[Federal Register Volume 77, Number 131 (Monday, July 9, 2012)]
[Notices]
[Pages 40366-40367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16600]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0860]


Glen R. Justice: 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 FD&C Act) debarring 
Glen R. Justice, M.D. from providing services in any capacity to a 
person that has an approved or pending drug product application for a 
period of 25 years. We base this order on a finding that Dr. Justice 
was convicted of five felony counts under Federal law for conduct 
involving health care fraud and that this pattern of conduct was 
sufficient to find that there is reason to believe he may violate 
requirements under the FD&C Act relating to drug products. Dr. Justice 
was given notice of the proposed debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Dr. 
Justice failed to respond. Dr. Justice's failure to respond constitutes 
a waiver of his right to a hearing concerning this action.

DATES: This order is effective July 9, 2012.

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: Kenny Shade, Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, 
MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(b)(2)(B)(ii)(I) of the FD&C Act (21 U.S.C. 
335a(b)(2)(B)(ii)(I)) permits debarment of an individual if FDA finds 
that the individual has been convicted of a felony under Federal law 
for conduct which involves bribery, payment of illegal gratuities, 
fraud, perjury, false statement, racketeering, blackmail, extortion, 
falsification or destruction of records, or interference with, 
obstruction of an investigation into, or prosecution of any criminal 
offense, and it finds, on the basis of the conviction and other 
information, that such individual has demonstrated a pattern of conduct 
sufficient to find that there is reason to believe the individual may 
violate requirements under the FD&C Act relating to drug products.
    On July 25, 2011, the U.S. District Court for the Central District 
of California entered judgment against Dr. Justice for health care 
fraud in violation of 18 U.S.C. 1347, and aiding and abetting and 
causing an act to be done in violation of 18 U.S.C. 2.
    The FDA's finding that debarment is appropriate is based on the 
felony convictions referenced herein. The factual basis for this 
conviction is as follows: Dr. Justice was a physician licensed by the 
State of California. Dr. Justice owned and operated a medical practice 
in the Central District of California and he enrolled as a provider 
with federally-funded and private health care programs.
    Dr. Justice devised and executed a scheme to defraud federally-
funded and private health care benefit programs. As part of the scheme, 
Dr. Justice knowingly and willfully submitted, and caused to be 
submitted, false and fraudulent claims to health care benefit programs 
for injectable medications, knowing that those medications were never 
provided to the patients and he billed patients health care benefit 
programs for more expensive injectable medications when less expensive 
medications were provided. Dr. Justice continued his conduct despite 
being advised by staff to desist and subsequent to the execution of a 
search warrant at his medical practice in 2006. As a result of Dr. 
Justice's fraudulent business practices, health care benefit programs 
suffered losses between $400,000 and $1,000,000.
    As a result of his convictions, on March 26, 2012, FDA sent Dr. 
Justice a notice by certified mail proposing to debar him for 25 years 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
the finding, under section 306(b)(2)(B)(ii)(I) of the FD&C Act, that 
Dr. Justice was convicted of felonies under Federal law for conduct 
which involved health care fraud, and that the Agency found, on the 
basis of the conviction and other information, that Dr. Justice had 
demonstrated a pattern of conduct sufficient to find that there is 
reason to believe he may violate

[[Page 40367]]

requirements under the FD&C Act relating to drug products. This 
conclusion was based on the fact that Dr. Justice had legal and 
professional obligations to ensure that he submitted accurate medical 
claims for procedures he performed, as well as administering medicines 
that were appropriate for his patients' condition, which he knowingly 
and willingly disregarded, as well as the fact that Dr. Justice 
intentionally billed for different FDA-regulated drug products than 
what he wrote prescriptions for. Therefore, FDA had reason to believe 
that, if Dr. Justice were to provide services to a person that has an 
approved or pending drug application, he may violate requirements under 
the FD&C Act relating to drug products. The proposal offered Dr. 
Justice 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. The proposal was received on March 29, 2012. Dr. Justice failed 
to respond within the timeframe prescribed by regulation and has, 
therefore, waived his opportunity for a hearing and has waived any 
contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(b)(2)(B)(ii)(I) of the FD&C Act, 
under authority delegated to the Director (Staff Manual Guide 1410.35), 
finds that Glen R. Justice has been convicted of five counts of a 
felony under Federal law for conduct involving health care fraud, and, 
on the basis of the conviction and other information, finds that Dr. 
Justice has demonstrated a pattern of conduct sufficient to find that 
there is reason to believe he may violate requirements under the FD&C 
Act relating to drug products.
    As a result of the foregoing finding, Dr. Justice is debarred for 
25 years 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 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), effective (see 
DATES) (see sections 306(c)(1)(B), (c)(2)(A)(ii), and 201(dd) of the 
FD&C Act (21 U.S.C. 335a(c)(1)(B), (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. Justice, in any capacity during Dr. 
Justice's 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 Dr. Justice 
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 applications submitted by or with the assistance of Dr. Justice 
during his period of debarment (section 306(c)(1)(A) of the FD&C Act).
    Any application by Dr. Justice for special termination of debarment 
under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) should 
be identified with Docket No. FDA-2011-N-0860 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: June 22, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-16600 Filed 7-6-12; 8:45 am]
BILLING CODE 4160-01-P