Kim C. Hendrick: Debarment Order, 38656-38657 [E9-18621]
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38656
Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
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Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–18533Filed 8–3–09; 8:45 am]
mstockstill on DSKH9S0YB1PROD with NOTICES
III. Paper Application, Registration,
and Submission Information
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Nov<24>2008
16:07 Aug 03, 2009
Jkt 217001
Food and Drug Administration
[Docket No. FDA–2008–N–0582]
Kim C. Hendrick: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the act) permanently
debarring Kim C. Hendrick, M.D., from
providing services in any capacity to a
person that has an approved or pending
drug product application. We base this
order on a finding that Dr. Hendrick was
convicted of a felony under Federal law
for conduct relating to the development
or approval, including the process for
development or approval, of a drug
product, and for conduct otherwise
relating to the regulation of a drug
product under the act. After being given
notice of the proposed permanent
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation, Dr. Hendrick
failed to request a hearing. Dr.
Hendrick’s failure to request a hearing
constitutes a waiver of his right to a
hearing concerning this action.
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
DATES:
This order is effective August 4,
2009.
ADDRESSES: Submit applications for
special termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Robert Hummel, Sr., Division of
Compliance Policy (HFC–230), Office of
Enforcement, Office of Regulatory
Affairs, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 240–632–6845.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) of the act (21
U.S.C. 335a(a)(2)(A)) requires debarment
of an individual if FDA finds that the
individual has been convicted of a
felony under Federal law for conduct
relating to the development or approval,
including the process for development
or approval, of any drug product.
Section 306(a)(2)(B) of the act requires
debarment of an individual if FDA finds
that the individual has been convicted
of a felony under Federal law for
conduct otherwise relating to the
regulation of any drug product under
the act.
On September 11, 2007, the U.S.
District Court for the Eastern District of
Michigan accepted Dr. Hendrick’s guilty
plea and entered judgment against him
for one count of mail fraud, a federal
felony offense under 18 U.S.C. 1341.
This offense was committed when Dr.
Hendrick was a licensed physician
practicing medicine in the State of
Michigan. Dr. Hendrick agreed to
participate in the clinical research trial
for Augmentin XR, including its use in
the treatment of adults with Acute
Bacterial Sinusitis (ABS). As part of his
participation in the clinical study, he
agreed to conduct the study in
conformity with the protocol
established by GlaxoSmithKline and to
comply with FDA regulations. He also
agreed to take X-rays, before and after
treatment, of persons he diagnosed with
ABS, and to have an independent
radiologist analyze these and issue
reports regarding the X-rays.
Dr. Hendrick admitted that instead of
having an independent radiologist
review the X-rays and issue reports, he
allowed certain X-rays to be sent in
batch form, which was a direct violation
of the protocol. Further, he did not
verify the purported signatures of the
independent radiologist reports and,
instead, failed to disclose to
GlaxoSmithKline and/or FDA that the
signatures were unverified and possibly
E:\FR\FM\04AUN1.SGM
04AUN1
Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
forged, with the intent to create a false
impression of a state of facts. Dr.
Hendrick was paid by GlaxoSmithKline
approximately $116,800 in X-ray fees
for his participation in the clinical
research trial. In so doing he caused a
check to be mailed to him through the
Postal Service at the direction of
GlaxoSmithKline as partial payment for
his participation in the clinical trial for
the purpose of executing the scheme to
defraud.
As a result of this conviction, FDA
sent Dr. Hendrick by certified mail on
May 4, 2009, 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)(A) and (a)(2)(B) of the act, that
Dr. Hendrick was convicted of a felony
under Federal law for conduct relating
to the development or approval of a
drug product, including the process for
development or approval of a drug
product, and conduct otherwise relating
to the regulation of a drug product
under the act. The proposal also offered
Dr. Hendrick 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
a waiver of the opportunity for a hearing
and of any contentions concerning this
action. Dr. Hendrick did not request a
hearing 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 Acting Director, Office
of Enforcement, Office of Regulatory
Affairs, under section 306(a)(2)(A) and
(a)(2)(B) of the act, and under authority
delegated to the Acting Director (Staff
Manual Guide 1410.35), finds that Dr.
