[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)]
[Notices]
[Pages 49211-49214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23019]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0278]


Trand Doan Nguyen; 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 Trang Doan 
Nguyen's (Nguyen's) request for a hearing and is issuing an order under 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring 
Nguyen 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 Nguyen was convicted of a misdemeanor 
under Federal law for conduct relating to the development or approval 
of a drug product or otherwise relating 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 Nguyen's debarment, FDA 
has considered the relevant factors listed in the FD&C Act. Nguyen has 
failed to file with the Agency information and analyses sufficient to 
create a basis for a hearing concerning this action.

DATES: The order is effective October 24, 2017.

ADDRESSES: Any application by Nguyen for special termination of 
debarment 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-
2011-N-0278. 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

[[Page 49212]]

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.

FOR FURTHER INFORMATION CONTACT: Nathan R. Sabel, Office of Scientific 
Integrity, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 1, Rm. 4218, Silver Spring, MD 20993, 301-796-8588.

SUPPLEMENTARY INFORMATION: 

I. Background

    On December 12, 2008, in the U.S. District Court for the District 
of Missouri, Nguyen pled guilty to a misdemeanor for introducing a 
misbranded drug into interstate commerce in violation of sections 
301(a) and 303(a)(1) of the FD&C Act (21 U.S.C. 331(a) and 333(a)(1)). 
The basis for Nguyen's guilty plea was her admission that she 
repackaged unapproved versions of the drugs LIPITOR and CELEBREX, some 
of which were counterfeit, and relabeled them in a manner that did not 
disclose that they were unapproved or that they were counterfeit and 
then shipped them to other States. The drugs were misbranded under 
section 502(a) of the FD&C Act (21 U.S.C. 352(a)) in that their 
labeling was false and misleading.
    Nguyen is subject to debarment based on a finding, under section 
306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)): (1) 
That she 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. By letter dated July 6, 2011, FDA 
served Nguyen a notice proposing to debar her for 5 years from 
providing services in any capacity to a person having an approved or 
pending drug product application and providing an opportunity for 
Nguyen to request a hearing. In a letter dated July 29, 2011, Nguyen 
requested a hearing on the proposal. In her request for a hearing, 
Nguyen acknowledges her conviction under Federal law, as stated by FDA 
in the proposal to debar. However, she argues that the proposal to 
debar her contains material inaccuracies with respect to certain facts 
related to her misdemeanor conviction.
    The Directors of the Office of Scientific Integrity (OSI) reviewed 
Nguyen's request for a hearing, as well as the materials offered in 
support, and find that Nguyen has not created a basis for a hearing 
because hearings will be granted only if there is a genuine and 
substantial issue of fact for resolution at a hearing. 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 Director of OSI has considered Nguyen's arguments and concludes 
that they are unpersuasive and fail to raise a genuine and substantial 
issue of fact requiring a hearing.

