Records Related to the 2019 Army Purchase of Tafenoquine (Arakoda™)

Dr. Remington Nevin filed this request with the U.S. Army Medical Research and Materiel Command of the United States of America.
Tracking #

FP-20-008014

Est. Completion None
Status
Partially Completed

Communications

From: Dr. Remington Nevin

To Whom It May Concern:

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

All records, including purchase records, billing, and shipping information, and associated correspondence, related to the 2019 purchase by the U.S. Army of a supply of tafenoquine (Arakoda™). As noted in a recent press release (https://www.prnewswire.com/news-releases/arakoda-tafenoquine-tablets-first-prescription-drug-approved-for-malaria-prevention-by-us-fda-in-over-18-years-now-available-in-us-300962690.html), the "first significant shipment of Arakoda occurred in September, 2019 to the U.S. Army".

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

From: U.S. Army Medical Research and Materiel Command

From: Dr. Remington Nevin

To Whom It May Concern:

I recently received an unreadable response dated December 6, 2019, related to my FOIA request dated November 22, 2019, for "All records, including purchase records, billing, and shipping information, and associated correspondence, related to the 2019 purchase by the U.S. Army of a supply of tafenoquine (Arakoda™)".

This may have occurred if an email message was sent using encryption.

Could you please resend your response dated December 6, 2019, ensuring that this is sent as a plain text email?

Sincerely,

Dr. Remington Nevin

From: U.S. Army Medical Research and Materiel Command

Resending from Friday.

Thank you

Nancy Gaynor

Good afternoon

The U.S. Army Medical Research Acquisition Activity has received your FOIA
request for records regarding the 2019 purchase by the U.S. Army of a supply
of Tafenoquine (Arakoda).

The purchase of Tafenoquine was accomplished under Contract Number
W81XWH-19-C-0181.

You have indicated in your request below that you are seeking all records. In
order to facilitate a timely response, I would like to obtain clarification
regarding the specific records you are seeking.

It is my understanding that you would like to obtain the follow:

Copy of Contract Number W81XWH-19-C-0181 which is the official purchase record.

Billing Records - Government billing is done so using the Wide Area Workflow
(WAWF) system. I am working with our contracting personnel and legal
department in order to determine the records that can be pulled for release.

Shipping Information - Again I am working with our personnel to determine if
there are any responsive agency records.

Please confirm my understanding of the scope of your request as defined above
is correct, or advise if there any other additional specific records that you
are seeking.

If you have any questions, please contact me to discuss.

Thank you

Nancy Gaynor
Freedom of Information Act Officer
USAMRAA
301-619-2389

From: Dr. Remington Nevin

Nancy Gaynor
Freedom of Information Act Officer
USAMRAA

Dear Ms. Gaynor,

Thank you very much for your response. The materials you describe related to the purchase, billing, and shipping, I would consider responsive to my request. In addition to these, as per my request, please also search for any associated correspondence, such as emails, related to these, as it would appear probable that there would be a significant volume of correspondence created in arranging for the contracted purchase of this drug.

I do appreciate your attention to this matter.

Sincerely,

Dr. Remington Nevin

From: U.S. Army Medical Research and Materiel Command

Good afternoon

I apologize for the delay. The U.S. Army Medical Research Acquisition Activity and the U.S. Army Medical Development Command are in the process of compiling and reviewing records responsive to your request. You will be receiving an interim response later today that will provide you with a FOIA case number.

If you have any questions, please do not hesitate to contact our office.

Thank you

Nancy Gaynor
Freedom of Information Act Officer
USAMRAA
301-619-2389

From: U.S. Army Medical Research and Materiel Command

Good afternoon

Attached is an interim response regarding your FOIA request for records regarding Contract Number W81XWH-19-C-0181. If you have any questions, please contact me to discuss.

Thank you

Nancy Gaynor
Freedom of Information Act Officer
USAMRAA

From: U.S. Army Medical Research and Materiel Command

Good morning

I have a partial response in for legal review. I have emailed the legal office this morning for a status.

I will let you know estimated response date when I hear back from legal.

Thank you

Nancy Gaynor
Freedom of Information Act Officer
USAMRAA

From: Dr. Remington Nevin

Thank you very much for the update on the status of this request.

Sincerely,

Dr. Remington Nevin

From: U.S. Army Medical Research and Materiel Command

Good afternoon

Attached is a partial response to your Freedom of Information Act request. If you have any questions, please contact me to discuss.

Thank you

Nancy Gaynor
Freedom of Information Act Officer
USAMRAA

From: Dr. Remington Nevin

February 20, 2020

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

Re: FOIA Request FP-20-008014

Dear General Counsel,

This is an appeal pursuant to the Freedom of Information Act (FOIA), concerning the U.S. Army Medical Research and Materiel Command's ("USAMRMC") 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 partial denial of the FOIA request, as described in USAMRMC correspondence of February 12, 2020 (the "denial letter").

