Dilip Patel; Denial of Hearing; Final Debarment Order, 48829-48831 [2018-20977]
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Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
that if you include your name, contact
information, or other information that
identifies you in the body of your
application, that information will be
posted on https://www.regulations.gov.
• If you want to submit an
application with confidential
information that you do not wish to be
made available to the public, submit the
application as a written/paper
submission and in the manner detailed
(see ‘‘Written/Paper Submissions’’ and
‘‘Instructions’’).
[FR Doc. 2018–21033 Filed 9–26–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0329]
Dilip Patel; Denial of Hearing; Final
Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
denying a request for a hearing
submitted by Dilip Patel and is issuing
an order under the Federal Food, Drug,
and Cosmetic Act (FD&C Act) debarring
Patel for 5 years 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 Patel was convicted of a
conspiracy to commit a felony under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act and that the conduct
underlying the conviction undermines
the process for the regulation of drugs.
In determining the appropriateness and
period of Patel’s debarment, FDA
considered the relevant factors listed in
the FD&C Act. Patel failed to file with
the Agency information and analyses
sufficient to create a basis for a hearing
concerning this action.
DATES: The order is applicable
September 27, 2018.
ADDRESSES: Any application for
termination of debarment by Patel under
section 306(d) of the FD&C Act
(application) may be submitted as
follows:
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
Electronic Submissions
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
An application submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
application will be made public, you are
solely responsible for ensuring that your
application 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
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17:20 Sep 26, 2018
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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 a written/paper application
submitted to the Dockets Management
Staff, FDA will post your application, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: Your application must
include the Docket No. FDA–2009–N–
0329. An application will be placed in
the docket and, unless 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.
• Confidential Submissions—To
submit an application with confidential
information that you do not wish to be
made publicly available, submit your
application 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 your application.
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
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 application 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
PO 00000
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48829
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket, 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 between 9 a.m.
and 4 p.m., Monday through Friday.
Publicly available submissions may be
seen in the docket.
FOR FURTHER INFORMATION CONTACT:
Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring,
MD 20993, 240–402–5931.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(II) of the FD&C
Act (21 U.S.C. 335a(b)(2)(B)(i)(II))
permits FDA to debar an individual if it
finds: (1) That the individual has been
convicted of a conspiracy to commit a
felony under Federal law for conduct
relating to the regulation of any drug
product under the FD&C Act and (2)
that the type of conduct which served
as the basis for the conviction
undermines the process for the
regulation of drugs.
On April 24, 2007, Patel pled guilty
to one count of conspiracy to distribute
misbranded and adulterated drugs, in
violation of 18 U.S.C. 371. On December
9, 2010, the U.S. District Court for the
District of New Jersey entered the
conviction, sentenced Patel to 2 years of
probation, and imposed a $3,000 fine.
Patel’s conviction stemmed from his
employment at Able Laboratories, Inc.
(Able), where he was a Supervisor of
Analytical Control and later a Quality
Control Manager in the Quality Control
Department. Patel and his coconspirators conspired and agreed with
others to cause the introduction of
misbranded and adulterated drugs into
interstate commerce with an intent to
defraud and mislead the United States,
in violation of sections 301(a) and
303(a)(2) of the FD&C Act (21 U.S.C.
331(a) and 333(a)(2)). Specifically,
according to the criminal information to
which he pled guilty, Patel supervised
the falsification and manipulation of
assay test results for atenolol, a
prescription medication for cardiac
conditions, and he directed a
subordinate chemist to falsify and
manipulate dissolution test results for
methylphenidate hydrochloride
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Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
extended-release tablets, a prescription
medication for attention deficit and
hyperactivity disorder.
By letter dated January 10, 2012,
FDA’s Office of Regulatory Affairs
(ORA) notified Patel of its proposal to
debar him for 5 years from providing
services in any capacity to a person
having an approved or pending drug
product application. ORA concluded
that Patel should be debarred for 5 years
based on the four applicable
considerations in section 306(c)(3) of
the FD&C Act: (1) The nature and
seriousness of his offense, (2) the nature
and extent of management participation,
(3) the nature and extent of voluntary
steps taken to mitigate the impact on the
public, and (4) prior convictions
involving matters within FDA’s
jurisdiction. ORA found that the nature
and seriousness of the offense, the
nature and extent of management
participation, the nature and extent of
voluntary steps to mitigate the impact
on the public were unfavorable factors
for Patel. ORA found that the absence of
prior convictions involving matters
within FDA’s jurisdiction was a
favorable factor for Patel. ORA
concluded, ‘‘Weighing all the factors,
the Agency has determined that the
unfavorable factors far outweigh the
favorable factor, and therefore warrant
the imposition of a five-year permissible
debarment.’’
