81 FR 14862 - Wesley A. McQuerry: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 53 (March 18, 2016)

Page Range		14862-14863
FR Document		2016-06104

The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Wesley A. McQuerry 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 Mr. McQuerry was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product and otherwise relating to the regulation of a drug product under the FD&C Act. Mr. McQuerry was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. McQuerry failed to respond. Mr. McQuerry's failure to respond constitutes a waiver of his right to a hearing concerning this action.

Federal Register, Volume 81 Issue 53 (Friday, March 18, 2016)

[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14862-14863]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3225]


Wesley A. McQuerry: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The U.S. Food and Drug Administration (FDA or Agency) is 
issuing an order under the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) permanently debarring Wesley A. McQuerry 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 Mr. 
McQuerry was convicted of a felony under Federal law for conduct 
relating to the development or approval, including the process for 
development or approval, of a drug product and otherwise relating to 
the regulation of a drug product under the FD&C Act. Mr. McQuerry was 
given notice of the proposed permanent debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Mr. 
McQuerry failed to respond. Mr. McQuerry's failure to respond 
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is effective March 18, 2016.

ADDRESSES: Submit applications for special termination of debarment to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, (ELEM-4144), Division of 
Enforcement, Office of Enforcement and Import Operations, Office of 
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., 
Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A)) 
requires debarment of an individual if FDA finds that the individual 
has been convicted of a felony under Federal law for conduct relating 
to the development or approval, including the process for development 
or approval, of any drug product. Section 306(a)(2)(B) of the FD&C Act 
requires debarment of an individual if FDA finds that the individual 
has been convicted of a felony under Federal law for conduct otherwise 
relating to the regulation of any drug product under the FD&C Act. On 
February 10, 2015, the U.S. District Court for the Northern District of 
Illinois entered judgment against Mr. McQuerry for one count of 
falsifying a material fact, in violation of 18 U.S.C. 1001(a)(1).
    The factual basis for this conviction is as follows: Mr. McQuerry 
was the study coordinator for a drug clinical trial at an institution 
in the Northern District of Illinois. The clinical trial occurred under 
the authority of FDA, and clinical trial data was required to be 
submitted to FDA before the drug could be approved for sale in the 
United States.
    As study coordinator, Mr. McQuerry's responsibilities for 
administering the clinical trial included, among other things, 
coordinating patient visits, maintaining patient files, ensuring that 
administrative procedures were followed regarding the collection of 
patient data, disbursing American Express gift checks to trial 
participants, and transmitting clinical trial data from the institution 
to the administrator, which was administering the clinical trial on 
behalf of the pharmaceutical company. Mr. McQuerry knew that the 
results of the clinical trial would be reported to FDA, and he knew it 
was unlawful to provide false information to the pharmaceutical 
company.
    Beginning no later than January 2008, and continuing through at 
least October 2008, in the Northern District of Illinois, Mr. McQuerry 
knowingly and willfully falsified, concealed, and covered up by trick, 
scheme, and device material facts in a matter within the jurisdiction 
of FDA, namely that at least four patients and others were 
participating in the drug clinical trial, when in fact these patients 
did not participate in that clinical trial. Specifically, between 
January and October 2008, Mr. McQuerry created fifteen to twenty 
fictional patients, whom he claimed were participants in the clinical 
trial. Mr. McQuerry falsified signatures of those patients on consent 
forms and falsified doctors' signatures on medical evaluations for 
those patients. He provided his own blood, stool, and EKG results, 
which he claimed were provided by the fictional patients. He also 
transmitted false data and information to the administrator regarding 
these fictional patients and made and caused to be made false 
statements regarding their participation in the study and attendance at 
office visits, all of which he knew would be provided to the 
pharmaceutical company and to FDA.
    Mr. McQuerry made false statements to the administrator about the 
whereabouts of the fictitious trial participants. In particular, on 
August 28, 2008, he provided false and fraudulent statements to the 
administrator regarding the attendance of two patients at study visits, 
knowing that the two patients were not in fact enrolled in the study 
and did not attend a single study visit.
    As study coordinator, Mr. McQuerry was responsible for disbursing 
gift checks, which were provided by the pharmaceutical company to 
patients at various points during the patients' participation in the 
clinical trial. Mr. McQuerry falsely and fraudulently claimed to have 
disbursed gift checks when, in fact, no checks were disbursed