Hendrick has been convicted of a felony
under Federal law for conduct relating
to the development or approval of a
drug product, including the process for
development or approval, of a drug
product, and conduct otherwise relating
to the regulation of a drug product
under the act.
As a result of the foregoing finding,
Dr. Hendrick is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application under
sections 505, 512, or 802 of the act (21
U.S.C. 355, 360b, or 382), or under
section 351 of the Public Health Service
Act (42 U.S.C. 262), effective (see DATES)
(see sections 306(c)(1)(B) and
(c)(2)(A)(ii) and 201(dd) of the act (21
U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii),
VerDate Nov<24>2008
16:07 Aug 03, 2009
Jkt 217001
and 321(dd)). 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 Dr.
Hendrick, in any capacity, during Dr.
Hendrick’s permanent debarment, will
be subject to civil money penalties
(section 307(a)(6) of the act (21 U.S.C.
335b(a)(6))). If Dr. Hendrick, during his
period of debarment, provides services
in any capacity to a person with an
approved or pending drug product
application, he will be subject to civil
money penalties (section 307(a)(7) of the
act). In addition, FDA will not accept or
review any abbreviated new drug
applications submitted by or with the
assistance of Dr. Hendrick during his
permanent debarment (section
306(c)(1)(B) of the act).
Any application by Dr. Hendrick for
special termination of debarment under
section 306(d)(4) of the act should be
identified with Docket No. FDA–2008–
N–0582 and sent to the Division of
Dockets Management (see ADDRESSES).
All such submissions are to be filed in
four copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20(j).
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: July 15, 2009.
Alyson L. Saben,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. E9–18621 Filed 8–3–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–N–0501]
Paul H. Kornak: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the act) permanently
debarring Paul H. Kornak 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 Paul H.
Kornak was convicted of three felonies
under Federal law for conduct relating
to the development or approval,
including the process for development
or approval, of a drug product, and for
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
38657
conduct otherwise relating to the
regulation of a drug product under the
act. After being given notice of the
proposed permanent debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation,
Mr. Kornak failed to request a hearing.
Mr. Kornak’s failure to request a hearing
constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is effective August 4,
2009.
ADDRESSES: Submit applications for
special termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Robert L. Hummel, Sr., Division of
Compliance Policy (HFC–230), Office of
Enforcement, Office of Regulatory
Affairs, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 240–632–6845.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) of the act (21
U.S.C. 335a(a)(2)(A)) requires debarment
of an individual if FDA finds that the
individual has been convicted of a
felony under Federal law for conduct
relating to the development or approval,
including the process for development
or approval, of any drug product.
Section 306(a)(2)(B) of the act requires
debarment of an individual if FDA finds
that the individual has been convicted
of a felony under Federal law for
conduct otherwise relating to the
regulation of any drug product under
the act.
On January 18, 2005, the U.S. District
Court for the Northern District of New
York accepted Mr. Kornak’s plea of
guilty and entered judgment against Mr.
Kornak for one count of making and
using a materially false statement, one
count of mail fraud, and one count of
criminally negligent homicide, federal
felony offenses under 18 U.S.C.
1001(a)(3), 1341 and 1346, and 13,
respectively. The actions underlying
these convictions were committed while
Mr. Kornak was employed by the
Department of Veterans Affairs as the
coordinator of several clinical studies of
drug products. Mr. Kornak participated
in a scheme to defraud the sponsors of
these studies by repeatedly submitting
false documentation and enrolling and
causing to be enrolled persons as study
subjects who did not qualify under
particular study protocols. Mr. Kornak
admitted to submitting a case report
form with regard to a study subject
knowing the document contained
E:\FR\FM\04AUN1.SGM
04AUN1
Agencies
[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38656-38657]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18621]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0582]
Kim C. Hendrick: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the act) permanently
debarring Kim C. Hendrick, M.D., from providing services in any
capacity to a person that has an approved or pending drug product
application. We base this order on a finding that Dr. Hendrick was
convicted of a felony under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of a drug product, and for conduct otherwise relating to the
regulation of a drug product under the act. After being given notice of
the proposed permanent debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation, Dr. Hendrick
failed to request a hearing. Dr. Hendrick's failure to request a
hearing constitutes a waiver of his right to a hearing concerning this
action.
