Michael L. Babich: Final Debarment Order, 76084-76085 [2020-26226]
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Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1347]
Michael L. Babich: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
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 L.
Babich 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. Babich 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.
Babich 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
September 2, 2020 (30 days after receipt
of the notice), Mr. Babich had not
responded. Mr. Babich’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
November 27, 2020.
ADDRESSES: Submit applications for
special termination of debarment to
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852, 240–402–7500, or at
www.regulations.gov.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of
Enforcement, Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, debarments@
fda.hhs.gov, or at 240–402–8743.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
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 22, 2020, Mr. Babich was
convicted as defined in section 306(l)(1)
VerDate Sep<11>2014
19:29 Nov 25, 2020
Jkt 253001
of the FD&C Act when judgment was
entered against him in the U.S. District
Court for the District of Massachusetts,
after his plea of guilty, to one count of
conspiracy in violation of 18 U.S.C. 371
and one count of wire fraud in violation
of 18 U.S.C. 1341.
The factual basis for this conviction is
as follows: Mr. Babich was the President
and Chief Executive Officer 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 May 2012 and continuing until
December 2015, Mr. Babich conspired
with other employees of Insys to bribe
and provide kickbacks, often mailed
through the U.S. Postal service, to
medical practitioners in various states to
get those practitioners to increase
prescribing SUBSYS to their patients,
many of whom did not have cancer. The
bribes and kickbacks took various forms,
including honoraria for the
practitioners’ participation in
educational events and payment of the
practitioner’s staff salaries. To further
this conspiracy, Mr. Babich along with
his co-conspirators devised a scheme
whereby Insys executives conspired to
mislead and defraud health insurance
providers to ensure those providers
approved payment for SUBSYS when it
was prescribed for non-cancer patients.
As a result of this conviction FDA
sent Mr. Babich, by certified mail on
July 16, 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.
Babich 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.
Babich 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 action. Mr.
Babich received the proposal on August
3, 2020. Mr. Babich did not request a
hearing within the timeframe prescribed
by regulation and has, therefore, waived
his opportunity for a hearing and any
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Fmt 4703
Sfmt 4703
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. Babich
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. Babich 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 306(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.
Babich, 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.
Babich 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. Babich 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, 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. Babich for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2020–N–1347 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.
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Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices
Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26226 Filed 11–25–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–4437]
In-Use Stability Studies and
Associated Labeling Statements for
Multiple-Dose Injectable Animal Drug
Products; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry (GFI) #242
entitled ‘‘In-Use Stability Studies and
Associated Labeling Statements for
Multiple-Dose Injectable Animal Drug
Products.’’ The purpose of in-use
stability testing is to establish a period
of time during which a multiple-dose
drug product may be used while
retaining acceptable quality
specifications once the container is
opened (e.g., after a container has been
needle-punctured). This guidance
reflects the Agency’s current thinking
on how to formulate in-use statements,
as well as how to design and carry out
in-use stability studies to support these
in-use statements, for multiple-dose
injectable drug products intended for
use in animals. This current thinking
pertains to both generic drug products
and pioneer drug products regardless of
whether the pioneer reference listed
new animal drug (RLNAD) currently has
an in-use statement on the labeling.
DATES: The announcement of the
guidance is published in the Federal
Register on November 27, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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://
www.regulations.gov will be posted to
the docket unchanged. Because your
VerDate Sep<11>2014
19:29 Nov 25, 2020
Jkt 253001
comment will be made public, you are
solely responsible for ensuring that your
comment 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. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–4437 for ‘‘In-Use Stability
Studies and Associated Labeling
Statements for Multiple-Dose Injectable
Animal Drug Products.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ 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.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. 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 comments. 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. Submit
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76085
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Kevin Rice, Center for Veterinary
Medicine (HFV–140), Food and Drug
Administration, 7500 Standish Place,
Rockville, MD 20855, 240–402–0680,
kevin.rice@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 4,
2017 (82 FR 851), FDA published the
notice of availability for a draft GFI #242
entitled ‘‘In-Use Stability Studies and
Associated Labeling Statements for
Multiple-Dose Injectable Animal Drug
Products.’’ The purpose of in-use
stability testing is to establish a period
of time during which a multiple-dose
drug product may be used while
retaining acceptable quality
specifications once the container is
opened (e.g., after a container has been
needle-punctured).
FDA received two comments on the
draft guidance and those comments
were considered as the guidance was
E:\FR\FM\27NON1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Pages 76084-76085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26226]
[[Page 76084]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1347]
Michael L. Babich: 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 L. Babich 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. Babich 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. Babich 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
September 2, 2020 (30 days after receipt of the notice), Mr. Babich had
not responded. Mr. Babich'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 November 27, 2020.
ADDRESSES: Submit applications for special termination of debarment to
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857, [email protected], or at 240-
402-8743.
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 22, 2020, Mr. Babich 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 his plea of guilty, to one count of conspiracy in
violation of 18 U.S.C. 371 and one count of wire fraud in violation of
18 U.S.C. 1341.
The factual basis for this conviction is as follows: Mr. Babich was
the President and Chief Executive Officer 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 May 2012 and
continuing until December 2015, Mr. Babich conspired with other
employees of Insys to bribe and provide kickbacks, often mailed through
the U.S. Postal service, to medical practitioners in various states to
get those practitioners to increase prescribing SUBSYS to their
patients, many of whom did not have cancer. The bribes and kickbacks
took various forms, including honoraria for the practitioners'
participation in educational events and payment of the practitioner's
staff salaries. To further this conspiracy, Mr. Babich along with his
co-conspirators devised a scheme whereby Insys executives conspired to
mislead and defraud health insurance providers to ensure those
providers approved payment for SUBSYS when it was prescribed for non-
cancer patients.
As a result of this conviction FDA sent Mr. Babich, by certified
mail on July 16, 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. Babich 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. Babich 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 action. Mr. Babich received the
proposal on August 3, 2020. Mr. Babich 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.
Babich 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. Babich 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 306(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. Babich, 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. Babich 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. Babich 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, 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. Babich for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2020-N-1347 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.
[[Page 76085]]
Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26226 Filed 11-25-20; 8:45 am]
BILLING CODE 4164-01-P
