80 FR 39439 - Patricia Durr: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 131 (July 9, 2015)

Page Range		39439-39440
FR Document		2015-16665

The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Patricia Durr 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. Durr was convicted of a felony under Federal law for conduct relating to the regulation of a drug product. Ms. Durr was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Durr failed to request a hearing. Ms. Durr's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.

Federal Register, Volume 80 Issue 131 (Thursday, July 9, 2015)

[Federal Register Volume 80, Number 131 (Thursday, July 9, 2015)]
[Notices]
[Pages 39439-39440]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16665]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2100]


Patricia Durr: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The U.S. Food and Drug Administration (FDA) is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
permanently debarring Patricia Durr 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. Durr was 
convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product. Ms. Durr was given notice of the proposed 
permanent debarment and an opportunity to request a hearing within the 
timeframe prescribed by regulation. Ms. Durr failed to request a 
hearing. Ms. Durr's failure to request a hearing constitutes a waiver 
of her right to a hearing concerning this action.

DATES: This order is effective July 9, 2015.

ADDRESSES: Submit applications for 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, Division of Enforcement, 
Office of Enforcement and Import Operations, Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr. (ELEM-4144), 
Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) 
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 regulation of any drug product under the FD&C Act.
    On April 2, 2014, the U.S. District Court for the Eastern District 
of Virginia entered judgment against Ms. Durr for one count of 
introducing misbranded drugs into interstate commerce with intent to 
defraud or mislead, in violation of sections 301(a) and 303(a)(2) of 
the FD&C Act (21 U.S.C. 331(a) and 333(a)(2)).
    FDA's finding that debarment is appropriate is based on the felony 
conviction referenced herein. The factual basis for this conviction is 
as follows: Ms. Durr was a sales representative for Gallant Pharma 
International Inc. (Gallant Pharma) between October 2010 and August 
2013, and was responsible for selling injectable cosmetic drugs and 
devices, and intravenous chemotherapy drugs, to doctors and hospitals 
in Massachusetts and Connecticut. Some of the drugs Ms. Durr 
facilitated the sale of were misbranded within the meaning of the FD&C 
Act.
    Ms. Durr admitted that she sold drugs which were not approved by 
the FDA for use on patients in the United States. She further admitted 
that the drugs she sold on behalf of Gallant Pharma were misbranded in 
that they did not bear adequate directions for use and were not subject 
to an exemption from that requirement, and they were accompanied by 
non-FDA approved packaging and inserts.
    Between August 2012 and August 2013, Ms. Durr admitted to selling 
more than $699,000 in misbranded drugs and devices to doctors and 
medical practices in Massachusetts and Connecticut. She further 
admitted that the loss amount attributable to her personal sales, under 
U.S. Sentencing Guidelines, was between $400,000 and $1,000,000.
    Between October 2010 and August 2013, Ms. Durr personally sold 
misbranded drugs to 33 distinct doctors and medical practices, and 
generated more than $2.6 million in illegal proceeds from these sales. 
She admitted that, as of August 2012, she became willfully blind to the 
illegality of Gallant Pharma's business. Nonetheless, she continued her 
sales activity with Gallant Pharma until her arrest in August 2013.
    As a result of her conviction, on March 9, 2015, FDA sent Ms. Durr 
a notice by certified mail proposing to permanently debar her from 
providing services in any capacity to a person that has an approved or 
pending drug product application. The proposal was based on the 
finding, under section 306(a)(2)(B) of the FD&C Act, that Ms. Durr was 
convicted of a felony under Federal law for conduct related to the 
regulation of a drug product. FDA determined that Ms. Durr's felony 
conviction was related to the regulation of drug products because the 
conduct underlying her conviction undermined FDA's regulatory oversight 
over drug products marketed in the United States by intentionally 
introducing into interstate commerce drug products that did not bear 
adequate directions for use and were not subject to an exemption from 
that requirement, and which, among other things, were accompanied by 
non-FDA approved packaging and inserts. The proposal also offered Ms. 
Durr an opportunity to request a hearing, providing her 30 days from 
the date of receipt of the letter in which to file the request, and 
advised her that failure to request a hearing constituted a waiver of 
the opportunity for a hearing and of any contentions concerning this 
action. The proposal was received on March 24, 2015. Ms. Durr failed to 
respond within the timeframe prescribed by regulation and has, 
therefore, waived her opportunity for a hearing and has waived any 
contentions concerning her debarment (21 CFR part 12).

