[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41486-41488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0198]


Belen G. Ngo; 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) is denying Belen G. 
Ngo's (Ms. Ngo's) request for a hearing and is issuing an order under 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Ms. Ngo 
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 Ms. Ngo was convicted of a misdemeanor under 
Federal law for conduct relating to the development or approval of a 
drug product or otherwise relating to the regulation of a drug product 
under the FD&C Act and that the type of conduct underlying the 
conviction undermines the process for the regulation of drugs. In 
determining the appropriateness and period of Ms. Ngo's debarment, FDA 
considered the relevant factors listed in the FD&C Act. Ms. Ngo failed 
to file with the Agency information and analyses sufficient to create a 
basis for a hearing concerning this action.

DATES: This order is applicable August 2, 2021.

ADDRESSES: Any application for termination of debarment by Ms. Ngo 
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: All applications must include the Docket No. FDA-
2012-N-0198. Received applications will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at

[[Page 41487]]

https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-
7500. 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)(I) of the FD&C Act (21 U.S.C. 
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds 
that: (1) The individual was convicted of a misdemeanor under Federal 
law for conduct relating to the development or approval of a drug 
product or otherwise relating to the regulation of a drug product under 
the FD&C Act and (2) that the type of conduct underlying the conviction 
undermines the process for the regulation of drugs.
    On September 6, 2011, in the U.S. District Court for the Eastern 
District of Virginia, Ms. Ngo pled guilty to a misdemeanor violation of 
the FD&C Act, namely failing to maintain records required by section 
505(i) of the FD&C Act (21 U.S.C. 355(i)) in violation of sections 
301(e) and 303(a)(1) (21 U.S.C. 331(e) and 333(a)(1)). Ms. Ngo's 
conviction stemmed from her actions as a clinical research coordinator 
for the Norfolk Diagnostic Center, doing business as Sentara Medical 
Group (Sentara). Eli Lilly Corp. (Eli Lilly) initiated a clinical study 
to investigate the effectiveness of lispro insulin for the purpose of 
applying for FDA approval to market lispro insulin for the treatment of 
Type 2 diabetes. Eli Lilly entered into an agreement with Sentara to 
conduct the ispro insulin study, and Sentara agreed to maintain records 
in accordance with 21 CFR 312.62(a) and by extension, section 505(i) of 
the FD&C Act. Ms. Ngo was a clinical research coordinator for the 
lispro insulin study and responsible for maintaining and completing 
case report forms (CRFs), which are the official records that document 
volunteers' participation in the study and contain vital medical 
information related to the performance of the study drug. Ms. Ngo 
knowingly and repeatedly falsified CRFs.
    By letter dated April 27, 2012, FDA's Office of Regulatory Affairs 
(ORA) notified Ms. Ngo of its proposal to debar her for 5 years from 
providing services in any capacity to a person having an approved or 
pending drug product application. The proposal explained that the 
proposed debarment period was based on her misdemeanor conviction and 
that the maximum debarment period is 5 years. ORA explained that her 
conduct relating to the clinical trial relates to the development and 
approval, including the process for development and approval, of drug 
products; therefore, she was subject to debarment under section 
306(b)(2)(B)(i)(I) of the FD&C Act.
    The proposal outlined findings regarding the three applicable 
factors ORA considered in determining the appropriateness and period of 
debarment, as provided in section 306(c)(3) of the FD&C Act. ORA 
consider the nature and seriousness of the offense and the nature and 
extent of voluntary steps to mitigate the effect on the public as 
unfavorable factors for Ms. Ngo and weighed these factors against the 
absence of prior convictions involving matters within FDA's 
jurisdiction. 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 period of 
debarment in this case, the maximum possible period of debarment.''
    By letters dated May 22 and 23, 2012, through counsel, Ms. Ngo 
requested a hearing on the proposal. In her request for a hearing, Ms. 
Ngo acknowledges her conviction under Federal law and does not question 
the Agency's authority to debar her upon the basis of that conviction. 
However, Ms. Ngo argues that she should only be subject to a 1-year 
debarment, rather than FDA's proposed 5-year debarment, based on the 
considerations for determining the appropriateness and period of 
debarment under section 306(c)(3) of the FD&C Act. Ms. Ngo also 
included specific arguments related to the considerations under section 
306(c)(3) of the FD&C Act.
    Under the authority delegated by the Commissioner of Food and 
Drugs, the Chief Scientist has considered Ms. Ngo's request for a 
hearing. 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)).
    The Chief Scientist has considered Ms. Ngo's arguments and 
concluded that they are unpersuasive and fail to raise a genuine and 
substantial issue of fact requiring a hearing.

