state of affairs is inadequate staffing.
Nevertheless, those DAPs do exist, and the FDA is obliged to make them available via the Freedom of Information Act (FOIA), if not electronically, then in response to a FOI request. In this blog we explain how you can help to get this missing information online.
The OpenTrialsFDA project began with an automated download of all documents posted on [email protected] The download captured not only DAPs, but also letters written by the FDA notifying drug companies that their drug had been approved for a new indication, allowing us to identify drug-indication combinations for which DAPs were absent. A list of these missing-in-action (MIA) DAPs is shown below and on this page.
Our invitation to you
If there is a DAP you do not have but think it should be shared publicly, please check [email protected] and verify that our automated process did not somehow miss it. You may use the procedure in this BMJ article2, though be aware that the FDA recently made slight modifications to the procedure.
Making a FOIA request
Once you have verified that the DAP of interest is indeed not posted on [email protected], please consider making a FOIA request for it. The usual way to place a FOIA request is via the FDA’s FOI website. We invite you to use this template. Your request should contain the following information (part of which can be found in our list above):
- Drug brand name
- Drug generic name
- Indication approved (consider consulting the product labeling to verify that this is an FDA-approved, not an off-label, indication/use)
- Date of approval for that indication, aka “Action Date” (often this information can be obtained via Google, but you we suggest you confirm this by looking at that drug’s approval history on [email protected], where you should find a letter of that date documenting the approval)
- Types of reviews requested (e.g. medical, statistical)
Just be aware that it may take several months, perhaps more than a year, for the FDA to complete the request. A major reason for this delay is (a) the FDA’s FOIA office is chronically short-staffed (as noted above) and (b) they must go through the DAP and identify and redact any information they deem to be “commercial confidential” or “trade secrets”, as they are exempt from disclosure.
Making a FOIA request for previously released information (possible shortcut)
Before making such a FOIA request, we want to make you aware of a possible shortcut—a request for previously released information. That is, perhaps someone else has recently requested the same information and obtained it, in which case the FOIA office has already completed the time-consuming redaction process, which means there is no need for them to do it all over again. Therefore, in this type of FOIA request, you essentially say to the FDA’s FOIA office, “Whatever you gave to that previous requester, I’d like that, too.”
So now you might ask, how do you know whether the DAP you’re after has, in fact, been requested and released? FOIA case logs! A case log lists the completed FOIA requests, who made the request, the information requested (e.g. drug name, review types), and—most importantly—the request number (“control #”).
And how do you get a case log? You make a FOIA request for it! Even easier, feel free to search the one Dr Turner obtained recently, which covers the period January 2012 – September 2016.
This process might well sound circular, but it can save lots of time, because requests for previously released information often get completed within weeks rather than months or longer.
Tracking your contribution
If and when you do make a FOIA request, please let us know by completing this form so that we can keep track of what DAPs have been requested. Please also keep us informed on what the FDA’s response was (usually some variation of “we’ll get to it and send you the information when it’s ready”).
Finally, if you think OpenTrialsFDA is an important contribution to the public health, and if you’d like to support our effort to pry open this vault of priceless clinical trial data, please help us win the Open Science Prize by casting your vote before 6 January 2017. Thank you!
- Turner EH. A taxpayer-funded clinical trials registry and results database. PLoS Med. 2004;1(3):e60. doi:10.1371/journal.pmed.0010060.
- Turner EH. How to access and process FDA drug approval packages for use in research. BMJ. 2013;347(oct14 2):f5992-f5992. doi:10.1136/bmj.f5992.