[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]
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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.
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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]
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