P.O.

Box 10841
Eugene, Oregon 97440
p/f: 541.257.8878
info@t1df.org
August 1, 2019
www.t1df.org


Food and Drug Administration Sent via FedEx
Division of Freedom of Information
5630 Fishers Lane, Room 1035
Rockville, MD 20857

RE: FOIA request — Intranasal Glugagon Formulation based on Glucagon (N020928) or

glucagon hydrochloride (N020918), including but not limited to Baqsimi (NDA: 210134)

To Whom It May Concern:

Would you please process the following request:

A. Requestor's name, address, and telephone number.

Type 1 Diabetes Defense Foundation, ℅ Charles Fournier

3059 Hendricks Hill Drive, Eugene OR 97403
(206) 643-1479

B. A description of the records being sought.

This FOIA request concerns all intra-nasal powder formulations based on glucagon (N020928) or
glucagon hydrochloride (N020918), including but not limited to the recently approved Baqsimi
(NDA: 210134).
Excluded records:

This FOIA request does not concern internal FDA documents (created by the FDA for internal
evaluation purposes and not communicated to any private or public third parties), emails, records,
meetings, communication, presentations, analysis or review notes concerning the above-mentioned
intranasal glucagon formulations.
This FOIA does not concern glucagon formulations approved for veterinary purpose or purposes
other than the treatment of insulin-induced severe hypoglycemia in children and adults. The records
of the following agencies are outside the scope of this FOIA:

• Center for Devices and Radiological Health (CDRH)

• Center for Food Safety and Applied Nutrition (CFSAN)
• Center for Tobacco Products (CTP)
• Center for Veterinary Medicine (CVM)

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Included records:
This FOIA primarily concerns, but is not limited to, the records of the following two divisions:

• Center for Biologics Evaluation and Research (CBER)

• Center for Drug Evaluation and Research (CDER)
Relevant records may also be in the custody of other divisions or groups.

This FOIA request concerns presentations to, phone calls with, in-person and virtual meetings with
and written communications exchanged with or received from private or public third parties
concerning intranasal glucagon formulations from January 1, 1992, to July 25, 2019. These third
parties include, but are not limited to, Eli Lilly, Novo Nordisk, Locemia Solutions, JDRF, the
American Diabetes Association. More specifically, the requested records include but are not limited
to:
LOGS/LISTS:

• Logs of all meetings, including but not limited to in-person meetings, conferences,
teleconferences, presentations.

• Logs of all communications, including but not limited to phone communications (call logs),
written communications, electronic communications (included email logs) with third parties.

• Logs of all documents exchanged with or received from any third party including all records,
letters, submittals, applications, exhibits, filings, either on paper or electronically.
COPIES/RECORDS:

• All meeting minutes, including but not limited to minutes, notes and summaries of in-person
meetings, conferences, teleconferences, presentations.

• All communications, including but not limited to the notes and transcripts of phone
communications, written communications, electronic communications (including emails).

• All documents exchanged with or received from any third party including all records, letters,
submittals, applications, exhibits, filings, either on paper or electronically.

C. A statement concerning willingness to pay fees, including any limitations.

The purpose of this request is primarily for educational and research purposes. We are
researching the causes for the 27-year delay between the filing of the first patent for nasal glucagon
formulations and the submission for approval (and delayed approval) of the first application
(Baqsimi). We hope that the outcome of this research will assist patient stakeholders in reducing the
lag time between research and marketing for lifesaving emergency products.

This endeavor was initiated when we compared Baqsimi’s approval pathway to similar
products. A similar emergency product, Naloxone, received FDA approval in 2015 for an intranasal
reformulation of its approved IM powder in a matter of months, based on a single trial complete
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concurrently with the application process. This accelerated approval pathway stands in stark contrast
to the delayed approval of a glucagon nasal formulation. The initial patent for an intranasal glucagon
formulation was filed by Novo Nordisk in 1992. The first application of this rather simple patent is
Baqsimi (NDA: 210134), submitted for approval 27 years after the filing of Novo Nordisk’s patent.
IN carrier powder and delivery devices have long been commoditized. There is no obvious
explanation for this delay, especially in the context of the growing literature documenting the high
rate of administration failures of the current IM emergency kits and the discriminatory treatment that
an injectable can meet with, especially for school-age children. Discrimination (schools’ refusal to
provide emergency care) and a high-rate of delivery failures even among trained professionals have
led endocrinologists to recommend sub-optimal standards of care. We also note that the development
of a simpler glucagon patch developed by Zosano Pharma Corp. was terminated when Novo Nordisk
and Eli Lilly refused to guarantee access to approved glucagon. These matters have received no
media scrutiny, and we are not aware of any ongoing research endeavor on this topic.
We are therefore reviewing this matter to understand why an IN glucagon formulation was not
submitted for approval until early 2018 and was not approved until July 2019—27 years after the
filing of the initial patent. This delay is consequential from a policy and public health perspective.
We hope that communications between the FDA and market actors will shed some light on this
peculiar delay and assist us in devising market-based, policy or regulatory solutions. The lives of
many individuals literally depend on preventing a similar delay to the development and marketing of
effective formulations and improved administration routes for life-saving emergency drugs.
Considering the critical importance of this endeavor for people with life-threatening medical
conditions, the fact that we are the only entity currently researching this issue and T1DF’s 501(c)(3)
charitable purpose—but also T1DF’s extremely limited annual budget (less than $20,000)—we
therefore request that the fees and costs associated with this request be waived in their entirety.
Thank you for your consideration of these matters.

Respectfully submitted,

Charles Fournier, Vice President

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