[[Page 14863]]

to patients. Instead, between approximately July 11, 2008 and September 
3, 2008, Mr. McQuerry deposited over $2,300 of gift checks into his 
personal bank account. He additionally used the gift checks to make 
direct purchases at various retailers. Mr. McQuerry's fraud resulted in 
a loss of approximately $200,098 to the pharmaceutical company.
    As a result of this conviction, FDA sent Mr. McQuerry by certified 
mail on October 30, 2015, a notice proposing to permanently debar him 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
a finding, under section 306(a)(2)(A) and (a)(2)(B) of the FD&C Act, 
that Mr. McQuerry was convicted of a felony under Federal law for 
conduct relating to the development or approval, including the process 
for development or approval, of a drug product, and conduct otherwise 
relating to the regulation of a drug product under the FD&C Act. The 
proposal also offered Mr. McQuerry an opportunity to request a hearing, 
providing him 30 days from the date of receipt of the letter in which 
to file the request, and advised him that failure to request a hearing 
constituted a waiver of the opportunity for a hearing and of any 
contentions concerning this action. Mr. McQuerry did not request a 
hearing and has, therefore, waived his opportunity for a hearing and 
any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import 
Operations, Office of Regulatory Affairs, under sections 306(a)(2)(A) 
and (a)(2)(B) of the FD&C Act, under authority delegated to him (Staff 
Manual Guide 1410.35), finds that Wesley A. McQuerry has been convicted 
of a felony under Federal law for conduct relating to the development 
or approval, including the process for development or approval, of a 
drug product and conduct otherwise relating to the regulation of a drug 
product under the FD&C Act.
    As a result of the foregoing finding, Wesley A. McQuerry is 
permanently debarred 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 (see DATES) (see section 201(dd), 306(c)(1)(B), and 
306(c)(2)(A)(ii) of the FD&C Act, (21 U.S.C. 321(dd), 335a(c)(1)(B), 
and 335a(c)(2)(A)(ii)). Any person with an approved or pending drug 
product application who knowingly employs or retains as a consultant or 
contractor, or otherwise uses the services of Wesley A. McQuerry, in 
any capacity during his 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 Mr. McQuerry provides services in any capacity to a person with an 
approved or pending drug product application during his period of 
debarment, 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 from Wesley A. McQuerry during 
his period of debarment (section 306(c)(1)(B) of the FD&C Act.
    Any application by Mr. McQuerry for special termination of 
debarment under section 306(d)(4) of the FD&C Act should be identified 
with Docket No. FDA-2015-N-3225 and sent to the Division of Dockets 
Management (see ADDRESSES). All such submissions are to be filed in 
four copies. The public availability of information in these 
submissions is governed by 21 CFR 10.20.
    Publicly available submissions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 11, 2016.
Armando Zamora,
Deputy Director, Office of Enforcement and Import Operations, Office of 
Regulatory Affairs.
[FR Doc. 2016-06104 Filed 3-17-16; 8:45 am]
BILLING CODE 4164-01-P

14862 Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN—(CBER) 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

320.31(d) Bioavailability and Bioequivalence Safety Re-
ports .................................................................................. 1 1 1 14 14
312.32(c)(1)(ii) and (c)(1)(iii) IND Safety Reports ............... 137 4 548 12 6,576
312.32(c)(1)(iv) IND Safety Reports .................................... 5 1.4 7 12 84