On November 22, 2019, I submitted a request to USAMRMC under the FOIA for all records, including purchase records, billing, and shipping information, and associated correspondence, related to the 2019 purchase by the U.S. Army of a supply of tafenoquine (Arakoda™), a new antimalarial drug which is pending initial operational testing among U.S. service members.

On December 9, 2019, Ms. Nancy Gaynor or USAMRMC responded to my request inquiring as to whether Contract Number W81XWH-19-C-0181, described as the official record of this purchase, and associated billing records and shipping records would be responsive to my request. On December 9, 2019, I confirmed in a reply to Ms. Gaynor that these materials, together with any associated correspondence, would be responsive to my request.

On February 12, 2020, Mr. Brian Martin, USAMRMC Initial Denial Authority, provided a partial response to my request, consisting of a redacted copy of Contract Number W81XWH-19-C-0181, which describes a contract between USAMRMC and the listed contractor 60 Degrees Pharmaceuticals, in the total amount of $2,137,500, wherein significant portions were redacted under a claimed FOIA exemption as per 5 U.S.C. § 552(b)(4) (hereafter referred to as the FOIA "(b)(4)", or the "trade secrets" exemption), including shipping addresses, shipping instructions, and quantities of drug, unit prices, and total amounts, as listed in the original document primarily by contract item line number ("CLIN").

In its denial letter, Mr. Martin noted that these redactions were made "to protect trade secrets and commercial or financial information obtained from a person emphasis added that is privileged or confidential." Mr. Martin also claimed that the information being protected "is current and if released could compromise the submitter's profit margin on the contract price, labor rates, or staffing and subcontractors."

Few if any of these redactions are permitted under the (b)(4) exemption, for the following reasons:

First, the redacted shipping addresses and shipping instructions serve to keep confidential as "trade secrets" what are presumably U.S. government shipping addresses and instructions. Given that the purpose of the contract, as stated in the document itself, is to accomplish initial operational testing among U.S. service members, it stands to reason that the contract would specify shipping addresses and instructions that would serve to make the drug available to U.S. service members for such testing. Only if the details of such testing among U.S. service members, as could be revealed by such shipping addresses and shipping instructions, are considered "trade secrets and commercial or financial information" by the contractor, 60 Degrees Pharmaceuticals, that are "privileged or confidential", could this information be withheld under the FOIA. By claiming the (b)(4) exemption for this information, the USAMRMC is essentially claiming that revealing the U.S. government shipping location and shipping addresses would harm the contractor. Such a claim appears baseless and difficult to justify at face value.

Second, the redacted quantities of drug, unit prices, and total amounts can be reasonably inferred from the contract details and therefore cannot reasonably constitute "trade secrets". For example, the contract scope of work clearly specifies the initial intended procurement under CLINs 0001 and 0002 of one lot of approximately 120,000 tablets, or 7,500 "packages" or boxes of the drug. These "packages" presumably consist of 16 tablets per box, consistent with descriptions of the drug as being packaged in boxes consisting of two sleeves of 8 tablets per sleeve. The contract scope of work also clearly specifies three optional acquisitions of 3,750 "packages" per CLIN under CLINs 1001, 2001, and 3001. Therefore, the contract itself clearly indicates that each CLIN shall consist of 3750 packages, thus negating any alleged confidentiality precluding the release under (b)(4) of the redacted quantity listed under each CLIN.

However, given that the redacted document clearly indicates non-zero award amounts under each of the CLINs 0001, 0002, 1001, 2001, and 3001, it stands to reason that the contract award included all three options, and therefore that the total contract award of $2,137,500 may have been for as much as 18,750 "packages", or 300,000 tablets total, as per the statement of need. This would indicate the minimum cost per package was approximately $114, or approximately $7.12 per tablet. If the optional CLINs were not not fully exercised, this would indicate the maximum cost per package under the initial CLINs totaling 7,500 "packages" would be $285, or approximately $17.81 per tablet. In other words, it can be reasonably inferred that the cost of a "package" of 16 tablets was somewhere between $114 and $285.

