Notification for Healthcare Providers of Mefloquine Box Warning

Dr. Remington Nevin filed this request with the Army - United States Department of the Army of the United States of America.
Tracking #

14-F-1274

Status
Completed

Communications

From: Remington Nevin

To Whom It May Concern:

This is a request under the Freedom of Information Act. I hereby request the following records:

All copies of notification messages and other correspondence received by the Office of the Assistant Secretary of Defense (Health Affairs) from the military services and Joint Task Force, National Capital Region-Medical, in response to the OASD(HA) memorandum dated August 12, 2013, subject: Notification for Healthcare Providers of Mefloquine Box Warning, describing efforts made by the services and JTF to ensure that all prescribing healthcare providers and pharmacists are made aware of the FDA box warning on mefloquine as current DoD guidance regarding use of the drug, as described in the referenced memorandum.

I also request that, if appropriate, fees be waived as I believe this request is in the public interest. The requested documents will be made available to the general public free of charge as part of the public information service at MuckRock.com, processed by a representative of the news media/press and is made in the process of news gathering and not for commercial usage.

In the event that fees cannot be waived, 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,

Remington Nevin

From: Department of Defense, Office of the Secretary of Defense

The request has been forwarded from one agency to another agency or department for further review or follow up.

From: MuckRock.com

To Whom It May Concern:

I wanted to follow up on the following Freedom of Information request, copied below, and originally submitted on July 10, 2014. Please let me know when I can expect to receive a response, or if further clarification is needed.

Thank you for your help.

From: Marye, Charles

Dear Remington Nevin: This is an interim response to your Freedom of Information Act (FOIA) request dated July 10, 2014, which was received in this office on August 12, 2014.  Your request has been assigned case number 14-F-1274 and we ask that you use that number when referring to your request. With regard to your request for a waiver of any applicable fees, a fee waiver is appropriate when "disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations and activities of the government and is not primarily in the commercial interest of the requester." 5 U.S.C. § 552(a)(4)(iii) In making a determination, six factors are considered as to whether your request satisfies this statutory standard: (1) whether the subject of the requested records concerns the operations or activities of the government; (2) whether the disclosure is likely to contribute to an understanding of government operations or activities; (3) whether disclosure of the requested information will contribute to the understanding of the general public; (4) whether the disclosure is likely to contribute significantly to public understanding of government operations and activities; (5) whether the requester has a commercial interest that would be furthered by the requested disclosure; and, (6) whether any such commercial interest outweighs the public interest in disclosure.
While the requested information does concern the operations and activities of the government and does not appear to be intended for a commercial interest, it is not clear how the responsive documents - should they exist - would significantly contribute to the public understanding of the operations and activities of the government. After carefully reviewing your request I am denying your fee waiver request because the information stated does not support how the documents will significantly contribute to the public's increased understanding of the operations and activities of government.
Please be aware that we reserve the right to grant a fee waiver should a search find documents that meet the criterion of a public interest fee waiver as described in the previous paragraph.
I have determined that you should be placed in the "other" category for fee purposes as you have indicated that you do not seek access to these records for commercial purposes. The "other" fee category affords you two hours of search time and 100 pages of duplication free of charge. As you did not provide any willingness to pay, search will be halted after your two free hours have been expended. If you wish to add a willingness to pay, please contact the action officer assigned to your request at your earliest convenience.
We will be unable to respond to your request within the FOIA’s 20 day statutory time period as there are unusual circumstances which impact on our ability to quickly process your request.  These unusual circumstances are:  (a) the need to search for and collect records from a facility geographically separated from this Office; (b) the potential volume of records responsive to your request; and (c) the need for consultation with one or more other agencies or DoD components having a substantial interest in either the determination or the subject matter of the records.  For these reasons, your request has been placed in our complex processing queue and will be worked in the order the request was received.  Our current administrative workload is 1554 open requests.
If you would like to discuss how to limit your request in order to speed the processing time, we would be pleased to discuss how you might modify your request.  The action officer assigned to your request is Charles Marye at (571) 372-0407. The toll free number for this Office is 866-574-4970. You may not be aware that we maintain a website and electronic reading room at: http://www.dod.mil/pubs/foi/ If you are not satisfied with this action, you may appeal to the appellate authority, the Director of Administration and Management, Office of the Secretary of Defense, by writing directly to the Defense Freedom of Information Policy Office, Attn: Mr. James Hogan, 1155 Defense Pentagon, Washington, D.C. 20301-1155. Your appeal should be postmarked within 60 calendar days of the date of this letter, should cite the case number 14-F-1274, and should be clearly marked "Freedom of Information Act Appeal."
Thank you, Charles Marye Office of Freedom of Information
Department of Defense
1155 Defense Pentagon
Washington, DC 20301-1155
FAX: (571) 372-0500

From: Remington Nevin

Defense Freedom of Information Policy Office
Attn: Mr. James Hogan
1155 Defense Pentagon
Washington, D.C. 20301-1155

Re: Freedom of Information Act Appeal, Case #14-F-1274

This is an appeal under the Freedom of Information Act. I hereby appeal the denial of my fee waiver request as described in your letter of August 15, 2014 on the basis that it can be demonstrated that disclosure of the requested information would substantially benefit the public interest.

