Michael Gurry: Final Debarment Order, 12473-12474 [2021-04374]
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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
(the Commissioner) on the Center
Director’s proposal to refuse to approve
NDA 210934. If Lexicon decides to seek
a hearing, it must file: (1) A written
notice of participation and request for a
hearing (see the DATES section) and (2)
the studies, data, information, and
analyses relied upon to justify a hearing
(see the DATES section), as specified in
§ 314.200 (21 CFR 314.200).
As stated in § 314.200(g), a request for
a hearing may not rest upon allegations
or denials, but must present specific
facts showing that there is a genuine
and substantial issue of fact that
requires a hearing to resolve. We note in
this regard that because CDER proposes
to refuse to approve NDA 210934 based
on the multiple deficiencies
summarized above, any hearing request
from Lexicon must address all of those
deficiencies. Failure to request a hearing
within the time provided and in the
manner required by § 314.200
constitutes a waiver of the opportunity
to request a hearing. If a hearing request
is not properly submitted, FDA will
issue a notice refusing to approve NDA
210934.
The Commissioner will grant a
hearing if there exists a genuine and
substantial issue of fact or if the
Commissioner concludes that a hearing
would otherwise be in the public
interest (§ 314.200(g)(6)). If a hearing is
granted, it will be conducted according
to the procedures provided in 21 CFR
parts 10 through 16 (21 CFR 314.201).
Paper submissions under this notice
of opportunity for a hearing should be
filed in one copy. Except for data and
information prohibited from public
disclosure under 21 U.S.C. 331(j) or 18
U.S.C. 1905, submissions may be seen
in the Dockets Management Staff Office
between 9 a.m. and 4 p.m., Monday
through Friday, and on the internet at
https://www.regulations.gov. This notice
is issued under section 505(c)(1)(B) of
the FD&C Act and §§ 314.110(b)(3) and
314.200.
Dated: February 25, 2021.
Patrizia Cavazzoni,
Acting Director, Center for Drug Evaluation
and Research.
[FR Doc. 2021–04342 Filed 3–2–21; 8:45 am]
BILLING CODE 4164–01–P
jbell on DSKJLSW7X2PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1413]
Michael Gurry: Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:29 Mar 02, 2021
Jkt 253001
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Michael
Gurry from providing services in any
capacity to a person that has an
approved or pending drug product
application. FDA bases this order on a
finding that Mr. Gurry was convicted of
a felony under Federal law for conduct
that relates to the regulation of a drug
product under the FD&C Act. Mr. Gurry
was given notice of the proposed
permanent debarment and an
opportunity to request a hearing to show
why he should not be debarred. As of
October 22, 2020 (30 days after receipt
of the notice), Mr. Gurry had not
responded. Mr. Gurry’s failure to
respond and request a hearing
constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is applicable March 8,
2021.
ADDRESSES: Submit applications for
termination of debarment to the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240–402–
7500, or at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa (ELEM–4029) Division
of Enforcement, Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Drive,
Rockville, MD 20857, 240–402–8743,
debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) requires
debarment of an individual from
providing services in any capacity to a
person that has an approved or pending
drug product application if FDA finds
that the individual has been convicted
of a felony under Federal law for
conduct relating to the regulation of any
drug product under the FD&C Act. On
January 13, 2020, Mr. Gurry was
convicted as defined in section 306(l)(1)
of the FD&C Act when judgment was
entered against him in the U.S. District
Court for the District of Massachusetts,
after a jury verdict, on one count of
racketeering conspiracy in violation of
18 U.S.C. 1962(d). The pattern of
racketeering activity he was convicted
of included engaging in multiple acts of
mail fraud (18 U.S.C. 1341) and wire
fraud (18 U.S.C. 1343).
The factual basis for this conviction is
as follows: Mr. Gurry held executive
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
12473
management positions, to include Vice
President of Managed Markets, of Insys
Therapeutics Inc. (Insys), a Delaware
Corporation, with headquarters in
Chandler, Arizona. Insys developed and
owned a drug called SUBSYS, a liquid
formulation of fentanyl to be applied
under the tongue. FDA approved
SUBSYS for the management of
breakthrough pain in adult cancer
patients who are already receiving and
are already tolerant to opioid therapy for
their underlying persistent cancer pain.
From early 2012 and continuing through
2015, Mr. Gurry participated in a
conspiracy whereby employees of Insys
bribed medical practitioners in various
states to get those practitioners to
increase prescribing SUBSYS to their
patients, many of whom did not have
cancer. Mr. Gurry, along with his
coconspirators, measured the effect of
these bribes on each practitioner’s
prescribing habits and on the revenue
that each bribed practitioner generated
for Insys. Mr. Gurry, along with his
coconspirators, reduced or eliminated
bribes paid to those practitioners who
failed to meet the minimum
prescription requirements or failed to
generate enough revenue to justify
additional bribes. To further this
conspiracy, Mr. Gurry and his
coconspirators misled and defrauded
health insurance providers to ensure
those providers approved payment for
SUBSYS. Insys achieved this goal by
establishing the ‘‘Insys Reimbursement
Center’’, which was designed to shift the
burden of seeking prior authorization
for SUBSYS from practitioners to Insys.