Third, it cannot be reasonably argued based on the stated position of USAMRMC that the redacted unit prices and total amounts, whose ranges can be clearly inferred from publicly-available information as above, could be considered to risk compromising the "profit margin" of the contractor, 60 Degrees Pharmaceuticals, as claimed by USAMRMC in its denial letter. Such a claim would only have merit if release of the unit pricing could be reasonably expected to affect the marketability of the drug. However, tafenoquine for prevention of malaria (marketed by the contractor as Arakoda™) is under patent protection and has no generic competition (see, for example: https://60degreespharma.com/wp-content/uploads/2019/12/60P-PR-Release_Arakoda_Shipping_18Nov2019.pdf), and no other drugs are available that share tafenoquine's unique indication for worldwide prevention of malaria with weekly dosing. For drugs with truly unique indications, for which no acceptable substitutes are available, the market (including the U.S. military market) would be expected bear the full cost of the drug, regardless of economic considerations. In this respect, the USAMRMC's claim that release of unit cost information could compromise the "profit margin" of the contractor implies that either USAMRMC or the contractor, 60 Degrees Pharmaceuticals, believe that acceptable substitutes to Arakoda™ are available on the market, and that economic considerations, such as cost of the drug, may indeed affect the drug's marketability and commercial viability as an antimalarial . However, such an argument seemingly contradicts USAMRMC claims that Arakoda™ is an essential new drug for which no substitutes are available, including that the drug "fulfills an unmet military need" (see https://www.army.mil/article/212996/usammda_celebrates_fda_approval_of_antimalarial_drug_tafenoquine). If the drug truly does fulfill an "unmet military need", then no risk to the contractor can exist from release of the redacted unit prices and total amounts claimed as "trade secrets".

Lastly, the partial response provided by Mr. Martin of USAMRMC also did not include any previously-described billing or shipping records, nor did it include any associated correspondence. I consider the non-inclusion of these responsive records as constructive denial subject to appeal. Although the partial denial letter by Mr. Martin noted that "[a]dditional responsive records will be provided… as they become available", no explanation has been provided by USAMRMC for the delay in providing such records, nor has USAMRMC claimed that there are unusual circumstances that limit their responding to the request. 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

From: U.S. Army Medical Research and Materiel Command

Good afternoon

Attached is an acknowledgement to your FOIA Appeal regarding Case
#FP-20-008014.

If you have any questions regarding the appeal of the records already
received, please refer to the point of contact at OGC as indicated in the
acknowledgement letter. For any questions regarding the remaining records
being processed by USAMRAA, please contact me.

Thank you

Nancy Gaynor
Freedom of Information Act Officer
USAMRAA

From: U.S. Army Medical Research and Materiel Command

A letter stating that the request appeal has been received and is being processed.

From: U.S. Army Medical Research and Materiel Command

Good morning

Attached please find a partial response to your initial FOIA request, Case
#FP-20-008014.

If you have any questions, please contact me to discuss.

Thank you

Nancy Gaynor
Freedom of Information Act Officer
USAMRAA

  • 05W81XWH-19-R-0061 Solicitation Questions RAA Reda..._Redacted APPLIED

  • 04 (RFP) W81XWH-19-R-0061 RAA Redacted Question_Redacted APPLIED

  • 02 [Non-DoD Source] Exclusivity RAA Redacted_Redacted APPLIED

  • 07 FW_ Request for Proposal (RFP) W81XWH-19-R-0061 RAA Redacted_Redacted APPLIED

  • 06 W81XWH-19-R-0052 w attach RAA Redacted APPLIED

  • 03 [Non-DoD Source] Re_ Exclusivity RAA Redacted_Redacted APPLIED

  • IDA Letter, FP-20-008014 second response

  • 09 RE_ Exclusivity RAA Redacted_Redacted APPLIED

  • 08 W81XWH-19-R-0061 Solicitation Questions RAA ..._Redacted APPLIED

  • 01 [Non-DoD Source] Exclusive Manufacturing Rights RAA Redacted_Redacted APPLIED

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From: U.S. Army Medical Research and Materiel Command

Good afternoon

Attached are additional records associated with your FOIA request.

If you have any questions, please contact me to discuss.

Thank you

Nancy Gaynor
Freedom of Information Act Officer
USAMRAA

From: Dr. Remington Nevin

July 20, 2020

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

Re: FOIA Request FP-20-008014

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. USAMRDC’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 most recent partial denial of the FOIA request, as described in USAMRDC correspondence of July 14, 2020 (the “denial letter"), which is enclosed.

As brief background to this appeal, on November 22, 2019, I submitted a request to USAMRDC under the FOIA for all records, including purchase records, billing, and shipping information, and associated correspondence, related to the 2019 purchase by the U.S. Army of a supply of tafenoquine (Arakoda™), a new antimalarial drug which is pending initial operational testing among U.S. service members.

On December 9, 2019, Ms. Nancy Gaynor or USAMRDC responded to my request inquiring as to whether Contract Number W81XWH-19-C-0181, described as the official record of this purchase, and associated billing records and shipping records would be responsive to my request. On December 9, 2019, I confirmed in a reply to Ms. Gaynor that these materials, together with any associated correspondence, would be responsive to my request.