[[Page 39440]]

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import 
Operations, Office of Regulatory Affairs, under section 306(a)(2)(B) of 
the FD&C Act, under authority delegated to the Director (Staff Manual 
Guide 1410.35), finds that Patricia Durr has been convicted of a felony 
under federal law for conduct relating to the regulation of a drug 
product. Section 306(c)(2)(A)(ii) of the FD&C Act (21 U.S.C. 
335a(c)(2)(A)(ii)) requires that Ms. Durr's debarment be permanent.
    As a result of the foregoing findings, Patricia Durr 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 Patricia Durr, in any capacity during 
her 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. Durr provides 
services in any capacity to a person with an approved or pending drug 
product application during her period of debarment she will be subject 
to civil money penalties (section 307(a)(7) of the FD&C Act (21 U.S.C. 
335b(a)(7))). In addition, FDA will not accept or review any 
abbreviated new drug applications submitted by or with the assistance 
of Patricia Durr during her period of debarment (section 306(c)(1)(A) 
of the FD&C Act (21 U.S.C. 335a(c)(1)(A))).
    Any application by Ms. Durr for special termination of debarment 
under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) should 
be identified with Docket No. FDA-2014-N-2100 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: June 25, 2015.
Douglas Stearn,
Director, Division of Compliance Policy, Office of Enforcement, Office 
of Regulatory Affairs.
[FR Doc. 2015-16665 Filed 7-8-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 131 / Thursday, July 9, 2015 / Notices 39439

Agency’s current thinking on meetings pending drug product application. FDA misbranded in that they did not bear
with OOPD. It does not create or confer bases this order on a finding that Ms. adequate directions for use and were not
any rights for or on any person and does Durr was convicted of a felony under subject to an exemption from that
not operate to bind FDA or the public. Federal law for conduct relating to the requirement, and they were
An alternative approach may be used if regulation of a drug product. Ms. Durr accompanied by non-FDA approved
such approach satisfies the was given notice of the proposed packaging and inserts.
requirements of the applicable statutes permanent debarment and an Between August 2012 and August
and regulations. opportunity to request a hearing within 2013, Ms. Durr admitted to selling more
the timeframe prescribed by regulation. than $699,000 in misbranded drugs and
II. Paperwork Reduction Act of 1995
Ms. Durr failed to request a hearing. Ms. devices to doctors and medical practices
This guidance contains information Durr’s failure to request a hearing in Massachusetts and Connecticut. She
collection provisions that are subject to constitutes a waiver of her right to a further admitted that the loss amount
review by the Office of Management and hearing concerning this action. attributable to her personal sales, under
Budget (OMB) under the Paperwork DATES: This order is effective July 9, U.S. Sentencing Guidelines, was
Reduction Act of 1995 (44 U.S.C. 3501– 2015. between $400,000 and $1,000,000.
3520). The collections of information in Between October 2010 and August
ADDRESSES: Submit applications for
this guidance were approved under 2013, Ms. Durr personally sold
OMB control numbers 0910–0167, termination of debarment to the
Division of Dockets Management (HFA– misbranded drugs to 33 distinct doctors
0910–0332, and 0910–0787. and medical practices, and generated
305), Food and Drug Administration,
III. Comments 5630 Fishers Lane, Rm. 1061, Rockville, more than $2.6 million in illegal
MD 20852. proceeds from these sales. She admitted
Interested persons may submit either
FOR FURTHER INFORMATION CONTACT:
that, as of August 2012, she became
electronic comments regarding this
Kenny Shade, Division of Enforcement, willfully blind to the illegality of
document to http://www.regulations.gov
Office of Enforcement and Import Gallant Pharma’s business. Nonetheless,
or written comments to the Division of
Operations, Office of Regulatory Affairs, she continued her sales activity with
Dockets Management (see ADDRESSES). It
Food and Drug Administration, 12420 Gallant Pharma until her arrest in
is only necessary to send one set of
Parklawn Dr. (ELEM–4144), Rockville, August 2013.
comments. Identify comments with the
docket number found in brackets in the MD 20857, 301–796–4640. As a result of her conviction, on
heading of this document. Received SUPPLEMENTARY INFORMATION:
March 9, 2015, FDA sent Ms. Durr a
comments may be seen in the Division notice by certified mail proposing to
I. Background permanently debar her from providing
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and Section 306(a)(2)(B) of the FD&C Act services in any capacity to a person that
will be posted to the docket at http:// (21 U.S.C. 335a(a)(2)(B)) requires has an approved or pending drug
www.regulations.gov. debarment of an individual if FDA finds product application. The proposal was
that the individual has been convicted based on the finding, under section
IV. Electronic Access of a felony under Federal law for 306(a)(2)(B) of the FD&C Act, that Ms.
Persons with access to the Internet conduct relating to the regulation of any Durr was convicted of a felony under
may obtain the document at either drug product under the FD&C Act. Federal law for conduct related to the
http://www.fda.gov/ On April 2, 2014, the U.S. District regulation of a drug product. FDA
RegulatoryInformation/Guidances/ Court for the Eastern District of Virginia determined that Ms. Durr’s felony
default.htm or at http:// entered judgment against Ms. Durr for conviction was related to the regulation
www.regulations.gov. one count of introducing misbranded of drug products because the conduct
drugs into interstate commerce with underlying her conviction undermined
Dated: July 2, 2015.
intent to defraud or mislead, in FDA’s regulatory oversight over drug
Leslie Kux, products marketed in the United States
violation of sections 301(a) and
Associate Commissioner for Policy. by intentionally introducing into
303(a)(2) of the FD&C Act (21 U.S.C.
[FR Doc. 2015–16773 Filed 7–8–15; 8:45 am] interstate commerce drug products that
331(a) and 333(a)(2)).
BILLING CODE 4164–01–P FDA’s finding that debarment is did not bear adequate directions for use
appropriate is based on the felony and were not subject to an exemption
conviction referenced herein. The from that requirement, and which,
DEPARTMENT OF HEALTH AND factual basis for this conviction is as among other things, were accompanied
HUMAN SERVICES follows: Ms. Durr was a sales by non-FDA approved packaging and
representative for Gallant Pharma inserts. The proposal also offered Ms.
Food and Drug Administration
International Inc. (Gallant Pharma) Durr an opportunity to request a
[Docket No. FDA–2014–N–2100] between October 2010 and August 2013, hearing, providing her 30 days from the
and was responsible for selling date of receipt of the letter in which to
Patricia Durr: Debarment Order injectable cosmetic drugs and devices, file the request, and advised her that
AGENCY: Food and Drug Administration, and intravenous chemotherapy drugs, to failure to request a hearing constituted
HHS. doctors and hospitals in Massachusetts a waiver of the opportunity for a hearing
ACTION: Notice. and Connecticut. Some of the drugs Ms. and of any contentions concerning this
Durr facilitated the sale of were action. The proposal was received on
srobinson on DSK5SPTVN1PROD with NOTICES