In a letter dated January 31, 2012,
through counsel, Patel requested a
hearing. In a letter dated March 1, 2012,
through counsel, Patel submitted a short
summary of arguments to support his
hearing request.
Under the authority delegated to him
by the Commissioner of Food and
Drugs, the Director of the Office of
Scientific Integrity (OSI) has considered
Patel’s submission. Hearings are granted
only if there is a genuine and substantial
issue of fact. Hearings will not be
granted on issues of policy or law, on
mere allegations, denials or general
descriptions of positions and
contentions, or on data and information
insufficient to justify the factual
determination urged (see 21 CFR
12.24(b)).
OSI has considered Patel’s arguments
and concludes that Patel’s arguments
are unpersuasive and fail to raise a
genuine and substantial issue of fact
requiring a hearing.
II. Arguments
In his hearing request, Patel generally
denies: (1) Violating good
manufacturing practice requirements;
(2) violating standard operating
procedures by failing to properly
investigate, log, and archive
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Jkt 244001
questionable, aberrant, and
unacceptable laboratory results, so that
Able could conceal improprieties and
continue to distribute and sell its drug
products; (3) manipulating and
falsifying testing data and information
to conceal from FDA failing laboratory
results relating to Able’s generic drug
products; (4) creating and maintaining
false, fraudulent, and inaccurate test
results to make it appear that drug
products had requisite identity,
strength, quality, and purity
characteristics; and (5) creating and
maintaining false, fraudulent, and
inaccurate data and records to obtain
FDA approval to market new product
lines. Patel also denies that he was in a
managerial position and asserts that he
took voluntary steps to mitigate the
impact of his offenses on the public by
cooperating with law enforcement
officials during the investigation and
subsequent prosecution.
It is unclear whether Patel’s five
enumerated denials are challenges to
ORA’s finding that he is subject to
debarment under section
306(b)(2)(B)(i)(II) of the FD&C Act or its
finding with respect to the
consideration under section
306(c)(3)(A), the nature and seriousness
of his offense. Regardless of how these
denials are directed, they do not create
a genuine and substantial issue of fact
suitable for a hearing. Section 306(l) of
the FD&C Act defines conviction a
Federal or State court’s entry of a
judgment of conviction or acceptance of
a guilty plea. In pleading guilty, Patel
stated that he was voluntarily entering
his guilty plea based on an
understanding of the charges listed in
the information, which included the
factual allegations that he now disputes.
The court then entered a judgment of
conviction after accepting Patel’s guilty
plea. By pleading guilty to the charges
in the information, Patel has already
admitted and been convicted on the
basis of the actions he now denies. Patel
does not dispute that the court entered
a judgment of conviction or that the
court accepted his guilty plea and the
factual admissions underlying it.
Therefore, Patel’s denials, whether
directed at the Agency’s authority to
debar him or the appropriateness or
period of debarment, fail to raise a
genuine and substantial issue of fact
warranting a hearing.
Patel next argues that he was not in
a managerial role at the time of the
offenses and thereby appears to be
challenging ORA’s finding to the
contrary under section 306(c)(3)(B) of
the FD&C Act. In the attachment to
Patel’s plea agreement, Patel stipulated
that he ‘‘was an organizer, leader,
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Sfmt 4703
manager or supervisor of the relevant
criminal activity.’’ Patel is bound by his
stipulation from the criminal
proceedings and cannot now deny his
managerial role. Further, Patel does not
provide any new information that
would overcome his stipulation that he
was in a managerial role; therefore, OSI
concludes that Patel has failed to raise
a genuine and substantial issue of fact
requiring a hearing with respect to
ORA’s finding.