Total (CBER) ................................................................ ........................ ........................ ........................ ........................ 6,674
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: March 14, 2016. Enforcement, Office of Enforcement and unlawful to provide false information to
Leslie Kux, Import Operations, Office of Regulatory the pharmaceutical company.
Associate Commissioner for Policy. Affairs, Food and Drug Administration, Beginning no later than January 2008,
[FR Doc. 2016–06128 Filed 3–17–16; 8:45 am] 12420 Parklawn Dr., Rockville, MD and continuing through at least October
BILLING CODE 4164–01–P
20857, 301–796–4640. 2008, in the Northern District of Illinois,
SUPPLEMENTARY INFORMATION:
Mr. McQuerry knowingly and willfully
falsified, concealed, and covered up by
DEPARTMENT OF HEALTH AND I. Background trick, scheme, and device material facts
HUMAN SERVICES in a matter within the jurisdiction of
Section 306(a)(2)(A) of the FD&C Act FDA, namely that at least four patients
Food and Drug Administration (21 U.S.C. 335a(a)(2)(A)) requires and others were participating in the
debarment of an individual if FDA finds drug clinical trial, when in fact these
[Docket No. FDA–2015–N–3225] that the individual has been convicted patients did not participate in that
of a felony under Federal law for clinical trial. Specifically, between
Wesley A. McQuerry: Debarment Order
conduct relating to the development or January and October 2008, Mr.
AGENCY: Food and Drug Administration, approval, including the process for McQuerry created fifteen to twenty
HHS. development or approval, of any drug fictional patients, whom he claimed
ACTION: Notice. product. Section 306(a)(2)(B) of the were participants in the clinical trial.
FD&C Act requires debarment of an Mr. McQuerry falsified signatures of
SUMMARY: The U.S. Food and Drug individual if FDA finds that the those patients on consent forms and
Administration (FDA or Agency) is individual has been convicted of a falsified doctors’ signatures on medical
issuing an order under the Federal felony under Federal law for conduct evaluations for those patients. He
Food, Drug, and Cosmetic Act (the otherwise relating to the regulation of provided his own blood, stool, and EKG
FD&C Act) permanently debarring any drug product under the FD&C Act. results, which he claimed were
Wesley A. McQuerry from providing On February 10, 2015, the U.S. District provided by the fictional patients. He
services in any capacity to a person that Court for the Northern District of Illinois also transmitted false data and
has an approved or pending drug entered judgment against Mr. McQuerry information to the administrator
product application. FDA bases this for one count of falsifying a material regarding these fictional patients and
order on a finding that Mr. McQuerry fact, in violation of 18 U.S.C. 1001(a)(1). made and caused to be made false
was convicted of a felony under Federal The factual basis for this conviction is statements regarding their participation
law for conduct relating to the as follows: Mr. McQuerry was the study in the study and attendance at office
development or approval, including the coordinator for a drug clinical trial at an visits, all of which he knew would be
process for development or approval, of institution in the Northern District of provided to the pharmaceutical
a drug product and otherwise relating to Illinois. The clinical trial occurred company and to FDA.
the regulation of a drug product under under the authority of FDA, and clinical Mr. McQuerry made false statements
the FD&C Act. Mr. McQuerry was given trial data was required to be submitted to the administrator about the
notice of the proposed permanent to FDA before the drug could be whereabouts of the fictitious trial
debarment and an opportunity to approved for sale in the United States. participants. In particular, on August
request a hearing within the timeframe
As study coordinator, Mr. McQuerry’s 28, 2008, he provided false and
prescribed by regulation. Mr. McQuerry
responsibilities for administering the fraudulent statements to the
failed to respond. Mr. McQuerry’s
clinical trial included, among other administrator regarding the attendance
failure to respond constitutes a waiver
things, coordinating patient visits, of two patients at study visits, knowing
of his right to a hearing concerning this
maintaining patient files, ensuring that that the two patients were not in fact
action.
administrative procedures were enrolled in the study and did not attend
DATES: This order is effective March 18, a single study visit.
followed regarding the collection of
2016. patient data, disbursing American As study coordinator, Mr. McQuerry
asabaliauskas on DSK3SPTVN1PROD with NOTICES