On February 12, 2020, Mr. Brian Martin, USAMRDC Initial Denial Authority, provided a partial response to my request, consisting of a redacted copy of Contract Number W81XWH-19-C-0181, which describes a contract between USAMRDC and the listed contractor 60 Degrees Pharmaceuticals, in the total amount of $2,137,500, wherein significant portions were redacted under a claimed FOIA exemption as per 5 U.S.C. § 552(b)(4) (hereafter referred to as the FOIA "(b)(4)", or the "trade secrets" exemption), including quantities of drug, unit prices, and total amounts, as listed in the original document primarily by contract item line number ("CLIN"). In its denial letter (the “original denial letter”), Mr. Martin noted that these redactions were made "to protect trade secrets and commercial or financial information obtained from a person emphasis added that is privileged or confidential." Mr. Martin also claimed that the information being protected "is current and if released could compromise the submitter's profit margin on the contract price, labor rates, or staffing and subcontractors."

On March 4, 2020, I appealed this denial to your office and outlined the reasons for my appeal, noting that few if any of these redactions are permitted under the (b)(4) exemption.

On July 14, 2020, I received additional documents in response to my original request, and which satisfied several other of my grounds for my March 4, 2020 appeal, not described above. I thank your office for these additional documents. However, in its denial letter of July 14, 2020, the initial denial authority, Mr. Christopher Sherman, again noted that certain (b)(4) redactions were made "to protect trade secrets and commercial or financial information obtained from a person that is privileged or confidential," or to protect the "submitter’s profit margin on the contract price, labor rates, or staffing and subcontractors." Namely, in the additional documents provided, quantities of drug, unit prices, and total amounts for the various CLINs have remained subject to (b)(4) redaction.

Since this time, based on documents already released in response to this request, and referencing other publicly-available contract documents available from the federal government, it has become clear that despite the (b)(4) redactions at issue, the contractor has been awarded the total contract award of $2,137,500 only for CLINs 0001 and 0002, comprising the initial solicitation procurement of 7,500 "packages" or boxes of the drug, with each package comprising 16 tablets (with an expiration date in November 2020), for a total of 120,000 tablets.

Thus, it is clear that the contractor's cost, per "package", is $285, for a per-tablet cost of approximately $17.81. This cost, which reflects a price proposal offered to the government under requirements of a sole-source contract, reflects the price the contractor must offer to their best or preferred customer. This is thus a minimum cost, with the price extended to less-preferred customers expected to be greater than this.

With such minimum contractor cost data already able to be inferred by competitors based on publicly-available information, release of the (b)(4) redacted data can no longer be claimed to risk compromising the "profit margin" of the contractor, 60 Degrees Pharmaceuticals, as claimed by USAMRDC.

Additionally, as previously noted, such a claim would only have merit if release of the unit pricing could be reasonably expected to affect the marketability of the drug. However, tafenoquine for prevention of malaria (marketed by the contractor as Arakoda™) is under patent protection and has no generic competition (see, for example: https://60degreespharma.com/wp-content/uploads/2019/12/60P-PR-Release_Arakoda_Shipping_18Nov2019.pdf), and no other drugs are available that share tafenoquine's unique indication for worldwide prevention of malaria with weekly dosing. For drugs with truly unique indications, for which no acceptable substitutes are available, the market (including the U.S. military market) would be expected bear the full cost of the drug, regardless of economic considerations.

The USAMRDC’s claim that release of unit cost information could compromise the "profit margin" of the contractor continues to imply that either USAMRDC or the contractor, 60 Degrees Pharmaceuticals, believe that acceptable substitutes to Arakoda™ are available on the market, and that economic considerations, such as cost of the drug, may indeed affect the drug's marketability and commercial viability as an antimalarial . However, as previously noted, such an argument seemingly contradicts USAMRDC claims that Arakoda™ is an essential new drug for which no substitutes are available, including that the drug "fulfills an unmet military need" (see https://www.army.mil/article/212996/usammda_celebrates_fda_approval_of_antimalarial_drug_tafenoquine). If the drug truly does fulfill an "unmet military need", then no risk to the contractor can exist from release of the redacted unit prices and total amounts claimed as "trade secrets".

For these reasons, the claimed (b)(4) exemptions cannot reasonably apply, and the FOIA 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

From: U.S. Army Medical Research and Materiel Command

Dr. Nevin,

Please see attached response from OGC on your appeal related to your FOIA Request FP-20-008014. We consider this appeal closed.

MSG Mark A. Johnson
Chief Paralegal NCO
Office of the General Counsel

From: U.S. Army Medical Research and Materiel Command

Good morning,

The response attached to the email sent on July 29, 2020 was OGC’s final response to the appeal and we consider this appeal closed. I’ve attached it here again for your convenience.

V/r,

MSG Johnson

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