This allowed Insys to determine what
medical information was presented to
insurers. Mr. Gurry and his
coconspirators directed Insys employees
to mislead insurers to obtain payment
authorization.
As a result of this conviction, FDA
sent Mr. Gurry, by United Parcel
Service, on September 21, 2020, a notice
proposing to permanently debar him
from providing services in any capacity
to a person that has an approved or
pending drug product application. The
proposal was based on a finding, under
section 306(a)(2)(B) of the FD&C Act,
that Mr. Gurry was convicted of a felony
under Federal law for conduct relating
to the regulation of a drug product
under the FD&C Act. The proposal also
offered Mr. Gurry an opportunity to
request a hearing, providing him 30
days from the date of receipt of the letter
in which to file the request, and advised
him that failure to request a hearing
constituted an election not to use the
opportunity for a hearing and a waiver
of any contentions concerning this
E:\FR\FM\03MRN1.SGM
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12474
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
action. Mr. Gurry received the proposal
on September 22, 2020. He did not
request a hearing within the timeframe
prescribed by regulation and has,
therefore, waived his opportunity for a
hearing and any contentions concerning
his debarment (21 CFR part 12).
jbell on DSKJLSW7X2PROD with NOTICES
II. Findings and Order
17:29 Mar 02, 2021
Dated: February 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04374 Filed 3–2–21; 8:45 am]
BILLING CODE 4164–01–P
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Gurry has
been convicted of a felony under
Federal law for conduct otherwise
relating to the regulation of a drug
product under the FD&C Act.
As a result of the foregoing finding,
Mr. Gurry is permanently debarred from
providing services in any capacity to a
person with an approved or pending
drug product application, effective (see
DATES) (see sections 306(a)(2)(B) and
(c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending
drug product application who
knowingly employs or retains as a
consultant or contractor, or otherwise
uses the services of Mr. Gurry in any
capacity during his debarment, will be
subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C.
335b(a)(6))). If Mr. Gurry provides
services in any capacity to a person with
an approved or pending drug product
application during his period of
debarment, he will be subject to civil
money penalties (section 307(a)(7) of the
FD&C Act). In addition, FDA will not
accept or review any abbreviated new
drug application from Mr. Gurry during
his period of debarment, other than in
connection with an audit under section
306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act). Note that,
for purposes of section 306 of the FD&C
Act, a ‘‘drug product’’ is defined as a
drug subject to regulation under section
505, 512, or 802 of the FD&C Act (21
U.S.C. 355, 360b, or 382) or under
section 351 of the Public Health Service
Act (42 U.S.C. 262) (section 201(dd) of
the FD&C Act (21 U.S.C. 321(dd))).
Any application by Mr. Gurry for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2020–N–1413 and sent to the
Dockets Management Staff (see
ADDRESSES). The public availability of
information in these submissions is
governed by 21 CFR 10.20.
Publicly available submissions will be
placed in the docket and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff (see
VerDate Sep<11>2014
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0104]
PolyMedica Industries Inc., et al.;
Proposal To Withdraw Approval of
Three New Drug Applications;
Opportunity for a Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is proposing to withdraw
approval of three new drug applications
(NDAs) and is announcing an
opportunity for the NDA holders to
request a hearing on this proposal. The
basis for the proposal is that the NDA
holders have repeatedly failed to file
required annual reports for those NDAs.
DATES: The NDA holders may submit a
request for a hearing by April 2, 2021.
Submit all data, information, and
analyses upon which the request for a
hearing relies by May 3, 2021. Submit
electronic or written comments by May
3, 2021.
ADDRESSES: The request for a hearing
may be submitted by the NDA holders
by either of the following methods:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments to
submit your request for a hearing.
Comments submitted electronically to
https://www.regulations.gov, including
any attachments to the request for a
hearing, will be posted to the docket
unchanged.
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
• Because your request for a hearing
will be made public, you are solely
responsible for ensuring that your
request does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. The request
for a hearing must include the Docket
No. FDA–2021–N–0104 for
‘‘PolyMedica Industries Inc. et al.;
Proposal to Withdraw Approval of
Three New Drug Applications;
Opportunity for a Hearing.’’ The request
for a hearing will be placed in the
docket and publicly viewable at https://
www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4
p.m., Monday through Friday, 240–402–
7500.
The NDA holders may submit all data
and analyses upon which the request for
a hearing relies in the same manner as
the request for a hearing except as
follows:
• Confidential Submissions—To
submit any data analyses with
confidential information that you do not
wish to be made publicly available,
submit your data and analyses only as
a written/paper submission. You should
submit two copies total of all data and
analyses. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of any decisions on
this matter. The second copy, which
will have the claimed confidential
information redacted/blacked out, will
be available for public viewing and
posted on https://www.regulations.gov
or available at the Dockets Management
Staff between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Submit both copies to the Dockets
Management Staff. Any information
marked as ‘‘confidential’’ will not be
disclosed except in accordance with 21
CFR 10.20 and other applicable
disclosure law.
