FDA Stimulant Shortage

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

2023-9090

FDA23097405
Submitted Oct. 14, 2023
Due Nov. 13, 2023
Est. Completion None
Status
Awaiting Response

Communications

From: K. Braddock

Subject: Freedom of Information Act Request: FDA Stimulant Shortage

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To Whom It May Concern:

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

1. Any correspondence, memos, emails, or other written communications, including both internal and external communications, related to the ongoing shortage of prescription stimulant medication for the treatment of ADHD.

2. Any reports, studies, or analyses conducted by or for the FDA on the factors contributing to the shortage and any plans made by the agency to address the ongoing shortage.

3. Information on any regulatory actions, such as inspections, approvals, recalls, or labeling changes, taken by the FDA in response to the prescription stimulant medication shortage.

4. Any records related to the FDA's collaboration with other federal agencies, including but not limited to the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA), in addressing the shortage.

5. Any records related to communications or meetings between the FDA and pharmaceutical manufacturers, distributors, media, or industry associations regarding the production, distribution, and availability of prescription stimulant medication for ADHD.

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,

K. Braddock

From: Food and Drug Administration

Subject: FOI Request Received

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*** This is an automated message. Please do not reply to this email. ***
Reference: FDA23097405
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administration
pursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed;
if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request.
If your request is not sufficiently described,
or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.

From: Food and Drug Administration

Subject: FDA Receipt of FOI Request Control # 2023-9090

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Control number: 2023-9090
Please find the attached acknowledgement regarding your FOIA request. Note: Do NOT reply directly to this E-mail

From: Food and Drug Administration

Subject: 2023-9090 Braddock ADHD medicine shortage FOIA status inquiry

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Good afternoon,

The FDA FOIA Office just received the attached scanned copy a status inquiry that you sent via hardcopy mail to the Maryland office. I am writing to let you know that our tracking system shows this request has been assigned to the Center for Drug Education and Research (CDER) for processing. Accordingly, I've reached out to CDER FOIA staff and have asked them to provide you with a more detailed status update.

In the meantime, I wanted to let you know that you should send future status update inquires via email to this email address. Doing so, will avoid delays caused by sending hardcopy materials to the physical address listed in your letter.

Sincerely,

C.
___________________________
Ms. Charis Wilson, PhD, CRM
Denials & Appeals Officer
Freedom of Information Division
Office of the Commissioner
Food & Drug Administration

From: Food and Drug Administration

Subject: Status update for 2023-9090

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Good morning,

This email is in response to your status update inquiry regarding FOIA Request No. 2023-9090. Please be advised that CDER's FOIA requests are processed in the order in which they are received (FIFO-first in-first-out). The requests are triaged and assigned to either a simple track or complex track based on the information the requester is seeking. Your request was assigned to the complex track. The wait time for complex requests is approximately 18-24 months. Currently, your request is #1060 in a queue of #1274 pending FOIA requests.

Regards

Sheryl Douglas-McKay
Consumer Safety Officer
Office Of Regulatory Policy
Division of Information Disclosure Policy
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Tel: 240-402-7360
sheryl.douglas-mckay@fda.hhs.gov<mailto:sheryl.douglas-mckay@fda.hhs.gov>

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