As described in the original FOIA request, the requested information pertains to “efforts made by the services and JTF to ensure that all prescribing healthcare providers and pharmacists are made aware of the FDA box warning on mefloquine as current DoD guidance regarding use of the drug”. In substantiation of the claim that release of the requested information would benefit the public interest, it can be demonstrated that: 1. The requestor has utilized similar information to inform both Senate testimony and invited commentary to the Food and Drug Administration on the use of mefloquine within the Department of Defense, and 2. These efforts have led to widespread media attention focusing attention on patterns of widespread misprescribing of mefloquine within the Department of Defense, and the associated health risks of such misprescribing (see, e.g. popular media stories at http://www.cbsnews.com/news/elite-army-units-to-stop-taking-anti-malarial-drug/ and http://www.cbsnews.com/news/some-us-troops-haunted-by-anti-malaria-drugs-side-effects/ where the requestor is directly quoted).

These facts reasonably substantiate that release of the requested information to the requestor would constitute an act “significantly contributing to the public’s increased understanding of the operations and activities of government”.

In accordance with 5 USC § 552 (a)(4)(A)(ii)(II), fees or FOIA requests “shall be limited to reasonable standard charges for document duplication when records are not sought for commercial use and the request is made by an educational or noncommercial scientific institution, whose purpose is scholarly or scientific research; or a representative of the news media. As such, should your agency deny my request, this requestor is nonetheless entitled to a waiver of any search fees, and the costs of your agency’s compliance with my request must be limited to the actual costs of duplication.

Although your agency has claimed the existence of 3 “unusual circumstances” justifying the extraordinary delay in responding to this request, 5 U.S.C. § 552(a)(6)(B) permits your agency only an additional 10 days to respond to my request even in the presence of such “unusual circumstances”. Additionally, on the basis of the information requested, it is questionable whether 2 of the 3 “unusual circumstances” identified by your office may reasonably apply to this particular request.

You note one “unusual circumstance” is the “potential volume of records responsive to your request. This request asks only for “copies of notification messages and other correspondence received by the Office of the Assistant Secretary of Defense (Health Affairs) from the military services and Joint Task Force, National Capital Region-Medical, in response to the OASD(HA) memorandum dated August 12, 2013, subject: Notification for Healthcare Providers of Mefloquine Box Warning”. This memorandum was addressed to only four offices: 1. The Assistant Secretary of the Army (Manpower and Reserve Affairs), 2. The Assistant Secretary of the Navy (Manpower and Reserve Affairs), 3. The Assistant Secretary of the Air Force (Manpower and Reserve Affairs), and 4. The Commander, Joint Task Force, National Capital Region-Medical. It is not plausible that these four addressees, or their designees, generated a large “potential volume of records” in responding formally to the August 12, 2013 request for information. In this regard, please consider this appeal as clarification to interpret the original FOIA request as limiting the “potential volume of records responsive” to this request to the four formal replies received, together with any notification messages or correspondence attached thereto.

You also note another “unusual circumstance” is the “need to search for and collect records from a facility geographically separated from this Office”. As this FOIA request asks only for those documents specifically requested by the Assistant Secretary of Defense (Health Affairs) in response to the August 12, 2013 memorandum, it is not plausible that these documents both: 1. would not already be organized and immediately accessible to a search of existing documents maintained by the Assistant Secretary of Defense (Health Affairs) , and 2: would not readily producible within the statutory period through a simple search of existing correspondence.

Thank you in advance for your anticipated cooperation in this matter.

Sincerely,

Remington Nevin

From: Army - United States Department of the Army

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

From: Army - United States Department of the Army

A letter stating that the request appeal has been rejected.

From: Remington Nevin

Will Kramer
Department of Defense
Freedom of Information Policy Division
1155 Defense Pentagon
Washington, D.C. 20301-1155

Re: Freedom of Information Act, Case #14-F-1274

Dear Mr. Kramer,

I am in receipt of a letter dated October 1, 2014 from the Department of Defense Office of the Deputy Chief Management Officer, denying my request for a fee waiver for the above referenced request. This letter is to clarify that, as described below, as my request is very likely to be able to be completed within 2 hours of free search time, and within 100 pages of duplication provided at no charge by your office, I request your office proceed with my original request within these free allowances.

In my original request of July 10, 2014, I requested: “All copies of notification messages and other correspondence received by the Office of the Assistant Secretary of Defense (Health Affairs) from the military services and Joint Task Force, National Capital Region-Medical, in response to the OASD(HA) memorandum dated August 12, 2013, subject: Notification for Healthcare Providers of Mefloquine Box Warning, describing efforts made by the services and JTF to ensure that all prescribing healthcare providers and pharmacists are made aware of the FDA box warning on mefloquine as current DoD guidance regarding use of the drug, as described in the referenced memorandum”.

