Documents Related to the User Acceptance Testing of Tafenoquine

To Whom It May Concern:

Pursuant to the Freedom of Information Act, I hereby request the following records:

Documents, including research protocols, data collection instruments, collected data (including user compliance and user feedback data, and general user comments), reports, presentations, and correspondence, related to USAMRMC's user acceptance testing of tafenoquine, as described in USAMRMC contract W81XWH19C0181, which specifies that "The goal of this testing is to gain information regarding user compliance of a weekly dosing schedule versus a daily schedule; the suitability of packaging; its ability to be used in multiple operational environments; and a single dose post deployment instead of the current standard of care (SOC) 14 day treatment course. The operational testing will look at the drug‘s performance attributes and usability. User feedback will evaluate U.S. Service Members’ preference for a weekly medication, positive or negative side effects compared to the current standard of care prophylactic malaria medications, and general comments on ease of use of the packaging."

The requested documents will be made available to the general public, and this request is not being made for commercial purposes.

In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.

Sincerely,

Dr. Remington Nevin

Dear USAMRDC FOIA Staff,

Please provide an update on the status of FOIA request FA-20-0033, dated February 21, 2020, which requested "[d]ocuments, including research protocols, data collection instruments, collected data (including user compliance and user feedback data, and general user comments), reports, presentations, and correspondence, related to USAMRMC's user acceptance testing of tafenoquine."

I note that the per the enclosed document, the tafenoquine tablets obtained under contract W81XWH-19-C-0181 for this testing, are to expire in November 2020, suggesting this testing should be nearing completion and thus many documents responsive to the request should be available.

I thank you in advance for your assistance.

Sincerely,

Dr. Remington Nevin

August 20, 2020

FOIA APPEAL
General Counsel
U.S. Army Medical Research and Development Command
Attention: FCMR-AAZ-A
820 Chandler Street
Fort Detrick, MD 21702-5014

Re: FOIA Request FA-20-0033

Dear General Counsel,

This is an appeal pursuant to the Freedom of Information Act (FOIA), concerning the U.S. Army Medical Research and Development Command's ("USAMRDC") refusal to disclose certain documents within its control in response to a FOIA request.

USAMRMC's refusal to disclose the requested items violates the FOIA, and by this letter I am making a timely appeal pursuant to the FOIA in response to the Agency's denial of the FOIA request, as described in USAMRDC's correspondence dated July 20, 2020 (the "denial letter”), which was inexplicably sent by email on August 19, 2020, and received on this date, nearly a month after it was dated.

As a brief summary of the history of this request, on February 21, 2020, I submitted a request to USAMRDC under the FOIA for all documents related to USAMRDC’s user acceptance testing of tafenoquine. On July 20, 2020, not having received a response, I requested an update on the status of my request, noting that the tablets of tafenoquine obtained under contract W81XWH-19-C-0181 specifically for this testing, were to expire in November 2020, suggesting this testing should be nearing completion, and thus that many documents responsive to the request should be available.

In correspondence described above dated July 20, 2020, but again not sent until August 19, 2020, Mr. Christopher Sherman, USAMRDC Initial Denial Authority, denied my request in full, claiming a FOIA exemption as per 5 U.S.C. § 552(b)(5) (hereafter referred to as the FOIA “(b)(5)”, or the “draft status” exemption) for release of responsive records including User Assessment Study documentation, Research Protocol Study Design documentation, Data Collection Instruments, Reports, and Presentations.

This correspondence conceded that no data had thus far been collected for the study, suggesting that the study had not yet begun, despite only three months remaining prior to the expiration of the 7,500 "packages" (or boxes of 16 tablets each) of Arakoda®-branded tafenoquine, obtained for a total award amount of $2,137,500 under CLINs 0001 and 0002, from vendor 60 Degrees Pharmaceuticals (60P), via sole-source contract W81XWH-19-C-0181.

