[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]
 BILLING CODE 4164-01-P