ADDRESSES: Submit applications for Express gift checks to trial participants, was responsible for disbursing gift
special termination of debarment to the and transmitting clinical trial data from checks, which were provided by the
Division of Dockets Management (HFA– the institution to the administrator, pharmaceutical company to patients at
305), Food and Drug Administration, which was administering the clinical various points during the patients’
5630 Fishers Lane, Rm. 1061, Rockville, trial on behalf of the pharmaceutical participation in the clinical trial. Mr.
MD 20852. company. Mr. McQuerry knew that the McQuerry falsely and fraudulently
FOR FURTHER INFORMATION CONTACT: results of the clinical trial would be claimed to have disbursed gift checks
Kenny Shade, (ELEM–4144), Division of reported to FDA, and he knew it was when, in fact, no checks were disbursed

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Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices 14863

to patients. Instead, between approved or pending drug product Agenda: The Committee serves to advise
approximately July 11, 2008 and application who knowingly employs or and make recommendations to the Director,
September 3, 2008, Mr. McQuerry retains as a consultant or contractor, or Office of Research on Women’s Health
deposited over $2,300 of gift checks into otherwise uses the services of Wesley A. (ORWH) on a broad range of topics.
Information is also available on the
his personal bank account. He McQuerry, in any capacity during his Institute’s/Center’s home page: http://orwh.
additionally used the gift checks to debarment, will be subject to civil od.nih.gov/about/acrwh/index.asp where an
make direct purchases at various money penalties (section 307(a)(6) of the agenda and any additional information for
retailers. Mr. McQuerry’s fraud resulted FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. the meeting will be posted when available.
in a loss of approximately $200,098 to McQuerry provides services in any Place: National Institutes of Health,
the pharmaceutical company. capacity to a person with an approved Building 31, Room 6C, 31 Center Drive,
As a result of this conviction, FDA or pending drug product application Bethesda, MD 20892.
sent Mr. McQuerry by certified mail on during his period of debarment, he will Contact Person: Terri L. Cornelison, MD,
October 30, 2015, a notice proposing to be subject to civil money penalties Ph.D., Associate Director for Clinical
permanently debar him from providing (section 307(a)(7) of the FD&C Act). In Research, Office of Research on Women’s
services in any capacity to a person that Health, Office of the Director, 6707
addition, FDA will not accept or review Democracy Blvd., Bethesda, MD 20817, 301–
has an approved or pending drug any abbreviated new drug applications 402–1770, cornelit@od.nih.gov.
product application. The proposal was from Wesley A. McQuerry during his
based on a finding, under section Any interested person may file written
period of debarment (section comments with the committee by forwarding
306(a)(2)(A) and (a)(2)(B) of the FD&C 306(c)(1)(B) of the FD&C Act. the statement to the Contact Person listed on
Act, that Mr. McQuerry was convicted Any application by Mr. McQuerry for this notice. The statement should include the
of a felony under Federal law for special termination of debarment under name, address, telephone number and when
conduct relating to the development or section 306(d)(4) of the FD&C Act applicable, the business or professional
approval, including the process for should be identified with Docket No. affiliation of the interested person.
development or approval, of a drug FDA–2015–N–3225 and sent to the In the interest of security, NIH has
product, and conduct otherwise relating Division of Dockets Management (see instituted stringent procedures for entrance
to the regulation of a drug product ADDRESSES). All such submissions are to
onto the NIH campus. All visitor vehicles,
under the FD&C Act. The proposal also including taxicabs, hotel, and airport shuttles
be filed in four copies. The public will be inspected before being allowed on
offered Mr. McQuerry an opportunity to availability of information in these campus. Visitors will be asked to show one
request a hearing, providing him 30 submissions is governed by 21 CFR form of identification (for example, a