Lastly, Patel claims that he took
voluntary steps to mitigate the impact
on the public by cooperating with law
enforcement officials during the
investigation and subsequent
prosecution of the conduct surrounding
his offense. Patel appears to be
responding to ORA’s finding under
section 306(c)(3)(C) of the FD&C Act
that there is no information
demonstrating such voluntary steps, but
he does not provide any specific
information or arguments to support his
bare assertion that he cooperated with
law enforcement officials. His
unsupported statement that he took
voluntary steps to mitigate the effect of
his offense on the public through
cooperation with law enforcement
officials does not create a genuine and
substantial issue of fact that warrants a
hearing.
Based on the factual findings in the
proposal to debar and on the record, OSI
finds that the proposed 5-year
debarment is appropriate. In particular,
the nature and seriousness of Patel’s
offense weighs significantly in favor of
debarment. As stated in the proposal to
debar, ‘‘[His] conduct created a risk of
injury, undermined the Agency’s
oversight of an approved drug product,
undermined the development or
approval, including the process for
development or approval, of a drug
product, and seriously undermined the
integrity of the Agency’s regulation of
drug products.’’ The nature and extent
of management participation and lack of
voluntary steps to mitigate the impact
on the public also weigh in favor of
debarment. Although Patel does not
appear to have prior criminal
convictions involving matters within
FDA’s jurisdiction, this sole favorable
factor is not enough to outweigh the
factors supporting debarment.
III. Findings and Order
Therefore, the Director of OSI, under
section 306(b)(2)(B)(i)(II) of the FD&C
Act and under authority delegated to
him by the Commissioner of Food and
Drugs, finds that: (1) Patel has been
convicted of a conspiracy to commit a
felony under Federal law for conduct
relating to the regulation of a drug
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Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
product under the FD&C Act and (2)
that the conduct which served as the
basis for the conviction undermines the
process for the regulation of drugs. FDA
has considered the applicable factors
listed in section 306(c)(3) of the FD&C
Act and determined that a debarment of
5 years is appropriate.
As a result of the foregoing findings,
Patel is debarred for 5 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 September
27, 2018 (see 21 U.S.C. 335a(c)(1)(B) and
(c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
Any person with an approved or
pending drug product application, who
knowingly uses the services of Patel, in
any capacity during his period of
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
Patel, 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 FD&C Act). In addition,
FDA will not accept or review any
abbreviated new drug applications
submitted by or with the assistance of
Patel during his period of debarment
(section 306(c)(1)(B) of the FD&C Act).
Dated: September 21, 2018.
George M. Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2018–20977 Filed 9–26–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
[OMB NO. 0917–0028]
Request for Public Comment: 60-Day
Proposed Information Collection:
Addendum to Declaration for Federal
Employment, Child Care and Indian
Child Care Worker Positions
Indian Health Service, HHS.
Notice and request for
comments. Request for extension of
approval.
AGENCY:
daltland on DSKBBV9HB2PROD with NOTICES
ACTION:
In compliance with the
Paperwork Reduction Act of 1995,
which requires 60 days for public
comment on proposed information
collection projects, the Indian Health
Service (IHS) invites the general public
to take this opportunity to comment on
SUMMARY:
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17:20 Sep 26, 2018
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the information collection titled,
‘‘Addendum to Declaration for Federal
Employment, Child Care and Indian
Child Care Worker Positions,’’ Office of
Management and Budget (OMB) Control
Number 0917–0028.
DATES: November 26, 2018. Your
comments regarding this information
collection are best assured of having full
effect if received within 60 days of the
date of this publication.
ADDRESSES: Send your written
comments, requests for more
information on the proposed collection,
or requests to obtain a copy of the data
collection instrument and instructions
to Evonne Bennett-Barnes by one of the
following methods:
• Mail: Evonne Bennett-Barnes,
Information Collection Clearance
Officer, 5600 Fishers Lane, Mail stop:
09E21B, Rockville, MD 20857.
• Email: Evonne.Bennett-Barnes@
ihs.gov.
• Phone: 301–443–4750.
SUPPLEMENTARY INFORMATION: This
previously approved information
collection project was last published in
the Federal Register (80 FR 53812) on
September 8, 2015, and allowed 30 days
for public comment. No public
comment was received in response to
the notice. This notice announces our
intent to submit this collection, which
expires November 30, 2018, to OMB for
approval of an extension, and to solicit
comments on specific aspects for the
proposed information collection.
