Interpret this as you will: III. OPEN GOVERNM

III. OPEN GOVERNMENT STATUTES

Generally, the FDA's approach to data disclosure has been that no public disclosure of information will take place until (and unless) a drug is approved. [13] Indeed, the agency will not even acknowledge that an IND or an NDA has been filed, although companies filing with the Securities and Exchange Commission report such information and often ensure that positive findings from their studies receive media coverage. For those drugs that are evaluated by FDA advisory committees, there is an additional, brief window in which the NDA is formally acknowledged and the data supporting the application are disclosed.

The two statutes that have provided the greatest access to pharmaceutical data are the Federal Advisory Committee Act (FACA) 14 and the Freedom of Information Act (FOIA). [15] FACA ensures that advisory committees are subject to transparency requirements such as advance notice of upcoming meetings, opportunities for public attendance and input, and the preparation of transcripts. [16] FOIA requires public disclosure, upon request by any individual, of agency documents that do not fall into one of nine specific exemptions from disclosure. [17]

In 2004, the FDA processed a total of 18,540 FOIA requests at a cost of $12.8 million. [18] By permitting the online posting of certain frequently requested documents, the Internet has eased the agency's workload somewhat. But the backlog has nevertheless continued to grow and stood at 16,671 pending requests at the end of 2004.

The agency processes requests in two tracks: simple and complex. The latter category applies to requests seeking a voluminous number of records or records from which the agency will want to redact information that falls under one of the FOIA exemptions. For 2004, the agency reported that eighty-nine percent of the requests it received were simple and usually processed in a median of twenty-five days. Eleven percent were considered complex and were processed in a median of 325 days. In no instance did the FDA expedite processing in response to a requester's assertion of "an exceptional need or urgency," [19] the standard for expediting.

BMSN!