II. Arguments

    In support of her hearing request, Ms. Ngo makes many statements 
seemingly related to the nature and seriousness of her offense. Ms. Ngo 
first argues that the prosecution's failure to pursue a felony 
conviction reflects its judgment that a misdemeanor conviction and the 
terms of her probation or supervised release, which included an 
agreement not to engage in clinical research during that period, are 
sufficient to protect the public health. Ms. Ngo next argues that her 
role was too small to have a significant effect on the study's results 
and that, because of her ``minimal role'' in providing data, the 
maximum debarment period is not appropriate. Ms. Ngo states that her 
study was discontinued and Eli Lilly did not use any of her information 
``in a detrimental way.'' Ms. Ngo also alleges that ``[t]here is no 
evidence that her data affected the

[[Page 41488]]

studies or resulted in the production of the drugs affected by the 
fraud'' and that ``[t]he drugs produced were free of fraud and material 
false statements.'' Ms. Ngo then asserts that her lack of financial 
motive for conducting her offense weighs in her favor because ``the 
maximum period of debarment should be reserved for those who profit.''
    In determining the period of Ms. Ngo's debarment, whether she could 
have been convicted of a felony is not relevant. Under section 
306(c)(3) of the FD&C act, FDA considers the nature and seriousness of 
the offense. Ms. Ngo admitted to knowingly and repeatedly falsifying 
clinical trial records. Additionally, the inclusion of a provision in 
Ms. Ngo's plea agreement that prevents her from engaging in clinical 
research ``during any term of probation or supervised release'' evinces 
concern by the prosecution that she would continue to violate the law 
if involved in clinical research.
    As set forth in the proposal to debar, ``[t]he creation and 
submission of falsified clinical trial data undermines FDA's 
determination of safety, effectiveness, and quality of the drugs the 
studies were designed to assess.'' Although the scope of conduct to 
which Ms. Ngo admitted during the criminal proceedings may have been 
limited to a few patients, submitting any false or fabricated data to 
the FDA is a serious offense that compromises the public health. 
Further, it is irrelevant that Eli Lilly ultimately did not use any of 
her information ``in a detrimental way.'' Had Ms. Ngo's conduct gone 
undetected and Eli Lilly submitted a new drug application containing 
the falsified data, FDA might have relied on her fabricated information 
to approve a new drug product, which reliance could have compromised 
the public health. Additionally, Ms. Ngo's lack of financial gain from 
her conduct does not diminish the nature and seriousness of her 
offense. Accordingly, Ms. Ngo has failed to create a genuine and 
material factual dispute with respect to the nature and seriousness of 
her offense.
    Ms. Ngo next argues that, because she has not been involved in 
clinical trials since entering her guilty plea, there are ``reasonable 
assurances'' that ``the offense will not happen again.'' Ms. Ngo 
appears to be referencing the consideration under section 306(c)(3)(D) 
of the FD&C Act, where FDA must consider, where applicable, ``whether 
the extent to which changes in ownership, management, or operations 
have corrected the causes of any offense involved and provide 
reasonable assurances that the offense will not occur in the future.'' 
The considerations in section 306(c)(3) of the FD&C Act are not only 
for individuals but also for corporations, partnerships, and 
associations subject to permissive debarment. The consideration at 
issue does not typically apply to individuals because individuals are 
incapable of changes in ownership or management and could only alter 
the current operations of a business enterprise in which they are 
currently engaged. Even assuming for the sake of argument that an 
individual could point to changes in his or her current business 
practices as an applicable consideration under section 306(c)(3) of the 
FD&C Act, Ms. Ngo offers no actual facts to support her assertion that 
there are reasonable assurances that the offense will not occur again 
in the future; therefore, her unsubstantiated contention that, because 
she has not been involved in clinical trials since entering her guilty 
plea provides reasonable assurances that she will not commit the 
offense again, fails to create a genuine and substantial issue of fact 
that warrants a hearing.
    Finally, Ms. Ngo argues that the maximum period of debarment is 
inappropriate for first-time offenders. While the Agency does consider 
prior convictions involving matters within the FDA's jurisdiction under 
section 306(c)(3)(F) of the FD&C Act, that consideration is only one of 
several that FDA considers in determining the appropriateness and 
period of debarment under section 306(c)(3). Ms. Ngo knowingly and 
repeatedly falsified clinical data records. FDA has determined that the 
conduct underlying her offense, combined with her failure to take any 
voluntary steps to mitigate the effect of her offense on the public, is 
sufficiently serious to warrant a 5-year period of debarment, even 
though she does not have any prior convictions involving matters within 
the Agency's jurisdiction.

III. Findings and Order

    Therefore, the Chief Scientist, under section 306(b)(2)(B)(i)(I) of 
the FD&C Act and under the authority delegated to her by the 
Commissioner of Food and Drugs, finds: (1) That Ms. Ngo has been 
convicted of a misdemeanor under Federal law for conduct relating to 
the development or approval of a drug product or otherwise relating to 
the regulation of a drug product under the FD&C Act and (2) that the 
conduct underlying the conviction undermines the process for the 
regulation of drugs. FDA has considered the relevant 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, Ms. Ngo is debarred for 5 
years from providing services in any capacity to a person with an 
approved or pending drug product application under section 505, 512, or 
802 of the FD&C Act (21 U.S.C. 335, 360b, or 382), or under section 351 
of the Public Health Service Act (42 U.S.C. 262), effective August 2, 
2021 (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 Ms. Ngo, in any 
capacity during her 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 Ms. Ngo, during her period of debarment, provides services in any 
capacity to a person with an approved or pending drug product 
application, that person 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 Ms. Ngo during her period of debarment (section 
306(c)(1)(B) of the FD&C Act).

    Dated: July 27, 2021.
Denise Hinton,
Chief Scientist.
[FR Doc. 2021-16352 Filed 7-30-21; 8:45 am]
BILLING CODE 4164-01-P