A copy of the supporting statement is
available at www.regulations.gov (see
Docket ID IHS_FRDOC_0001).
Proposed Collection: Title:
Addendum to Declaration for Federal
Employment, Child Care and Indian
Child Care Worker Positions (OMB No.
0917–0028). Type of Information
Collection Request: Extension, without
revision, of currently approved
information collection, 0917–0028,
Addendum to Declaration for Federal
Employment, Child Care and Indian
Child Care Worker Positions. There are
no program changes or adjustments in
burden hours. Form(s): Addendum to
Declaration for Federal Employment,
Child Care and Indian Child Care
Worker Positions. Need and Use of
Information Collection: This is a request
for approval of the collection of
information as required by section 408
of the Indian Child Protection and
Family Violence Prevention Act, Public
Law (Pub. L.) 101–630, 104 Stat. 4544,
and 25 United States Code (U.S.C.)
§§ 3201–3210.
The IHS is required to compile a list
of all authorized positions within the
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48831
IHS where the duties and
responsibilities involve regular contact
with, or control over, Indian children;
and to conduct an investigation of the
character of each individual who is
employed, or is being considered for
employment, in a position having
regular contact with, or control over,
Indian children. 25 U.S.C. 3207(a)(1)
and (2). Title 25 U.S.C. 3207(a)(3)
requires regulations prescribing the
minimum standards of character for
individuals appointed to positions
involving regular contact with, or
control over, Indian children, and
section 3207(b) provides that such
standards shall ensure that no such
individuals have been found guilty of,
or entered a plea of nolo contendere or
guilty to any felonious offense, or any
two or more misdemeanor offenses,
under Federal, State, or Tribal law
involving crimes of violence; sexual
assault, molestation, exploitation,
contact or prostitution; crimes against
persons; or offenses committed against
children.
In addition, 34 U.S.C. 20351 (formerly
codified at 42 U.S.C. 13041, which was
transferred to 34 U.S.C. 20351) requires
each agency of the Federal Government,
and every facility operated by the
Federal Government (or operated under
contract with the Federal Government),
that hires (or contracts for hire)
individuals involved with the provision
of child care services to children under
the age of 18 to assure that all existing
and newly hired employees undergo a
criminal history background check. The
background investigation is to be
initiated through the personnel program
of the applicable Federal agency. This
section requires employment
applications for individuals who are
seeking work for an agency of the
Federal Government, or for a facility or
program operated by (or through
contract with) the Federal Government,
in positions involved with the provision
of child care services to children under
the age of 18, to contain a question
asking whether the individual has ever
been arrested for or charged with a
crime involving a child, and if so,
requiring a description of the
disposition of the arrest or charge.
Affected Public: Individuals and
households. Type of Respondents:
Individuals.
The table below provides: Types of
data collection instruments, Estimated
number of respondents, Number of
responses per respondent, Average
burden hour per response, and Total
annual burden hour(s).
E:\FR\FM\27SEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Notices]
[Pages 48829-48831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20977]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0329]
Dilip Patel; Denial of Hearing; Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is denying a
request for a hearing submitted by Dilip Patel and is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Patel for 5 years 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 Patel was convicted of a conspiracy to
commit a felony under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act and that the conduct
underlying the conviction undermines the process for the regulation of
drugs. In determining the appropriateness and period of Patel's
debarment, FDA considered the relevant factors listed in the FD&C Act.
Patel failed to file with the Agency information and analyses
sufficient to create a basis for a hearing concerning this action.
DATES: The order is applicable September 27, 2018.
ADDRESSES: Any application for termination of debarment by Patel under
section 306(d) of the FD&C Act (application) may be submitted as
follows:
Electronic Submissions
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application 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 application,
that information will be posted on https://www.regulations.gov.
If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application 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 a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: Your application must include the Docket No. FDA-
2009-N-0329. An application will be placed in the docket and, unless
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.
Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application 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 your application. 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 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 application 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket, 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 between 9 a.m. and 4 p.m., Monday through Friday. Publicly
available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(II) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(II)) permits FDA to debar an individual if it finds:
(1) That the individual has been convicted of a conspiracy to commit a
felony under Federal law for conduct relating to the regulation of any
drug product under the FD&C Act and (2) that the type of conduct which
served as the basis for the conviction undermines the process for the
regulation of drugs.
On April 24, 2007, Patel pled guilty to one count of conspiracy to
distribute misbranded and adulterated drugs, in violation of 18 U.S.C.
371. On December 9, 2010, the U.S. District Court for the District of
New Jersey entered the conviction, sentenced Patel to 2 years of
probation, and imposed a $3,000 fine. Patel's conviction stemmed from
his employment at Able Laboratories, Inc. (Able), where he was a
Supervisor of Analytical Control and later a Quality Control Manager in
the Quality Control Department. Patel and his co-conspirators conspired
and agreed with others to cause the introduction of misbranded and
adulterated drugs into interstate commerce with an intent to defraud
and mislead the United States, in violation of sections 301(a) and
303(a)(2) of the FD&C Act (21 U.S.C. 331(a) and 333(a)(2)).
Specifically, according to the criminal information to which he pled
guilty, Patel supervised the falsification and manipulation of assay
test results for atenolol, a prescription medication for cardiac
conditions, and he directed a subordinate chemist to falsify and
manipulate dissolution test results for methylphenidate hydrochloride
[[Page 48830]]
extended-release tablets, a prescription medication for attention
deficit and hyperactivity disorder.
By letter dated January 10, 2012, FDA's Office of Regulatory
Affairs (ORA) notified Patel of its proposal to debar him for 5 years
from providing services in any capacity to a person having an approved
or pending drug product application. ORA concluded that Patel should be
debarred for 5 years based on the four applicable considerations in
section 306(c)(3) of the FD&C Act: (1) The nature and seriousness of
his offense, (2) the nature and extent of management participation, (3)
the nature and extent of voluntary steps taken to mitigate the impact
on the public, and (4) prior convictions involving matters within FDA's
jurisdiction. ORA found that the nature and seriousness of the offense,
the nature and extent of management participation, the nature and
extent of voluntary steps to mitigate the impact on the public were
unfavorable factors for Patel. ORA found that the absence of prior
convictions involving matters within FDA's jurisdiction was a favorable
factor for Patel. ORA concluded, ``Weighing all the factors, the Agency
has determined that the unfavorable factors far outweigh the favorable
factor, and therefore warrant the imposition of a five-year permissible
debarment.''
In a letter dated January 31, 2012, through counsel, Patel
requested a hearing. In a letter dated March 1, 2012, through counsel,
Patel submitted a short summary of arguments to support his hearing
request.
Under the authority delegated to him by the Commissioner of Food
and Drugs, the Director of the Office of Scientific Integrity (OSI) has
considered Patel's submission. Hearings are granted only if there is a
genuine and substantial issue of fact. Hearings will not be granted on
issues of policy or law, on mere allegations, denials or general
descriptions of positions and contentions, or on data and information
insufficient to justify the factual determination urged (see 21 CFR
12.24(b)).
OSI has considered Patel's arguments and concludes that Patel's
arguments are unpersuasive and fail to raise a genuine and substantial
issue of fact requiring a hearing.
II. Arguments
In his hearing request, Patel generally denies: (1) Violating good
manufacturing practice requirements; (2) violating standard operating
procedures by failing to properly investigate, log, and archive
questionable, aberrant, and unacceptable laboratory results, so that
Able could conceal improprieties and continue to distribute and sell
its drug products; (3) manipulating and falsifying testing data and
information to conceal from FDA failing laboratory results relating to
Able's generic drug products; (4) creating and maintaining false,
fraudulent, and inaccurate test results to make it appear that drug
products had requisite identity, strength, quality, and purity
characteristics; and (5) creating and maintaining false, fraudulent,
and inaccurate data and records to obtain FDA approval to market new
product lines. Patel also denies that he was in a managerial position
and asserts that he took voluntary steps to mitigate the impact of his
offenses on the public by cooperating with law enforcement officials
during the investigation and subsequent prosecution.
