[Federal Register Volume 80, Number 131 (Thursday, July 9, 2015)]
[Notices]
[Pages 39439-39440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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