Do do do do….do do do do don’t leak this… this may sound like a line from the MC Hammer 1990 music hit U Can’t Touch This.
But it is actually the theme of an internal Food and Drug Administration (FDA) memorandum sent to all employees and you guessed, the memorandum was leaked to the press. (That lasted about mmmm… 20 seconds or just enough time to press the forward button.)
The FDA cited several very legitimate reasons for not sharing e-mails and other information with the world including:
· Trade Secrets
· Confidential Commercial Information (CCI)
· Personal Privacy Information
· Law Enforcement Records and Information
But, they added a new one to the list that seems to be a catch all: Privileged Intra-Agency and Inter-agency documents. This covers everything, including e-mails, letters to and from employees within the FDA.
I believe there is some reasonableness to all of this, who wants their comments or drafts of a letter shared with the world. We all have said dumb things in e-mails and drafts of documents that, after they have been pointed out, make perfect sense. If you read this column enough you probably understand.
There is a need for transparency, but the internal workings are not exactly something that has to become transparent, especially when you are fixing someone’s writing.
We saw that just last week, when according to leaked memoranda, the FDA bent over backwards to accommodate RenGen, a small medical device company, despite serious reservations from one of their reviewers (according to The Wall Street Journal, the FDA was pushed by members of Congress to approve the RenGen device, which now has Senator Grassley investigating the FDA for allowing themselves to be pushed by members of Congress) what a vicious cycle.
There is certain information that government agencies should make available to public and is not. For instance, just today, I requested some transcripts from an Institute of Medicine (IOM) open public session which they recorded and got the “sorry, but we can’t help you” response. Also, I asked about some grants that the IOM received and was told they do not have any online reporting of their grants and have no plans to publish them.
The government is calling for greater transparency from everyone else, perhaps it is time they had some of their own.
The Wall Street Journal Blog and Invivo Blog both have more information on the memorandum, enjoy….
Press
The Wall Street Journal Blog: Grassley Says Knee Device Maker Was ‘Calling the Shots’ at FDA Memo to FDA Staff: Don’t Leak This
The Wall Street Journal: Political Lobbying Drove FDA Process
InVivo Blog: FDA Commissioner to Employees: Keep Quite or Else
FDA
Memorandum from Frank Torti, M.D., Acting Commissioner on protecting confidential information (March 13, 2009)
Memorandum from FDA Review Team Leader, John S. Goode, detailing why he opposed approving the RenGen device (Aug. 14, 2008 )
FDA lawyers' memoranda about language that might "document special treatment" for RenGen (Nov. 3, 2008)
Senator Grassley: Letter to FDA and RenGen