It is unclear whether Patel's five enumerated denials are
challenges to ORA's finding that he is subject to debarment under
section 306(b)(2)(B)(i)(II) of the FD&C Act or its finding with respect
to the consideration under section 306(c)(3)(A), the nature and
seriousness of his offense. Regardless of how these denials are
directed, they do not create a genuine and substantial issue of fact
suitable for a hearing. Section 306(l) of the FD&C Act defines
conviction a Federal or State court's entry of a judgment of conviction
or acceptance of a guilty plea. In pleading guilty, Patel stated that
he was voluntarily entering his guilty plea based on an understanding
of the charges listed in the information, which included the factual
allegations that he now disputes. The court then entered a judgment of
conviction after accepting Patel's guilty plea. By pleading guilty to
the charges in the information, Patel has already admitted and been
convicted on the basis of the actions he now denies. Patel does not
dispute that the court entered a judgment of conviction or that the
court accepted his guilty plea and the factual admissions underlying
it. Therefore, Patel's denials, whether directed at the Agency's
authority to debar him or the appropriateness or period of debarment,
fail to raise a genuine and substantial issue of fact warranting a
hearing.
Patel next argues that he was not in a managerial role at the time
of the offenses and thereby appears to be challenging ORA's finding to
the contrary under section 306(c)(3)(B) of the FD&C Act. In the
attachment to Patel's plea agreement, Patel stipulated that he ``was an
organizer, leader, manager or supervisor of the relevant criminal
activity.'' Patel is bound by his stipulation from the criminal
proceedings and cannot now deny his managerial role. Further, Patel
does not provide any new information that would overcome his
stipulation that he was in a managerial role; therefore, OSI concludes
that Patel has failed to raise a genuine and substantial issue of fact
requiring a hearing with respect to ORA's finding.
Lastly, Patel claims that he took voluntary steps to mitigate the
impact on the public by cooperating with law enforcement officials
during the investigation and subsequent prosecution of the conduct
surrounding his offense. Patel appears to be responding to ORA's
finding under section 306(c)(3)(C) of the FD&C Act that there is no
information demonstrating such voluntary steps, but he does not provide
any specific information or arguments to support his bare assertion
that he cooperated with law enforcement officials. His unsupported
statement that he took voluntary steps to mitigate the effect of his
offense on the public through cooperation with law enforcement
officials does not create a genuine and substantial issue of fact that
warrants a hearing.
Based on the factual findings in the proposal to debar and on the
record, OSI finds that the proposed 5-year debarment is appropriate. In
particular, the nature and seriousness of Patel's offense weighs
significantly in favor of debarment. As stated in the proposal to
debar, ``[His] conduct created a risk of injury, undermined the
Agency's oversight of an approved drug product, undermined the
development or approval, including the process for development or
approval, of a drug product, and seriously undermined the integrity of
the Agency's regulation of drug products.'' The nature and extent of
management participation and lack of voluntary steps to mitigate the
impact on the public also weigh in favor of debarment. Although Patel
does not appear to have prior criminal convictions involving matters
within FDA's jurisdiction, this sole favorable factor is not enough to
outweigh the factors supporting debarment.
III. Findings and Order
Therefore, the Director of OSI, under section 306(b)(2)(B)(i)(II)
of the FD&C Act and under authority delegated to him by the
Commissioner of Food and Drugs, finds that: (1) Patel has been
convicted of a conspiracy to commit a felony under Federal law for
conduct relating to the regulation of a drug
[[Page 48831]]
product under the FD&C Act and (2) that the conduct which served as the
basis for the conviction undermines the process for the regulation of
drugs. FDA has considered the applicable factors listed in section
306(c)(3) of the FD&C Act and determined that a debarment of 5 years is
appropriate.
As a result of the foregoing findings, Patel is debarred for 5
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
September 27, 2018 (see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and
21 U.S.C. 321(dd)). Any person with an approved or pending drug product
application, who knowingly uses the services of Patel, in any capacity
during his period of 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 Patel, 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 FD&C Act). In addition, FDA will not accept or review
any abbreviated new drug applications submitted by or with the
assistance of Patel during his period of debarment (section
306(c)(1)(B) of the FD&C Act).
Dated: September 21, 2018.
George M. Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2018-20977 Filed 9-26-18; 8:45 am]
BILLING CODE 4164-01-P