This memorandum was addressed to only four offices: 1. The Assistant Secretary of the Army (Manpower and Reserve Affairs), 2. The Assistant Secretary of the Navy (Manpower and Reserve Affairs), 3. The Assistant Secretary of the Air Force (Manpower and Reserve Affairs), and 4. The Commander, Joint Task Force, National Capital Region-Medical. In your initial reply of August 15, 2014, your office stated that you may be unable to respond to my request within the FOIA’s 20 day statutory period owing to a large “potential volume of records” responsive to my request.

As clarified in my appeal of August 27, 2014, it is not plausible that these four addressees, or their designees, generated a large “potential volume of records” in responding formally to the August 12, 2013 request for information. In this regard, in my appeal of August 27, 2014, I directed that you consider my appeal as clarification to interpret the original FOIA request as limiting the “potential volume of records responsive” to this request to the four formal replies received, together with any notification messages or correspondence attached thereto.

In my fee waiver denial of October 1, 2014, I was informed I would be entitled to two free hours of search time, and 100 pages of duplication at no charge. As it is not plausible that the four formal replies, as described above, would not: 1. already be organized and immediately accessible to a search of existing documents maintained by the Assistant Secretary of Defense (Health Affairs) within such a two hour search period, and 2: be readily able to be duplicated in 100 pages or less through a simple search of existing correspondence, I hereby direct you to proceed with processing my request within the free allowances you describe.

In the very unlikely event that you are unable to locate these four formal replies within the time limit described above, or such a search identifies greater than 100 pages of responsive documents, at that time, please provide me with an estimate of any additional fees necessary to fully process my request.

I thank you in advance for your anticipated cooperation in this matter.

Sincerely,

Remington Nevin

From: Marye, Charles C CIV WHS ESD (US)

Thank you

Charles Marye
OSD/JS Office of Freedom of Information
(571) 372-0407

NIPR: charles.c.marye.civ@mail.mil
SIPR: charles.c.marye.civ@mail.smil.mil

From: MuckRock.com

To Whom It May Concern:

I wanted to follow up on the following Freedom of Information request, copied below, and originally submitted on July 10, 2014. Please let me know when I can expect to receive a response, or if further clarification is needed. You had assigned it reference number #14-F-1274.

Thank you for your help.

From: Marye, Charles C CIV WHS ESD (US)

Mr. Nevin,
We continue to process your request. It is our policy that each request receives prompt attention, and every effort is made to treat all requesters equally. As previously noted, and unfortunately, our backlog of open requests at the time your request was received was over 1,554. Once I receive a response, all releasable records, if any, cannot be provided to you until all processing is completed. As soon as that occurs, I will send you a formal response letter to your request. Please note all documents are reviewed before we respond. Further note the unusual circumstances concerning your cases are: (a) the need to search for and collect records from a facility geographically separated from this Office; (b) the potential volume of records responsive to your request; and (c) the need for consultation with one or more other agencies or DoD components having a substantial interest in either the determination or the subject matter of the records. These 3 factors do have an impact on the processing of your case. The search for the records you have requested is still ongoing. Once that search has been completed, we will be able to provide an estimated completion date. I appreciate your patience and understanding in this matter.

Sincerely,

Charles Marye
OSD/JS Office of Freedom of Information
(571) 372-0407

NIPR: charles.c.marye.civ@mail.mil
SIPR: charles.c.marye.civ@mail.smil.mil

From: Army - United States Department of the Army

A cover letter granting the request and outlining any exempted materials, if any.

From: Army - United States Department of the Army

A copy of documents responsive to the request.

From: Marye, Charles C CIV WHS ESD (US)

Mr. Nevin,

Attached is the final response to your FOIA request 14-F-1274.

Sincerely,

Charles Marye
OSD/JS Office of Freedom of Information
(571) 372-0407

NIPR: charles.c.marye.civ@mail.mil
SIPR: charles.c.marye.civ@mail.smil.mil

From: Marye, Charles C CIV WHS ESD (US)

Mr. Nevin,
I received your request for an update.
We have already responded to 14-F-1274. Please turn off your automatic status update requests for case 14-F-1274. A copy of that response is attached.

Please note you also reference your case 14-F-1492. We continue to process 14-F-1492. It is our policy that each request receives prompt attention, and every effort is made to treat all requesters equally. As previously noted, and unfortunately, our backlog of open requests at the time your request was received was over 1,554. Once I receive a response, all releasable records, if any, cannot be provided to you until all processing is completed. As soon as that occurs, I will send you a formal response letter to your request. Please note all documents are reviewed before we respond. Further note the unusual circumstances concerning your cases are: (a) the need to search for and collect records from a facility geographically separated from this Office; (b) the potential volume of records responsive to your request; and (c) the need for consultation with one or more other agencies or DoD components having a substantial interest in either the determination or the subject matter of the records. These 3 factors do have an impact on the processing of your case. I appreciate your patience and understanding in this matter.

Sincerely,

Charles Marye
OSD/JS Office of Freedom of Information
(571) 372-0407

NIPR: charles.c.marye.civ@mail.mil
SIPR: charles.c.marye.civ@mail.smil.mil

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