FOIA Response and Appeal Summary:

The official FOIA Response was received on September 20, 2024. A telephone discussion occurred with a FOIA Appeals representative who assisted with understanding the process as well as answering appeals-related questions. It was mentioned that Actinium Pharmaceuticals had released the FOIA Requested information through SEC reports, publications, and press releases.

The appeal was submitted to the FDA on September 23, 2024. It is expected
they will process the appeal after September 26, 2024, when the FOIA Appeals representative returns from annual leave. There is a pending question of when to expect a response. 

Specific Reasons:

(1) The FOIA information requested from the FDA, in whole or part, has been previously publicly disclosed, acknowledged, published, and generally made available by Actinium Pharmaceuticals, Inc. in SEC 10-K, 8-K, 10-Q reports, and peer-reviewed medical journals that provide the basis for the FOIA Requests. 

(2) Given the information above has previously been published or made generally available, the following regulations and subsections apply to reconsideration of the FDA Response.

·        21 C.F.R. § 20.61(f)(2)
·        21 C.F.R. § 601.50(a)
·        21 C.F.R. § 601.51(b)&(d)
·        21 C.F.R. § 314.430(b)&(d)
·        45 C.F.R. § 5.1(a) & 5.2(a)
·        5 U.S.C. § 552(a)

(3) 45 C.F.R. § 5.31(c) Exemption 3 is not applicable, specifically, 42 U.S.C. §282(j)(6) that applies to the limited disclosure of clinical trial information. The FOIA Requests do not ask the Secretary to disclose any clinical trial information from the SIERRA trial (clinicaltrials.gov identifier: NCT02665065) that is not otherwise publicly available.

(4) 45 C.F.R. § 5.31(d) Exemption 4 is not applicable. The FOIA Requests do not ask for trade secret and confidential commercial information of Actinium Pharmaceuticals, Inc. as defined by 21 C.F.R. § 20.61. The FOIA requests FDA administrative data, documentation, dates, and meetings pertaining to a BLA which have been generally made known to the public by Actinium Pharmaceuticals, Inc.

(5) 5 U.S. Code § 552(a) is applicable and requires the FDA CDER to make available to the public information when requested, in whole or part, agency final opinions, including concurring and dissenting opinions, as well as orders, made in the adjudication of cases to Actinium Pharmaceuticals, Inc. to which 5 U.S. Code § 552(a) is applicable and 18 U.S.C. § 1905 and 21 U.S.C. § 331(j) are not.

(6) With consideration of the FDA CDER concern for competitive harm as it applies to 5 U.S.C. § 552(a)(8)(A)(i) and 552(b)(4) that requires the FDA to withhold information, 

            (A) Actinium claimed they “have been assigned a BLA number.” This publicly discloses and acknowledges the existence of a BLA which is the basis of regulatory applicability in Paragraph (2).

            (B) Actinium claimed the "FDA determined that the Phase 3 SIERRA trial is not adequate to support a BLA filing for Iomab-B”, “additional head-to-head randomized clinical trial demonstrating overall survival benefit with Iomab-B is required by FDA to support a BLA filing”, and “the FDA has now provided definitive feedback regarding the clinical portion that the SIERRA trial alone is not adequate to support a BLA filing.” FDA disclosure would provide factual clarity to Actinium’s claim.

            (C) It is not reasonably foreseeable for the FDA CDER to expect that providing clarity to the aforementioned would harm an interest protected by an exemption. Additionally, 5 U.S.C. § 552(a)(8)(A)(ii) permits partial disclosure of information and records and for the FDA CDER to take reasonable steps necessary to segregate and release nonexempt information.

Prayer for Reconsideration and Relief. FDA reconsideration of the FOIA response would provide FDA CDER agency transparency and understanding to patients, family, doctors, company employees, and company investors who have yet to fully understand why the FDA CDER determined Actinium’s BLA filing was inadequate when Iomab-B met the primary endpoint and proved to be safe for use in clinical trials. 

As of writing, there were 248 people in support of an FDA Citizen’s Petition that would request the FDA CDER accept Actinium Pharmaceuticals 131I-Apamistamab (Iomab-B) BLA for approval consideration. These are the real people who have already been socially, emotionally, and financially harmed by the FDA CDER determination and the resulting public disclosure made by Actinium Pharmaceuticals on August 5, 2024. Reference: https://change.org/aml-iomab-b