[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