Comments Submitted by Other
Interested Parties: For all comments
submitted by other interested parties,
submit comments as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
E:\FR\FM\03MRN1.SGM
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Agencies
[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Pages 12473-12474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04374]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1413]
Michael Gurry: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
permanently debarring Michael Gurry from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Mr. Gurry was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Mr. Gurry was given
notice of the proposed permanent debarment and an opportunity to
request a hearing to show why he should not be debarred. As of October
22, 2020 (30 days after receipt of the notice), Mr. Gurry had not
responded. Mr. Gurry's failure to respond and request a hearing
constitutes a waiver of his right to a hearing concerning this action.
DATES: This order is applicable March 8, 2021.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa (ELEM-4029) Division of
Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Drive, Rockville, MD 20857, 240-402-8743,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual from providing services in any
capacity to a person that has an approved or pending drug product
application if FDA finds that the individual has been convicted of a
felony under Federal law for conduct relating to the regulation of any
drug product under the FD&C Act. On January 13, 2020, Mr. Gurry was
convicted as defined in section 306(l)(1) of the FD&C Act when judgment
was entered against him in the U.S. District Court for the District of
Massachusetts, after a jury verdict, on one count of racketeering
conspiracy in violation of 18 U.S.C. 1962(d). The pattern of
racketeering activity he was convicted of included engaging in multiple
acts of mail fraud (18 U.S.C. 1341) and wire fraud (18 U.S.C. 1343).
The factual basis for this conviction is as follows: Mr. Gurry held
executive management positions, to include Vice President of Managed
Markets, of Insys Therapeutics Inc. (Insys), a Delaware Corporation,
with headquarters in Chandler, Arizona. Insys developed and owned a
drug called SUBSYS, a liquid formulation of fentanyl to be applied
under the tongue. FDA approved SUBSYS for the management of
breakthrough pain in adult cancer patients who are already receiving
and are already tolerant to opioid therapy for their underlying
persistent cancer pain. From early 2012 and continuing through 2015,
Mr. Gurry participated in a conspiracy whereby employees of Insys
bribed medical practitioners in various states to get those
practitioners to increase prescribing SUBSYS to their patients, many of
whom did not have cancer. Mr. Gurry, along with his coconspirators,
measured the effect of these bribes on each practitioner's prescribing
habits and on the revenue that each bribed practitioner generated for
Insys. Mr. Gurry, along with his coconspirators, reduced or eliminated
bribes paid to those practitioners who failed to meet the minimum
prescription requirements or failed to generate enough revenue to
justify additional bribes. To further this conspiracy, Mr. Gurry and
his coconspirators misled and defrauded health insurance providers to
ensure those providers approved payment for SUBSYS. Insys achieved this
goal by establishing the ``Insys Reimbursement Center'', which was
designed to shift the burden of seeking prior authorization for SUBSYS
from practitioners to Insys. This allowed Insys to determine what
medical information was presented to insurers. Mr. Gurry and his
coconspirators directed Insys employees to mislead insurers to obtain
payment authorization.
As a result of this conviction, FDA sent Mr. Gurry, by United
Parcel Service, on September 21, 2020, a notice proposing to
permanently debar him from providing services in any capacity to a
person that has an approved or pending drug product application. The
proposal was based on a finding, under section 306(a)(2)(B) of the FD&C
Act, that Mr. Gurry was convicted of a felony under Federal law for
conduct relating to the regulation of a drug product under the FD&C
Act. The proposal also offered Mr. Gurry an opportunity to request a
hearing, providing him 30 days from the date of receipt of the letter
in which to file the request, and advised him that failure to request a
hearing constituted an election not to use the opportunity for a
hearing and a waiver of any contentions concerning this
[[Page 12474]]
action. Mr. Gurry received the proposal on September 22, 2020. He did
not request a hearing within the timeframe prescribed by regulation and
has, therefore, waived his opportunity for a hearing and any
contentions concerning his debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr. Gurry
has been convicted of a felony under Federal law for conduct otherwise
relating to the regulation of a drug product under the FD&C Act.
As a result of the foregoing finding, Mr. Gurry is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(B) and (c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Mr. Gurry in any capacity during his
debarment, will be subject to civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Gurry provides services
in any capacity to a person with an approved or pending drug product
application during his period of debarment, he will be subject to civil
money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA
will not accept or review any abbreviated new drug application from Mr.
Gurry during his period of debarment, other than in connection with an
audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the
FD&C Act). Note that, for purposes of section 306 of the FD&C Act, a
``drug product'' is defined as a drug subject to regulation under
section 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382)
or under section 351 of the Public Health Service Act (42 U.S.C. 262)
(section 201(dd) of the FD&C Act (21 U.S.C. 321(dd))).
Any application by Mr. Gurry for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2020-N-1413 and sent to the Dockets Management Staff
(see ADDRESSES). The public availability of information in these
submissions is governed by 21 CFR 10.20.
Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday, 240-402-7500.
Dated: February 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04374 Filed 3-2-21; 8:45 am]
BILLING CODE 4164-01-P