II. Arguments

    Nguyen raises a number of arguments in support of her hearing 
request. She does not appear, however, to dispute that she is subject 
to debarment under section 306(b)(2)(B)(i)(I) of the FD&C Act. As noted 
above, to debar Nguyen under section 306(b)(2)(B)(i)(I), FDA must find 
both: (1) That Nguyen was convicted of a misdemeanor under Federal law 
for conduct relating to the development or approval of a drug product 
or otherwise relating 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. As set forth in the 
proposal to debar Nguyen, her Federal misdemeanor conviction involved a 
violation of the FD&C Act's requirements for drugs. As a result, the 
conduct underlying her conviction both related to the regulation of 
drug products under the FD&C Act and undermined the process for the 
regulation of drugs. Nguyen does not contradict the findings to that 
effect in the proposal to debar and has thus failed to create a 
material factual dispute with respect to whether she is subject to 
debarment under section 306(b)(2)(B)(i)(I) of the FD&C Act.
    In her request for a hearing, Nguyen argues nonetheless that she is 
entitled to a hearing because, in the proposal to debar, FDA relied on 
findings that are not supported by the record in determining the 
appropriateness and period of debarment under section 306(c)(3) of the 
FD&C Act. Under section 306(i) of the FD&C Act, FDA may not take any 
action under sections 306(b) or section 306(c) with respect to any 
person ``unless [FDA] has issued an order for such action made on the 
record after opportunity for agency hearing on disputed issues of 
material fact.'' Section 306(c)(3) explicitly requires FDA to consider, 
``where applicable,'' certain factors ``[i]n determining the 
appropriateness and the period of debarment'' for any permissive 
debarment. The proposal to debar Nguyen set forth four applicable 
considerations under section 306(c)(3): (1) The nature and seriousness 
of her offense under section 306(c)(3)(A); (2) the nature and extent of 
management participation in the offense under section 306(c)(3)(B); (3) 
the nature and extent of voluntary steps taken to mitigate the impact 
on the public under section 306(c)(3)(C); and (4) prior convictions 
involving matters within the jurisdiction of FDA under section 
306(c)(3)(F) of the FD&C Act. In the proposal, FDA found that the first 
three considerations weigh in favor of debarring Nguyen and noted that 
the fourth consideration would be treated as a favorable factor for her 
because the Agency was unaware of any prior convictions involving 
matters within the jurisdiction of FDA.
    Nguyen's challenge to specific findings in the proposal to debar 
fails to create a genuine and substantial dispute of fact for 
resolution at a hearing with respect to any of the applicable 
considerations under section 306(c)(3) of the FD&C Act. In her request 
for a hearing, Nguyen argues that the records of her criminal 
proceedings do not support certain findings in the proposal to debar. 
Specifically, she contends that neither the plea agreement nor the 
criminal information to which she pled guilty support the following 
findings: (1) That she was ``aware that the drugs [in question] needed 
to be relabeled for sale in the United States,'' (2) that some of the 
drugs bore labeling in Portuguese before they were relabeled, or (3) 
that the conduct underlying her conviction continued for 13 months. 
Even after disregarding the findings in the proposal to debar to which 
Nguyen objects, we find that she should be debarred for the maximum 
period of 5 years.
    Nguyen's factual objections relate primarily to the consideration 
of the nature and seriousness of her offense under section 306(c)(3)(A) 
of the FD&C

[[Page 49213]]

