Obtaining certain information from the FDA can be a challenging exercise, regardless of your station in life. Often enough, a Freedom of Information Act request must be filed, but even when material is returned, the documents can be filled with deletions. There are myriad reasons cited, such as company trade secrets. But in other words, not all of the sought-after information can be read.
However, one consumer watchdog argues the agency is violating the Freedom of Information Act because the agency purportedly redacts some information in documents without giving those who requested the material an "immediate" right to appeal. The FDA, by the way, calls this a 'minor deletion' policy, although a minor redaction is, most likely, in the eye of the beholder - or in this case, the requester.
And so, Public Citizen has petitioned the agency to end its policy, arguing that minor deletions "are not formal denials of information requests and, therefore, do not trigger a requester’s immediate right to appeal. The agency instead requires requesters to make a second request for reconsideration of any deletions before being allowed to appeal." If this is not done, the FDA closes the FOIA request without ever making a final determination (here is the petition).
"Forcing requesters to make two attempts just to get a proper response to a FOIA request is at odds with the streamlined FOIA process required by Congress,” says Public Citizen Julie Murray in a statement. "Although the agency contends that the policy helps speed the processing of FOIA requests, there is seemingly no reason why it would take any longer for the agency to formally deny a request in part and give requesters the immediate ability to appeal, as other agencies already do. The agency’s current policy is contrary to law, unnecessary to serve FOIA requesters, and ultimately does a disservice to FOIA’s commitment to transparency.”
Meanwhile, the FDA maintains in its Staff Manuals that minor deletions are not formal denials "in the first instance" (see page 12). The agency then maintains that the "overwhelming majority of requesters who receive documents with minor deletions are satisfied with the material they receive and do not request the withheld material." Maybe. But the FOIA process can often take a long time, and tussling with the FDA FOIA office for additional info can be, well, frustrating. This may explain why the FDA believes most people are satisfied. We have a hunch that may not be so.






2 Comments
FOIA requests are maddeningly slow. Much of the information, such as original clinical trial data, should be demanded as the price to entry for all prescription drugs. Then, perhaps, and only then, would the truth be known.
Until then, the buyer really must beware.