DATES: This order is effective August 4, 2009.
ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Robert Hummel, Sr., Division of
Compliance Policy (HFC-230), Office of Enforcement, Office of
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240-632-6845.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) of the act (21 U.S.C. 335a(a)(2)(A)) requires
debarment of an individual if FDA finds that the individual has been
convicted of a felony under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of any drug product. Section 306(a)(2)(B) of the act requires
debarment of an individual if FDA finds that the individual has been
convicted of a felony under Federal law for conduct otherwise relating
to the regulation of any drug product under the act.
On September 11, 2007, the U.S. District Court for the Eastern
District of Michigan accepted Dr. Hendrick's guilty plea and entered
judgment against him for one count of mail fraud, a federal felony
offense under 18 U.S.C. 1341. This offense was committed when Dr.
Hendrick was a licensed physician practicing medicine in the State of
Michigan. Dr. Hendrick agreed to participate in the clinical research
trial for Augmentin XR, including its use in the treatment of adults
with Acute Bacterial Sinusitis (ABS). As part of his participation in
the clinical study, he agreed to conduct the study in conformity with
the protocol established by GlaxoSmithKline and to comply with FDA
regulations. He also agreed to take X-rays, before and after treatment,
of persons he diagnosed with ABS, and to have an independent
radiologist analyze these and issue reports regarding the X-rays.
Dr. Hendrick admitted that instead of having an independent
radiologist review the X-rays and issue reports, he allowed certain X-
rays to be sent in batch form, which was a direct violation of the
protocol. Further, he did not verify the purported signatures of the
independent radiologist reports and, instead, failed to disclose to
GlaxoSmithKline and/or FDA that the signatures were unverified and
possibly
[[Page 38657]]
forged, with the intent to create a false impression of a state of
facts. Dr. Hendrick was paid by GlaxoSmithKline approximately $116,800
in X-ray fees for his participation in the clinical research trial. In
so doing he caused a check to be mailed to him through the Postal
Service at the direction of GlaxoSmithKline as partial payment for his
participation in the clinical trial for the purpose of executing the
scheme to defraud.
As a result of this conviction, FDA sent Dr. Hendrick by certified
mail on May 4, 2009, 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)(A) and (a)(2)(B) of the act, that Dr. Hendrick
was convicted of a felony under Federal law for conduct relating to the
development or approval of a drug product, including the process for
development or approval of a drug product, and conduct otherwise
relating to the regulation of a drug product under the act. The
proposal also offered Dr. Hendrick 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 a waiver of the opportunity for a hearing and of any
contentions concerning this action. Dr. Hendrick did not request a
hearing 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 Acting Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(a)(2)(A) and (a)(2)(B) of the
act, and under authority delegated to the Acting Director (Staff Manual
Guide 1410.35), finds that Dr. Hendrick has been convicted of a felony
under Federal law for conduct relating to the development or approval
of a drug product, including the process for development or approval,
of a drug product, and conduct otherwise relating to the regulation of
a drug product under the act.
As a result of the foregoing finding, Dr. Hendrick is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351
of the Public Health Service Act (42 U.S.C. 262), effective (see DATES)
(see sections 306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the act (21
U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii), and 321(dd)). 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 Dr. Hendrick, in any capacity, during Dr. Hendrick's
permanent debarment, will be subject to civil money penalties (section
307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Dr. Hendrick, during
his period of debarment, provides services in any capacity to a person
with an approved or pending drug product application, he will be
subject to civil money penalties (section 307(a)(7) of the act). In
addition, FDA will not accept or review any abbreviated new drug
applications submitted by or with the assistance of Dr. Hendrick during
his permanent debarment (section 306(c)(1)(B) of the act).
Any application by Dr. Hendrick for special termination of
debarment under section 306(d)(4) of the act should be identified with
Docket No. FDA-2008-N-0582 and sent to the Division of Dockets
Management (see ADDRESSES). All such submissions are to be filed in
four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20(j).
Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: July 15, 2009.
Alyson L. Saben,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. E9-18621 Filed 8-3-09; 8:45 am]
BILLING CODE 4160-01-S