Notice2021-16352
Belen G. Ngo; Denial of Hearing; Final Debarment Order
Primary source
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Published
August 2, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 145 (Monday, August 2, 2021)</title>
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[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41486-41488]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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]]
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.