Release of Complete Response Letters – Industry-FDA Transparency –Is This a Good Idea?

After reading a nice blog post by Kurt Karst and Josephine Torrente on the FDA Law Blog (here) on a push to release Complete Response Letters (CRL), I thought to myself (at first),  now, that would be a good idea to promote transparency to the general public.  Then, I recoiled a bit, and thought, well, there is a lot of confidential commercial, trade secret information that may be contained in those letters.  They would need to be highly redacted and might resemble some of the cartoon-type pictures of a government redacted document with only the date and name of the applicant visible.

Well, we all know that, if the release of CRLs did occur, there would be a great deal of redaction, and that would likely fall on an already overburdened FOI staff or on the Project Managers assigned to the applications.  For the new drug applications (NDAs), we are not talking about lots of letters but certainly if the abbreviated new drug applications (ANDAs) are included, this may be a game changer.  At this time, the FDA site Drugs@FDA hardly posts any approval or tentative approval letters for ANDAs which are releasable, can you imagine getting the effort in getting the CRLs posted?  Besides the redaction and logistics involved, FDA would also have a lot of legal work to do before deciding to post CRLs, because, for years, even the existence of an unapproved NDA or ANDA has been treated as proprietary information with no information publically releasable until such time of tentative or full approval.

So, it seems that there are plenty of hurdles that need to be jumped prior to seeing any release by FDA of CRLs.  I am also sure that the legal departments in many firms are already preparing briefs and position papers and contacting lawyers who specialize in Food and Drug Law to formulate a position one way or the other on this issue.  I remain on the fence on this one!  What do you think?  Please let me hear your comments which can be sent directly to me at r.pollock@lachmanconsultants.com.