SUMMARY: The U.S. Food and Drug misbranded within the meaning of the March 24, 2015. Ms. Durr failed to
Administration (FDA) is issuing an FD&C Act. respond within the timeframe
order under the Federal Food, Drug, and Ms. Durr admitted that she sold drugs prescribed by regulation and has,
Cosmetic Act (the FD&C Act) which were not approved by the FDA therefore, waived her opportunity for a
permanently debarring Patricia Durr for use on patients in the United States. hearing and has waived any contentions
from providing services in any capacity She further admitted that the drugs she concerning her debarment (21 CFR part
to a person that has an approved or sold on behalf of Gallant Pharma were 12).

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39440 Federal Register / Vol. 80, No. 131 / Thursday, July 9, 2015 / Notices

II. Findings and Order Dated: June 25, 2015. assist that office in processing your
Douglas Stearn, request.
Therefore, the Director, Office of Director, Division of Compliance Policy,
Enforcement and Import Operations, Submit electronic comments on the
Office of Enforcement, Office of Regulatory draft guidance to http://
Office of Regulatory Affairs, under Affairs.
www.regulations.gov. Submit written
section 306(a)(2)(B) of the FD&C Act, [FR Doc. 2015–16665 Filed 7–8–15; 8:45 am]
comments to the Division of Dockets
under authority delegated to the BILLING CODE 4164–01–P Management (HFA–305), Food and Drug
Director (Staff Manual Guide 1410.35),
Administration, 5630 Fishers Lane, Rm.
finds that Patricia Durr has been 1061, Rockville, MD 20852. Identify
convicted of a felony under federal law DEPARTMENT OF HEALTH AND
comments with the docket number
for conduct relating to the regulation of HUMAN SERVICES
found in brackets in the heading of this
a drug product. Section 306(c)(2)(A)(ii) document.
of the FD&C Act (21 U.S.C. Food and Drug Administration
335a(c)(2)(A)(ii)) requires that Ms. [Docket No. FDA–2015–D–2167] FOR FURTHER INFORMATION CONTACT:
Durr’s debarment be permanent. Angela Krueger, Center for Devices and
Heparin-Containing Medical Devices Radiological Health, Food and Drug
As a result of the foregoing findings, Administration, 10903 New Hampshire
and Combination Products:
Patricia Durr is permanently debarred Ave., Bldg. 66, Rm. 1666, Silver Spring,
Recommendations for Labeling and
from providing services in any capacity MD 20993–0002, 301–796–6380.
Safety Testing; Draft Guidance for
to a person with an approved or Industry and Food and Drug
pending drug product application under SUPPLEMENTARY INFORMATION:
Administration Staff; Availability
sections 505, 512, or 802 of the FD&C I. Background
Act (21 U.S.C. 355, 360b, or 382), or AGENCY: Food and Drug Administration,
under section 351 of the Public Health HHS. The USP 1 heparin monographs have
Service Act (42 U.S.C. 262), effective ACTION: Notice. recently undergone several revisions
(see DATES) (see section 201(dd), following serious and fatal events
306(c)(1)(B), and 306(c)(2)(A)(ii) of the SUMMARY: The Food and Drug related to the use of heparin sodium
FD&C Act (21 U.S.C. 321(dd), Administration (FDA) is announcing the products. Investigation of heparin
335a(c)(1)(B), and 335a(c)(2)(A)(ii)). Any availability of the draft guidance product overdose errors identified the
person with an approved or pending entitled ‘‘Heparin-Containing Medical expression of drug strength in the labels
Devices and Combination Products: as a major contributing factor in these
drug product application who
Recommendations for Labeling and errors. This draft guidance document is
knowingly employs or retains as a
Safety Testing.’’ This draft guidance intended to address these safety
consultant or contractor, or otherwise describes FDA’s intent to address the
uses the services of Patricia Durr, in any concerns by clarifying new expectations
safety concerns by clarifying new for labeling with regard to the soon-to-
capacity during her debarment, will be expectations for labeling with regard to
subject to civil money penalties (section be revised heparin USP monographs