In addition to claiming the draft status exemption, this correspondence also claimed that all of the responsive documents listed above were also exempt from disclosure under 32 CFR 518.32 as they are deliberative and pre-decisional documents.

The withholding of all documents related to this request cannot be permitted under the (b)(5) exemption, nor under 32 CFR 518.32, and all documents related to this request cannot be considered “pre-decisional” or “deliberative”, for the simple reason that USAMRDC’s purchase of $2,137,500 of tafenoquine for the expressed purposes of enabling the proposed study, by its nature constitutes a final decision informing a contract scope of work, and therefore subject to public disclosure under the FOIA.

While USAMRDC may argue that certain specific subject-facing study documents may be subject to withholding for the reasons outlined, documents which provide justification for the decision to purchase the specific quantity of this medication, namely 7,500 "packages" (or boxes of 16 tablets each) of Arakoda®-branded tafenoquine, for the amount of $2,137,500, are by definition final, as these were used by USAMRDC to inform specific contracting decisions and, ultimately, federal spending.

To argue that no final, non-draft and non-predecisional documents are available related to this request would be for USAMDRC to concede that it purchased this specific quantity of medication without any rationale, and without any prior planning. However, such a concession would be inconsistent with the stated purpose for the awarded contract, which states:

“The USAMMDA PMO requires Tafenoquine brand name Arakoda in order to accomplish User Acceptance (Initial Operational) Testing for the malaria prophylactic drug (Tafenoquine). The goal of this testing is to gain information regarding user compliance of a weekly dosing schedule versus a daily schedule; the suitability of packaging; its ability to be used in multiple operational environments; and a single dose post deployment instead of the current standard of care (SOC) 14 day treatment course. The operational testing will look at the drug‘s performance attributes and usability. User feedback will evaluate U.S. Service Members’ preference for a weekly medication, positive or negative side effects compared to the current standard of care prophylactic malaria medications, and general comments on ease of use of the packaging .”

The language of this paragraph does not allude to predecisional or draft plans, but to final decisions, using the active verb “will” to describe actions that were already decided upon by USAMRDC at the time of publication of the contract solicitation. Consequently, all documents, including correspondence and presentations related to the development of this contract scope of work would clearly fall within those documents responsive to my request.

Simply put, it is unreasonable at face value for USAMRDC to argue that there are no responsive documents which describe the specific rationale for the completed purchase of 7,500 “packages” of this medication, rather than 1,000; 10,000; or some other number, for to claim as much would beb to concede that USAMRDC purchased an arbitrary quantity of this drug, at considerable expense, under a sole source contract, without any underlying rationale.

As these responsive documents are not draft or predecisional, and thus not subject to either claimed exemption, the FOIA consequently requires that these records be produced within 20 business days of the date of the request.

I thank you for your attention to this request and look forward to release of the requested information within the timeframe provided by the law. Please don't hesitate to contact me should you have questions concerning this appeal.

Sincerely,

Dr. Remington Nevin

Dear Ms Gaynor,

Thank you for your message dated November 16, 2020, sent presumably in response to my appeal dated August 20, 2020, related to FOIA request FA-20-033, which I originally sent February 21, 2020, and which addressed the contents of the file "IDA Letter FP-20-014315 July 21 20 Response," accompanying your message.

In your message, you note the presence of "confusion." If there is any confusion, it is on the part of USAMRMC in failing to provide the responsive records, as provided by the FOIA, and in failing to adjudicate my appeal in a timely manner, as required by statute.

As outlined in my appeal, the responsive records which USAMRMC acknowledges exist, but have denied release on the grounds of the (b)(5) exemption and 32 CFR 518.3, are not subject to these exemptions.

If you have not yet forwarded my appeal to the appropriate General Counsel for review as the statute requires, please do so at your earliest opportunity, and acknowledge this action.

I thank you for your attention to this important matter.

Sincerely,

Dr. Remington Nevin