Mefloquine Active Comparator Adverse Event Data Reported in NDA 21-078 Application

Remington Nevin filed this request with the Food and Drug Administration of the United States of America.
Tracking #

2015-8145

Est. Completion None
Status
Awaiting Appeal

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:

Records of adverse events reported in the mefloquine comparator arms of all active-controlled clinical studies submitted in support of the indication for “prevention of malaria” for NDA 21-078 (Malarone) tablets or pediatric tablets, for example, those reported in Table 4 of the current Malarone prescribing information, to specifically include any raw, free-text, or subject-level data on such adverse events.

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 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,

Dr. Remington Nevin

From: Food and Drug Administration

An acknowledgement letter, stating the request is being processed.

From: Jackson, Gary (CDER)

Dear Mr. Nevin,

In response to your request for a status update for your request related to MALARONE NDA 21-078 - AER please note, the FDA CDER processes FOI requests in a two track system. That system operates on a first in first out basis. Your request has been assigned to the complex queue. Cases assigned to the complex queue generally experience a processing time frame of 18 to 24 months. Your request is in the queue, and will be processed in turn.
Regards,
Gary Jackson
Consumer Safety Officer

Office of Regulatory Policy
Division of Information Disclosure Policy
Center for Drug Evaluation and Research

From: Jackson, Gary (CDER)

Dear Mr. Nevin,

As previously stated regarding your request for a status update for your request related to MALARONE NDA 21-078 - AER please note, the FDA CDER processes FOI requests in a two track system. That system operates on a first in first out basis. Your request has been assigned to the complex queue. Cases assigned to the complex queue generally experience a processing time frame of 18 to 24 months. Your request is in the queue, and will be processed in turn.
Regards,
Gary Jackson
Consumer Safety Officer

Office of Regulatory Policy
Division of Information Disclosure Policy
Center for Drug Evaluation and Research

From: Remington Nevin

Headquarters FOIA Officer
Food and Drug Administration
Division of Freedom of Information
5630 Fishers Lane, Room 1035
Rockville, MD 20857

Re: Appeal of Constructive Denial of Freedom of Information Act Request FDA 2015-8145

Dear Sir or Madam,

This is an appeal under the Freedom of Information Act.

On October 5, 2015, I submitted a request for:

"Records of adverse events reported in the mefloquine comparator arms of all active-controlled clinical studies submitted in support of the indication for 'prevention of malaria' for NDA 21-078 (Malarone) tablets or pediatric tablets, for example, those reported in Table 4 of the current Malarone prescribing information, to specifically include any raw, free-text, or subject-level data on such adverse events."

This request was acknowledged by FDA in a letter dated October 7, 2015. In a message dated November 9, 2015, FDA informed me that the request was in its complex queue, with an expected processing time of 18-24 months. It has now been nearly 24 months, and despite monthly requests for an update on the status of this request, I have received no further response or correspondence from FDA.

The FDA's failure to respond to my request within the time period required by the Freedom of Information Act serves as a constructive denial of my request.

I respectfully request that FDA respond to my appeal within 20 business days.

Sincerely,

Dr. Remington Nevin

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