Act. As noted previously, Nguyen pled guilty to a misdemeanor under the 
FD&C Act by admitting that she acquired, repackaged, relabeled, and 
distributed unapproved prescription drugs in interstate commerce. In 
her criminal proceedings, Nguyen also admitted that some of these 
unapproved prescription drugs were counterfeit drugs. By definition, a 
counterfeit drug is a drug whose container or labeling falsely 
describes the manufacturer, processer, packer, or distributer of that 
drug (see 21 U.S.C. 331(g)(2)) and thereby can effectively conceal the 
actual manufacturer, processer, packer, or distributer from consumers 
and government regulators. An unapproved drug in this context is a drug 
requiring but lacking FDA approval that is not generally recognized as 
safe and effective for its intended use (see 21 U.S.C. 331(g)(1)). As 
such, the products that Nguyen admitted to acquiring, repackaging, 
relabeling, and further distributing were not simply misbranded in some 
technical sense.
    With respect to Nguyen's assertion that her offense was committed 
without knowledge, section 306(b)(2)(B)(i) of the FD&C Act specifically 
provides for the debarment of individuals convicted of Federal 
misdemeanors related to the regulation of drug products under the FD&C 
Act. Given that a misdemeanor violation of the FD&C Act itself is a 
strict liability offense, meaning an offense that does not require 
proof of knowledge as an element of the crime, it stands to reason that 
criminal intent is not required to subject an individual to debarment 
under section 306(b)(2)(B)(i). As recognized by the U.S. Supreme Court, 
an individual who is responsible for the operation of an FDA-regulated 
business is also responsible for any violations of the FD&C Act that 
arise out of the conduct of the business, whether or not he or she 
intends to commit the violations or even knows that the violations have 
been committed. (United States v. Park, 421 U.S. 658 (1975); United 
States v. Dotterweich, 320 U.S. 277 (1943)). In keeping with the FD&C 
Act's purpose of protecting the public from adulterated and misbranded 
products, Congress chose to place the burden of protecting the public 
on those who manufacture and distribute those products rather than on 
consumers, who cannot protect themselves. (Dotterweich, 320 U.S. at 
280-81.) Nguyen herself chose to run a business that acquired, 
repackaged, relabeled, and further distributed prescription drugs to 
consumers who were unable to protect themselves from the unapproved and 
counterfeit products that Nguyen admitted to providing them.
    Even though the law subjects Nguyen to permissive debarment as a 
responsible corporate officer regardless of her knowledge or intent to 
commit the violation, Nguyen has admitted that she personally engaged 
in the conduct underlying the violation as a hands-on participant. 
Nguyen admitted in her plea that she repackaged the drugs and affixed 
labeling to these prescription drugs that did not disclose that the 
drugs were counterfeit and not approved by FDA. Nguyen admitted that 
she repackaged and affixed this false and misleading labeling to these 
prescription drugs and then shipped these drugs in interstate commerce 
for eventual use by the unknowing public. In light of these undisputed 
and admitted facts, even crediting Nguyen's objections related to her 
level of knowledge, the precise language of the product labeling on 
some of the drugs she received, and the precise length of time she 
committed this offense, these objections do not minimize the nature and 
seriousness the conduct Nguyen both committed and admitted. The 
proposal to debar alleges that Nguyen's conduct ``created a significant 
risk of injury to consumers who were exposed to misbranded drugs and 
seriously undermined the integrity of the Agency's regulation of drug 
products.'' Because of the uncontested and admitted facts already 
discussed, Nguyen's objections, even if taken as true, would not 
undermine this conclusion. Therefore, we conclude that the nature and 
seriousness of her conduct weighs in favor of debarring Nguyen.
    Having found that the consideration in section 306(c)(3)(A) of the 
FD&C Act weighs in favor of debarring Nguyen, we turn to the remaining 
three applicable considerations. Nguyen does not dispute the 
unfavorable facts in the FDA proposal to debar that relate to the 
considerations in sections 306(c)(3)(B) and (C) of the FD&C Act. 
Specifically, Nguyen does not dispute the findings in the proposal that 
she used a company of which she was the owner and operator, AQ 
Pharmaceuticals, Inc., to distribute the unapproved and counterfeit 
drugs and that she served in a managerial role in this offense. Nor 
does Nguyen contradict the findings in the proposal to debar that she 
and her company did not discontinue their illegal conduct until it was 
discovered by authorities. In her hearing request, Nguyen does not 
point to any voluntary steps taken to mitigate the effect of her 
offenses on the public. Thus, the considerations in sections 
306(c)(3)(B) and (C) of the FD&C Act regarding Nguyen's management role 
and the voluntary steps taken by Nguyen to mitigate the impact of her 
offense on the public both weigh in favor of her debarment. Although 
Nguyen appears to have no previous criminal convictions related to 
matters within the jurisdiction of FDA (see section 306(c)(3)(F) of the 
FD&C Act), this consideration alone does not counter to a sufficient 
degree the nature and seriousness of the conduct underlying her 
misdemeanor conviction, her managerial role in the offense, and the 
lack of any voluntary steps taken to mitigate the impact of that 
offense of the public, to warrant decreasing the period of debarment 
from 5 years.

III. Findings and Order

    Therefore, the Director of OSI, under section 306(b)(1)(B)(i)(I) of 
the FD&C Act and under authority delegated to him by the Commissioner 
of Food and Drugs, finds that Nguyen has been convicted of a 
misdemeanor under Federal law for conduct relating to the development 
or approval of a drug product or otherwise relating the regulation of a 
drug product under the FD&C Act and that the conduct underlying the 
conviction undermines 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, Nguyen 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. 355, 360b, or 382), or under section 351 
of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) 
(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 Nguyen, in any capacity during her 
period of debarment, will be subject to civil money penalties. If 
Nguyen, during her period of debarment, provides services in any 
capacity to a person with an approved or pending drug product 
application, she will be subject to civil money penalties. In addition, 
FDA will not accept or review any abbreviated new drug applications 
submitted by or with the assistance of Nguyen during her period of 
debarment.


[[Page 49214]]


    Dated: October 19, 2017.
G. Matthew Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2017-23019 Filed 10-23-17; 8:45 am]
 BILLING CODE 4164-01-P