the soon-to-be revised heparin United (USP36–NF31),2 as well as outline
307(a)(6) of the FD&C Act (21 U.S.C. States Pharmacopeia (USP) monographs
335b(a)(6))). If Ms. Durr provides safety testing recommendations.
as well as outline safety testing
services in any capacity to a person with recommendations. This draft guidance In addition, the outbreak of serious
an approved or pending drug product is not final nor is it in effect at this time. and often fatal events due to heparin
application during her period of contamination with over-sulfated
DATES: Although you can comment on
debarment she will be subject to civil chondroitin sulfate in 2008 led the USP
any guidance at any time (see 21 CFR
money penalties (section 307(a)(7) of the to include in its monograph additional
10.115(g)(5)), to ensure that the Agency
FD&C Act (21 U.S.C. 335b(a)(7))). In testing of heparin source material to
considers your comment on this draft
addition, FDA will not accept or review ensure its quality and purity. This draft
guidance before it begins work on the
any abbreviated new drug applications guidance also outlines use of
final version of the guidance, submit
submitted by or with the assistance of conformance to the monograph in
either electronic or written comments
Patricia Durr during her period of on the draft guidance by October 7, premarket submissions, specifically
debarment (section 306(c)(1)(A) of the 2015. testing and documentation requirements
and recommendations contained in the
FD&C Act (21 U.S.C. 335a(c)(1)(A))). ADDRESSES: An electronic copy of the current USP monograph, and the
Any application by Ms. Durr for guidance document is available for guidance document ‘‘Heparin for Drug
special termination of debarment under download from the Internet. See the and Medical Device Use: Monitoring
section 306(d)(4) of the FD&C Act (21 SUPPLEMENTARY INFORMATION section for Crude Heparin for Quality’’ (http://
U.S.C. 335a(d)(4)) should be identified information on electronic access to the www.fda.gov/downloads/Drugs/
with Docket No. FDA–2014–N–2100 guidance. Submit written requests for GuidanceComplianceRegulatory
and sent to the Division of Dockets single copies of the draft guidance
Management (see ADDRESSES). All such document entitled ‘‘Heparin-Containing 1 USP is a scientific nonprofit organization that

submissions are to be filed in four Medical Devices and Combination develops standards for the identity, strength,
copies. The public availability of Products: Recommendations for quality, and purity of drugs and drug ingredients
Labeling and Safety Testing’’ to the marketed in the United States. These standards are
srobinson on DSK5SPTVN1PROD with NOTICES

information in these submissions is published in USP’s official compendia, ‘‘United
governed by 21 CFR 10.20. Office of the Center Director, Guidance States Pharmacopeia and National Formulary.’’
and Policy Development, Center for 2 USP monograph, USP PF 38 (3) and (5) Interim
Publicly available submissions may Devices and Radiological Health, Food Revision Announcement, with proposed effective
be seen in the Division of Dockets and Drug Administration, 10903 New revision date of May 1, 2013. See also ‘‘FDA Drug
Management between 9 a.m. and 4 p.m., Safety Communication: Important Change to
Hampshire Ave., Bldg. 66, Rm. 5431, Heparin Container Labels to Clearly State the Total
Monday through Friday. Silver Spring, MD 20993–0002. Send Drug Strength’’ at http://www.fda.gov/Drugs/
one self-addressed adhesive label to DrugSafety/ucm330695.htm.

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Document Created: 2018-02-23 09:14:11
Document Modified: 2018-02-23 09:14:11

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 July 9, 2015.
Contact		Kenny Shade, Division of Enforcement, Office of Enforcement and Import Operations, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr. (ELEM-4144), Rockville, MD 20857, 301-796-4640.
FR Citation		80 FR 39439

80 FR 39439 - Patricia Durr: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 131 (July 9, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration