FDA Advisory Committee member financial disclosures

To Whom It May Concern:

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

This is a Document Request by Jeanne Lenzer under the Freedom of Information Act (“FOIA”), 5 U.S.C. § 552, for the following records:

All financial disclosure forms (Form FDA 3410 and/or Form OGE 450) for each voting FDA advisory committee member for the June 10, 2024 PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE to review donanemab. I have copies of the two waivers granted but I am requesting the forms for each voting committee member.
The 11 voting members are:
1. Thomas Montine
2. Merit Cudkowicz
3. Tanya (Tatyana) Simuni
4. Cynthia Carlsson
5. Nilufer Erteken-Taner
6. Costantino Iadecola
7. Kathleen Poston
8. Daniel Press
9. Dean Follman
10. Sara Dolan
11. Colette Johnston

I request that all records be produced in their native electronic formats with any attached metadata included, so long as such electronic files can be opened using standard commercially available software. If the files cannot be produced in this manner, we request that records be produced in an alternative electronic format that is text-searchable. 5 U.S.C. § 552(a)(3)(B)

Fee Waiver Request

A waiver of search and review fees is appropriate here because disclosure of the requested information is in the public interest under 5 U.S.C. § 552(a)(4)(A)(iii) and 45 C.F.R. § 5.54(a), (b)(1)-(2), and because the request is not primarily in the requestor’s commercial interest, 45 C.F.R.§§ 5.45(a), (b)(3)(ii).

Disclosure Is in the Public Interest

Disclosure of the requested information is likely to contribute significantly to the public understanding of the U.S. government’s review process for the drug donanemab (Kisunla). 45 C.F.R. § 5.54(b)(1). In particular, the requested information will shed light on exceptional events, a mechanism used by regulators to account for and exclude air pollution, information which is not “already in the public domain.” 45 C.F.R. § 5.54(b)(2)(i). As a peer-reviewed medical journal, The BMJ has demonstrated its “ability and intention to effectively convey information to the public.” 45 C.F.R. § 5.54(b)(2)(ii). I am an independent professional journalist writing for The BMJ, a global medical journal.

Limitation of Fees

We are also entitled to a limitation of fees because we are a member of the news media. 45 C.F.R. § 5.53(b); 5 U.S.C. § 552(a)(4)(A)(ii)(II). Accordingly, even if our application for a waiver of all fees is denied, we are entitled to a limitation of fees. As a news media requester, we are “entitled to search time, review time, and up to 100 pages of duplication” and can be charged only duplication fees after the first 100 pages or its cost equivalent. 45 C.F.R. § 5.53(b). We request that the information be provided in its native electronic format, and thus there should be no duplication fees.

As a medical journal with an investigative news section, The BMJ is primarily engaged in disseminating information to the public. The approval of donanemab to treat Alzheimer’s disease, has profound effects on the treatment and potential adverse health effects of more than a million people in the US, and many more internationally.

Request for Explanation of Withholdings and Redactions

If this request is denied in whole or in part, please provide a reasonable description of any withheld materials and a justification for all such withholdings that includes reference to the specific FOIA exemptions authorizing withholding and specific reasons why such exemptions apply. 45 C.F.R. § 5.31. An agency shall withhold information only if “the agency reasonably foresees that disclosure would harm an interest protected by an exemption” or “disclosure is prohibited by law.” 5 U.S.C. § 552(a)(8)(A)(i). We therefore request that if the FDA determines that an exemption applies that it also provide specific reasons why disclosure would harm any interest protected by such exemption. An agency shall also “consider whether partial disclosure of information is possible whenever the agency determines that a full disclosure of a requested record is not possible” and “take reasonable steps necessary to segregate and release nonexempt information.” Id. 552(a)(8)(A)(ii). We therefore request that the FDA release all segregable portions of otherwise exempt material.

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Thank you for your prompt attention to this request. If you have any questions or concerns about what I am seeking, please do not hesitate to contact us at the email address and/or phone number below.

Sincerely,
Jeanne Lenzer
Independent medical investigative journalist
The BMJ
19 Ridge St., Kingston, NY 12401
jeanne.lenzer@gmail.com
845.399.0405

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