FDA on lecanemab
| Tracking # |
2024-2517 FDA24101979 |
| Submitted | March 8, 2024 |
| Est. Completion | None |
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Communications
From: Jeanne Lenzer
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
March 8, 2024
Food and Drug Administration
Division of Freedom of Information (HFI-35)
RE: Expedited Freedom of Information Act request
Dear FOIA Officer:
Pursuant to the Freedom of Information Act, 5 U.S.C. § 552a, and under FDA’s expedited processing regulation 21 CFR § 20.44 (since this request was previously filled/closed), I am requesting all materials responsive to Control #2024-1977 THE NEW YORK TIMES All correspondence between FDA agency staff and drug sponsors of Lecanemab (application 761269Orig1s000) which includes: 1. All meeting records/minutes documenting interactions between agency staff and Esai inc. or Biogen personnel regarding the drug, lecanemab (Leqembi) etc closed feb 28
I am a professional journalist writing for Inquiry, the investigative unit of The Conversation, a global newsroom with 20 million monthly readers. The information I am requesting deserves an expedited response because it relates to harm to the health and wellbeing of the public.
As an investigative journalist, I request a waiver of fees associated with processing this FOIA request and duplicating responsive records.
Thank you for your attention to this request.
Sincerely,
Jeanne Lenzer
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,
Jeanne Lenzer
From: Food and Drug Administration
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA24101979
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
Control number: 2024-2517
Please find the attached acknowledgement regarding your FOIA request. Note: Do NOT reply directly to this E-mail
From: Food and Drug Administration
Control number: 2024-2517
Please find the attached response regarding your expedite request. Note: Do NOT reply directly to this E-mail
From: Food and Drug Administration
Dear Requester,
I am writing in response to your request for a copy of the response to FOIA 2024-1977, which was withdrawn by the requester prior to a response by FDA. Therefore, we have no responsive records.
You have the right to appeal this determination. Your appeal should clearly identify the agency determination that is being appealed. It would be helpful if you provide specific reasons explaining why you believe the agency's adverse determination should be reconsidered. By filing an appeal, you preserve your rights under FOIA and give the agency a chance to review and reconsider your request and the agency's decision. Your appeal must be mailed within 90 days from the date of this response, to: Director, Office of the Executive Secretariat, U.S. Food & Drug Administration, 5630 Fishers Lane, Room 1050, Rockville, MD 20857, or emailed within 90 days from the date of this response to FDAFOIA@fda.hhs.gov<mailto:FDAFOIA@fda.hhs.gov>. Please clearly mark both the envelope and your letter "FDA Freedom of Information Act Appeal."
If you would like to discuss our response before filing an appeal to attempt to resolve your dispute without going through the appeals process, please contact me at 301-796-8976 or Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>.
Please contact me if you have questions about your request. You may also contact the FDA FOIA Public Liaison for assistance at: Office of the Executive Secretariat, US Food & Drug Administration, 5630 Fishers Lane, Room 1050, Rockville, MD 20857, E-mail: FDAFOIA@fda.hhs.gov<mailto:FDAFOIA@fda.hhs.gov>.
If you are unable to resolve your FOIA dispute through our FOIA Public Liaison, the Office of Government Information Services (OGIS), the Federal FOIA Ombudsman's office, offers mediation services to help resolve disputes between FOIA requesters and Federal agencies. The contact information for OGIS is as follows: Office of Government Information Services, National Archives and Records Administration, 8601 Adelphi Road-OGIS, College Park, MD 20740-6001; telephone at 202-741-5770; toll free at 1-877-684-6448; or facsimile at 202-741-5769; e-mail at ogis@nara.gov<mailto:ogis@nara.gov>.
Sincerely,
Sarah B. Kotler, J.D.
Director, Division of Freedom of Information
US FDA
301-796-8976
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