Today, I filed a request with Barbara James, DFO of CFSAC, under the Federal Advisory Committee Act (FACA) regarding the January 13, 2015 CFSAC meeting and CFSAC’s P2P comments. My letter, which in addition to requesting immediate access to various documents relating to the meeting and comments, shows that FACA was clearly violated by HHS in connection with the last CFSAC meeting, is reproduced below. My last blog post reproducing correspondence with Ms. James gives context for my request.

The public’s P2P comments were due on January, 16, 2015, three days after the CFSAC meeting. Doesn’t it strike anybody as peculiar that the DFO (and CFSAC) was so confident that the Secretary would sign off on the comments on such short notice? After all, CFSAC recommendations have, for years, largely been ignored by the various Secretaries who either haven’t replied to them at all or taken months or years to do so, typically rejecting them.

HHS has never had ME patients’ best interest at heart and it certainly hasn’t with their recent duplicative IOM and P2P initiatives, which have been cloaked in secrecy; been pushed through with the speed of light; been directly opposite to the October 2012 CFSAC recommendation, the letter of the 50 ME/CFS experts to Secretary Sebelius recommending the adoption of the Canadian Consensus Criteria and the letter of 171 advocates to Secretary Sebelius supporting our experts; been excluding both experts and patients from participation in the IOM and P2P efforts in any meaningful way; been designed as unscientific from the start; been wasting taxpayer money when our disease otherwise hardly receives any and been just absurd. Just as an example, two words: jury model! And yet, the Secretary was expected by the DFO (and the committee) to approve the CFSAC P2P comments on the spot, which is not only unprecedented for this patient population, but must have invoked emergency-type procedures. The fact that HHS is so highly interested in having CFSAC provide official comments to the P2P speaks for itself because HHS has made it very clear throughout the entire P2P process that what’s best for patients is not only at the very bottom of the agency’s list; it didn’t even make the list.

The contrast between usual CFSAC business and the handling of the P2P comments is so stark that it compels the question as to whether CFSAC is merely being used by HHS to legitimize the P2P farce. It is certainly curious that CFSAC’s P2P advice to the Secretary seems to have been heavily influenced—when the committee, by law, is supposed to be independent from the parent agency—by HHS through extensive edits made to the P2P Working Group comments. Talk about circular! Was CFSAC’s advice to HHS’s Secretary basically being orchestrated, in large part, by HHS itself?

Via Email: Barbara.James@hhs.gov

January 17, 2015

Re: Request for Records Relating to January 13, 2015 CFSAC Meeting

Dear Ms. James,

I am a patient advocate for Myalgic Encephalomyelitis. I am writing to request disclosure of documents relating to the January 13, 2015 CFSAC meeting (“Meeting”) pursuant to Section 10(b) of the Federal Advisory Committee Act (“FACA”). This section of FACA provides as follows:

“Subject to section 552 of title 5, United States Code, the records, reports, transcripts, minutes, appendixes, working papers, drafts, studies, agenda, or other documents which were made available to or prepared for or by each advisory committee shall be available for public inspection and copying at a single location in the offices of the advisory committee or the agency to which the advisory committee reports until the advisory committee ceases to exist.” [emphasis added]

I hereby request that all documents falling under Section 10(b) of FACA relating to the Meeting be made available immediately. Without limiting the scope of this request, I particularly request that the proposed comments regarding NIH’s ME/CFS Pathways to Prevention (“P2P”) program prepared by the ad hoc CFSAC P2P Working Group and made available by the Working Group to the entire committee for discussion at the Meeting be provided, along with earlier drafts of the proposed comments by the Working Group, whether or not sent to the entire committee, working papers and revisions of the proposed comments, including, without limitation, those suggested and/or requested in writing or verbally by Ms. James, HHS’s Designated Federal Officer for CFSAC, or other HHS personnel, contractor or representative (collectively, “HHS”), whether or not incorporated into the proposed comments by the CFSAC P2P Working Group provided to the full committee and/or discussed at the Meeting and/or sent to Secretary Burwell (collectively, the “Proposed Comments”). My request includes all emails and other correspondence between and/or among CFSAC members (voting members, ex officio members liaison representatives, and/or P2P Working Group members, collectively, “CFSAC members”)), the DFO or HHS relating to the Proposed Comments and the Meeting. I am also requesting all emails from and to patients, advocates and other stakeholders sent to or by Ms. James, HHS or any CFSAC Member requesting or otherwise regarding the Proposed Comments and/or regarding the Meeting.

Please note that government agencies may not require members of the public or other interested parties to file FOIA requests for non-exempt advisory-committee records. (41 C.F.R. §102-3.170). Although records covered by FOIA exemptions may generally be withheld, please note that, in accordance with the Memorandum for Committee Management Officers from James L. Dean, Director, Committee Management Secretariat, dated March 14, 2000 (“Memorandum”), “FOIA Exemption 5 cannot be used to withhold documents reflecting an advisory committee’s internal deliberations” (see also Preamble to final rule under 41 C.F.R. Parts101-6 and 102-3, Federal Register, Vol. 66, No. 139, p. 37731 (July 19, 2001); opinion of the Office of Legal Counsel, U.S. Department of Justice, 12 Op. O.L.C. 73, April 29, 1988, entitled “Disclosure of Advisory Committee Deliberative Materials.”). [emphasis added] Further, as noted in Food Chemical News v. Department of Health and Human Services, 980 F.2^nd 1468 (D.C. Cir. 1992), the Court of Appeals for the D.C. Circuit held that:

“… under section 10(b) of FACA an agency is generally obligated to make available for public inspection and copying all materials that were made available to or prepared for or by an advisory committee. Except with respect to those materials that the agency reasonably claims to be exempt from disclosure pursuant to FOIA, a member of the public need not request disclosure in order for FACA 10(b) materials to be made available. Thus, whenever practicable, all 10(b) materials must be available for public inspection and copying before or on the date of the advisory committee meeting to which they apply.” [emphasis added]

Accordingly, pursuant to the Memorandum, “… agencies may not delay making available non-exempt records to interested parties under FOIA procedures as an administrative convenience, or for other reasons.” The Memorandum further states that “[g]iven the plain and unambiguous language contained in section 10(b) of FACA, coupled with controlling case law and DOJ’s FOIA guidance, [the Director, Committee Management Secretariat is] encouraging each Committee Management Officer (CMO) to assure the maximum timely availability of covered advisory committee records.”

To the best of my knowledge, none of the materials requested above, not even the version of the Proposed Comments discussed at the Meeting, were made available to the public before, or on the date of, the meeting in direct violation of FACA section 10(b) and, to my knowledge, have still not been made available. This calls into question whether the Meeting itself qualified as a public meeting since the public was denied access to the key document and background material considered at the Meeting, preventing the required “meaningful opportunity for the public to fully comprehend the work undertaken by the committee.” (see 41 C.F.R. §102-3.170)

The requested documents, once received, will be published on my blog, “Thoughts about M.E.,” to allow the public a full understanding of the circumstances surrounding the Proposed Comments.

This is my third written request with respect to some of the requested material.

Please respond immediately to advise me as to when you will provide me with access to the requested documents. Otherwise, I will promptly pursue legal avenues to enforce FACA compliance.

Sincerely,

Jeannette K. Burmeister

(Attorney at Law)

Attachment:

Memorandum for Committee Management Officers from James L. Dean, Director, Committee Management Secretariat, dated March 14, 2000

Cc:

Sylvia Burwell, Secretary for Health and Human Services (Sylvia.Burwell@hhs.gov)

William B. Schultz, General Counsel of HHS (William.Schultz@hhs.gov)

Director, Committee Management Secretariat, General Services Administration (cms@gsa.gov)

Olga Nelson, Committee Management Officer, Office of the Assistant Secretary for Health, Department of Health and Human Services (olga.nelson@hhs.gov)

CFSAC Voting Members (via CFSAC mailbox: cfsac@hhs.gov):

Susan Levine, M.D. Chair

Adrian M. Casillas, M.D.

Rebecca Patterson Collier, R.N., CCM

Dane B. Cook, Ph.D.

Lisa W. Corbin, M.D.

Mary Ann Fletcher, Ph.D.

Gary E. Kaplan, D.O.

Alisa E. Koch, M.D.

Jose G. Montoya, M.D.

Faith Newton, Ed.D

Donna M. Pearson

CFSAC Ex Offiicio Members:

Jennifer E. Moore, Ph.D., R.N., AHRQ (jennifer.moore@ahrq.hhs.gov)

Ermias Belay, M.D., CDC (eeb8@cdc.gov)

Elizabeth Unger, M.D., Ph.D., CDC (eunger@cdc.gov)

Alaine Perry, M.P.H., CMS (Alaine.Perry@cms.hhs.gov)

Janet W. Maynard, M.D., FDA (janet.maynard@fda.hhs.gov)

Keith Hull, M.D., Ph.D., FDA (keith.hull@fda.hhs.gov)

Deborah Willis-Fillinger, M.D., HRSA (dwillis-fillinger@hrsa.gov)

Mariela C. Shirley, Ph.D., NIH (Shirleym@od.nih.gov)

Susan E. Maier, Ph.D., NIH (Susan Maier maiers@od.nih.gov)

Cheryl A. Williams, SSA (Cheryl.Williams@ssa.gov)

Amanda Wulf, SSA (Amanda.wulf@ssa.gov)

Bcc:

Susan Levine, M.D.

Charmian Proskauer

Claudia Goodell (to be sent once email address obtained)