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Kaplan, Jo Ann (AGO)
From: Kaplan, Jo Ann (AGO) Sent: Wednesday, February 11, 2015
1:57 PM To: 'Hollman, Steven P.' Cc: [email protected];
'[email protected]'; Cook, Susan M.; Gold, Eric (AGO),
Kobick, Julia (AGO); McLaughlin, Anne (AGO) Subject: RE: Zogenix
v. Patrick/Supplemental Submission on Regulatory Developments
It's not my conclusion, Steven; it's the FDA's conclusion.
Unless and until the FDA authorizes Zogenix to include claims
related to abuse-deterrence on the label, FDA has approved the drug
to be marketed only as a non-abuse-deterrent drug. Because the FDA
has approved Hysingla to be marketed with claims related to
abuse-deterrence, Hysingla is most certainly not a similarly
situated drug.
What Judge Zobel called for was a mutual submission simply
notifying the court of the facts and addressing any issue of
mootness, not supplemental briefing on the motion to dismiss. Your
prior post-argument submission, and our opposition thereto,
informed Judge Zobel of the facts regarding the anticipated FDA
approval and addressed the mootness issue. If you wish to make a
joint submission that simply informs the court that the FDA has now
approved the sNDA and has not approved the inclusion on the label
of any claims related to abuse deterrence, we have no objection to
joining in such a limited submission. If that is how you wish to
proceed, please supply a draft for our review. To the extent you
intend, however, to seek leave to file a brief that argues the
purported relevance of this FDA action, please indicate that we do
not consent to your motion.
Jo Ann
From: Hollman, Steven P.
rmailto:steven.hollman(a)hoqanlovells.corn1 Sent; Wednesday,
February 11, 2015 12:45 PM To: Kaplan, Jo Ann (AGO) Cc:
[email protected]: '[email protected]'; Cook, Susan M.;
Gold, Eric (AGO); Kobick, Julia (AGO); McLaughlin, Anne (AGO)
Subject: Zogenix v. Patrick/Supplemental Submission on Regulatory
Developments
Jo Ann,
Your unilateral conclusion that this is "another
non-abuse-deterrent version of Zohydro" is without foundation.
Moreover, the Commonwealth's decision to treat the new formulation
of Zohydro ER differently than a similarly situated drug, Hysingla,
is unconstitutional. Like the new formulation of Zohydro, Hysingla
contains polyethylene oxide and is not currently labeled as abuse
deterrent.
Judge Zobel specifically asked us to let her know when the new
formulation was approved. Our doing so has been delayed a week by
your various questions and ipse dixit pronouncements that the
approval bears no relevance to the pending motion. We plan to file
something shortly; we will state that you oppose.
Steve
Steven Hollman Partner
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Kaplan, Jo Ann (AGO)
From: Kaplan, Jo Ann (AGO) Sent: Monday, February 09, 2015 12:13
PM To: Flollman, Steven P. Cc: [email protected];
'[email protected],; Cook, Susan M.; Gold, Eric (AGO);
Kobick, Julia (AGO); McLaughlin, Anne (AGO) Subject: RE: Zogenix
v. Patrick
Stephen: I immediately responded to your inquiry with my
questions, which remained unanswered until today. The commonwealth
does not needarw/ information from your client, and I never
suggested to the contrary. I was asking, while simultaneously
inquiring of my clients about this matter, whether Zogenix had any
additional information it might want\.o supply us; your response
appears to be no. Since your client therefore relies exclusively on
the mere fact of the FDA sNDA approval, and since that sNDA
approval entails no determination that the new version is any more
abuse-deterrent than the original version, the state regulations
obviously apply to the new version of Zohydro.
You still have not indicated what you perceive to be the
relevance, for purposes of our pending motion, of this FDA approval
of another non-abuse-deterrent version of Zohydro. In the absence
of a response to that inquiry, you have not engaged in any
meaningful consultation with us about your proposed supplemental
filing and we do not consent to any request to file a supplemental
brief. We are certainly aware of no possible relevance to this sNDA
approval,
Jo Ann
From: Hollman, Steven P. [[email protected]] Sent:
Monday, February 09, 2015 10:48 AM To: Kaplan, Jo Ann (AGO) Cc:
Kenneth.Parsigian(a)lw.com; '[email protected]'; Cook, Susan M.;
Gold, Eric (AGO); Kobick, Julia (AGO); McLaughlin, Anne (AGO)
Subject: FW: Zogenix v. Patrick
Jo Ann,
We asked for your position on the new formulation last
Wednesday. The additional materials I supplied over the weekend are
publicly available and frankly should be irrelevant to your
analysis. If the Commonwealth needs access to confidential
information regarding either the new formulation and/or
communications with FDA, that fact alone makes clear that its
conduct interferes with the federal drug approval process and is
preempted.
We have held off our notification of the court for almost a week
now so you could consider our request. We intend to notify the
court of the approval as soon as it reopens. We will indicate that
you have not responded to our request for your position on the
motion for leave to file unless you advise us before then that you
either consent or oppose.
Steve
Steven Holfman Partner
Hogan Loveils US LLP Columbia Square 555 Thirteenth Street, NW
Washington, DC 20004
Tel; +1 202 637 5600
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Direct: +1 202 637 5672 Fax: +1 202 637 5910 Email:
Steven.hollman@hoganiovells,com
www.hoganlovells.com
Please consider the environment before printing this e-mail.
