[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14862-14863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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