Yesterday, I sent the following email to Ms. James, DFO of CFSAC:
Dear Ms. James,
I heard that the CFSAC P2P Working Group had prepared a document for official submission regarding P2P to be discussed at the upcoming CFSAC meeting and that this report was heavily edited by HHS before being sent to the full committee. Is that true? If it is, then I believe the public should see both the original Working Group document prior to HHS’s editing and the document that went to the full committee.
I look forward to your reply.
Ms. James replied as followed:
The draft comments, which will be finalized during tomorrow’s meeting, will be posted to the CFSAC website after the Secretary has signed off on them.
I answered Ms. James with the following email:
Dear Ms. James,
Thank you for your reply. I am afraid, however, that it was not responsive to my question.
So, let me ask again: Was the document that the CFSAC P2P Working Group had prepared as draft comments to be discussed at the CFSAC meeting and, once finalized, to be submitted as official CFSAC P2P comments edited by HHS before being sent to the entire committee? If so, would you please make both versions of the document available.
CFSAC patient representative, Donna Pearson, sent an email to several patients who had asked similar questions, in which she gave her view of the events surrounding the P2P Working Group document and the edits made to that document by HHS. Therefore, I am also requesting that all emails between the Working Group and HHS staff concerning the Working Group document and the HHS edits thereto be made available, so that the public can fully understand what occurred.
I am looking forward to your responsive reply.
Just to clarify, my request includes all emails among the Working Group members on the subject.
The HHS actions regarding potentially heavily editing the Working Group document raise serious concerns with respect to the independence of he committee and the lack of transparency. These and other related actions will be investigated to determine any potential violations of FACA and other federal laws and regulations, including a potential violation of the requirement to make documents to be discussed at the meeting available to the public in advance.
PS: Dr. Susan Levine, Chair of CFSAC, and Donna Pearson, CFSAC’s P2P Working Group Chair, were copied on my correspondence with Ms. James.