From: Kaplan, JoAnn (AGO) rmailto:ioann.kaplan(a)state.ma.us1
Sent: Monday, February 09, 2015 9:34 AM To: Hollman, Steven P. Cc:
Kenneth.Parsiaian(a)lw.com: 'Steven.Pacini(g)lw.com'; Cook, Susan
M.; Gold, Eric (AGO); Koblck, Julia (AGO); McLaughlin, Anne M (AGO)
Subject: RE: Zogenix v. Patrick
Thanks, Steven. As you may be aware, state offices are closed
today, as is the court. I have accessed this email remotely, but
cannot remotely forward the attachments to my client contacts (who
are presumably not in the office today anyway) and have no ability
to get a decision for you on anything today. As far as I can tell,
the attachments indicate that FDA formed no conclusions of any kind
relative to any abuse-deterrent properties. If you disagree, please
let me know. And either way, I still await your responses to my
additional questions in my email below. Could you also clarify what
you consider to be the relevance of FDA's approval of the sNDA for
purposes of our pending motion?
Thank you.
Jo Ann
From: Hollman, Steven P. [[email protected]] Sent:
Sunday, February 08, 2015 11:46 PM To: Kaplan, Jo Ann (AGO) Cc:
[email protected]: '[email protected]'; Cook, Susan M.;
Gold, Eric (AGO); Kobick, Julia (AGO); McLaughlin, Anne (AGO)
Subject: Zogenix v. Patrick
Jo Ann,
Thank you for your email. Attached, in case you have not pulled
them down yet, are FDA's publicly-available approval letter for the
new formulation, together with the revised labeling. Please let us
know the Commonwealth's position on whether the new formulation is
deemed by Massachusetts to be exempt from the regulation.
Regardless, we plan to notify the court of the FDA approval by
filing a motion for leave to file a supplemental brief. Please let
us know by noon on Monday whether you consent.
Steve
Steven Hollman Partner
Hogan Loveiis US LLP Columbia Square 555 Thirteenth Street, NW
Washington, DC 20004
Tel: +1 202 537 5600 Direct: +1 202 637 5672 Fax: +1 202 637
5910
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Email; steven,[email protected] www.hoganloveils.com
Please consider the environment before printing this e-mail.
From; Kaplan, JoAnn (AGO) [mailto:ioann.kaplan(5)state.ma.us'l
Sent: Wednesday, February 04, 2015 1:44 PM To: Hollman, Steven P.
Cc: Kenneth.Parslglan(5)lw.com; '[email protected]'; Cook, Susan
M.; Gold, Eric (AGO); Kobick, Julia (AGO); McLaughlin, Anne M (AGO)
Subject: RE: Zogenix v, Patrick
Hi Steven. I do not know whether I can have an answer for you
that quickly, but I will try. There does not appear to be any
information available to us on the FDA website relative to the new
formulation/FDA approval except (as you recently indicated would be
the case) that the approval does not permit any claims of
abuse-deterrent properties on the label. Did the FDA form any
conclusion at ail at this stage regarding abuse-deterrence? If so,
would you be able to supply that documentation to us? If not, was
information submitted to the FDA that could potentially demonstrate
to our satisfaction (assuming you were willing to provide it to us)
that the reformulated drug is, in fact, abuse-deterrent?
Also, I note that the company's press release indicates (as the
company has indicated in the past) that it plans to replace the
current formulation with the new formulation in Q2. I had
understood you to say at one point, however, that the original
formulation will remain on the market and continue to be used by
some patients. Is that still the case?
Thank you.
Jo Ann
Jo Ann Shotwell Kaplan Assistant Attorney General Office of the
Attorney General Government Bureau/Administrative Law Division One
Ashburton Place, 20th Floor Boston, Massachusetts 02108
(617)963-2085 Fax: (617) 727-5785 JoAnn.Kaplan(5)5tate.ma.us
From: Hollman, Steven P.
[mailto:steven.hollman(5)hoganlovells.com1 Sent; Wednesday,
February 04, 2015 1:07 PM To: Kaplan, Jo Ann (AGO) Cc;
Kenneth.ParsigianPlw.com: '[email protected]'; Cook, Susan M.;
Gold, Eric (AGO); Kobick, Julia (AGO); McLaughlin, Anne (AGO)
Subject: Zogenix v. Patrick
Jo Ann,
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As you may know, FDA recently approved a new formulation of
Zohydro ER that contains BeadTek, which is designed to provide
abuse-deterrent properties. Please let us know promptly whether
Massachusetts takes the position that the challenged BORIP, BOROPA,
and BORIM regulations apply to this new formulation.
We intend to advise the court of the recent regulatory approval
as promptly as possible. Accordingly, we would like to hear back
from you on this issue by the close of business tomorrow.
Regards,
Steven Hollman Partner Hogan Lovells US LLP Columbia Square 555
Thirteenth Street, NW Washington, DC 20004 Tel; +1 202 637 5600
Direct: +1202 637 5672 Fax: +1 202 637 5910 Email;
Steven.hollman(5)hoeanlovells.com
www.hoganlovells.com Please consider the environment before
printing this e-mail.
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practice that includes Hogan Lovells US LLP and Hogan Lovells
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