[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38656-38657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18621]


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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.

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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]
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