days from the date of receipt of the letter 10.20. government-issued photo ID, driver’s license,
in which to file the request, and advised Publicly available submissions may or passport) and to state the purpose of their
him that failure to request a hearing be seen in the Division of Dockets visit.
constituted a waiver of the opportunity Management between 9 a.m. and 4 p.m., Information is also available on the
for a hearing and of any contentions Monday through Friday. Institute’s/Center’s home page:
concerning this action. Mr. McQuerry www4.ordh.od.nih.gov/, where an agenda
Dated: March 11, 2016. and any additional information for the
did not request a hearing and has,
therefore, waived his opportunity for a Armando Zamora, meeting will be posted when available.
hearing and any contentions concerning Deputy Director, Office of Enforcement and (Catalogue of Federal Domestic Assistance
his debarment (21 CFR part 12). Import Operations, Office of Regulatory Program Nos. 93.14, Intramural Research
Affairs. Training Award; 93.22, Clinical Research
II. Findings and Order [FR Doc. 2016–06104 Filed 3–17–16; 8:45 am] Loan Repayment Program for Individuals
Therefore, the Director, Office of BILLING CODE 4164–01–P from Disadvantaged Backgrounds; 93.232,
Enforcement and Import Operations, Loan Repayment Program for Research
Generally; 93.39, Academic Research
Office of Regulatory Affairs, under Enhancement Award; 93.936, NIH Acquired
sections 306(a)(2)(A) and (a)(2)(B) of the DEPARTMENT OF HEALTH AND
Immunodeficiency Syndrome Research Loan
FD&C Act, under authority delegated to HUMAN SERVICES Repayment Program; 93.187, Undergraduate
him (Staff Manual Guide 1410.35), finds Scholarship Program for Individuals from
that Wesley A. McQuerry has been National Institutes of Health Disadvantaged Backgrounds, National
convicted of a felony under Federal law Institutes of Health, HHS)
Office of the Director, National
for conduct relating to the development Dated: March 14, 2016.
Institutes of Health; Notice of Meeting
or approval, including the process for Carolyn Baum,
development or approval, of a drug Pursuant to section 10(a) of the
Program Analyst, Office of Federal Advisory
product and conduct otherwise relating Federal Advisory Committee Act, as Committee Policy.
to the regulation of a drug product amended (5 U.S.C. App.), notice is
[FR Doc. 2016–06075 Filed 3–17–16; 8:45 am]
under the FD&C Act. hereby given of a meeting of the
BILLING CODE 4140–01–P
As a result of the foregoing finding, Advisory Committee on Research on
Wesley A. McQuerry is permanently Women’s Health.
debarred from providing services in any The meeting will be open to the
DEPARTMENT OF HEALTH AND
capacity to a person with an approved public, with attendance limited to space
HUMAN SERVICES
or pending drug product application available. Individuals who plan to
under sections 505, 512, or 802 of the attend and need special assistance, such
asabaliauskas on DSK3SPTVN1PROD with NOTICES

National Institutes of Health
FD&C Act (21 U.S.C. 355, 360b, or 382), as sign language interpretation or other
or under section 351 of the Public reasonable accommodations, should National Cancer Institute; Notice of
Health Service Act (42 U.S.C. 262), notify the Contact Person listed below Closed Meetings
effective (see DATES) (see section in advance of the meeting.
201(dd), 306(c)(1)(B), and Name of Committee: Advisory Committee Pursuant to section 10(d) of the
306(c)(2)(A)(ii) of the FD&C Act, (21 on Research on Women’s Health. Federal Advisory Committee Act, as
U.S.C. 321(dd), 335a(c)(1)(B), and Date: April 19, 2016. amended (5 U.S.C. App.), notice is
335a(c)(2)(A)(ii)). Any person with an Time: 9:00 a.m. to 4:00 p.m. hereby given of the following meetings.

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Document Created: 2018-02-02 15:13:55
Document Modified: 2018-02-02 15:13:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		This order is effective March 18, 2016.
Contact		Kenny Shade, (ELEM-4144), Division of Enforcement, Office of Enforcement and Import Operations, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-4640.
FR Citation		81 FR 14862

81 FR 14862 - Wesley A. McQuerry: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 53 (March 18, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration