80 FR 39121 - Talib Khan: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 130 (July 8, 2015)

Page Range		39121-39122
FR Document		2015-16664

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 Talib Khan 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. Khan was convicted of two felonies under Federal law for conduct relating to the regulation of a drug product. Mr. Khan was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Khan failed to respond. Mr. Khan's failure to respond constitutes a waiver of his right to a hearing concerning this action.

Federal Register, Volume 80 Issue 130 (Wednesday, July 8, 2015)

[Federal Register Volume 80, Number 130 (Wednesday, July 8, 2015)]
[Notices]
[Pages 39121-39122]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16664]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2103]


Talib Khan: 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 Talib Khan 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. Khan was 
convicted of two felonies under Federal law for conduct relating to the 
regulation of a drug product. Mr. Khan was given notice of the proposed 
permanent debarment and an opportunity to request a hearing within the 
timeframe prescribed by regulation. Mr. Khan failed to respond. Mr. 
Khan's failure to respond constitutes a waiver of his right to a 
hearing concerning this action.

DATES: This order is effective July 8, 2015.

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)(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 March 11, 2014, the U.S. District Court for the Eastern District 
of Virginia entered judgment against Mr. Khan for one count of 
conspiracy in violation of 18 U.S.C. 371, and one count of introducing 
misbranded drugs into interstate commerce, in violation of 21 U.S.C. 
331(a) and 333(a)(2) and 18 U.S.C. 2.
    FDA's finding that debarment is appropriate is based on the felony 
convictions referenced herein. The factual basis for this conviction is 
as follows: Mr. Khan was a cofounder and co-owner of Gallant Pharma 
International Inc. (Gallant Pharma), between August 2009 and August 
2013. Gallant was a company dedicated to the illegal importation and 
sale of misbranded and non-FDA approved chemotherapy drugs and 
injectable cosmetic drugs and devices in the United States.
    As cofounder and co-owner of Gallant Pharma, Mr. Khan was primarily 
responsible for the international aspect of the conspiracy, including: 
(1) Determining which drugs and devices to sell in the United States; 
(2) establishing relationships with international suppliers; (3) 
directing those suppliers to send drugs and devices to transshippers in 
Canada and the United Kingdom; (4) arranging for transshipment from 
Canada and the United Kingdom to the United States; (5) interviewing, 
hiring, and training sales representatives in the United States; (6) 
and paying suppliers, sales representatives, and office employees out 
of foreign bank accounts. Gallant Pharma was not licensed as a 
prescription drug wholesaler by the Commonwealth of Virginia. Some of 
the drugs and devices that Mr. Khan acquired were not approved by the 
FDA for use on patients in the United States. Mr. Khan admitted that 
the drugs sold by Gallant Pharma were prescription only and were 
misbranded in that, among other things, 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. The drugs Mr. Kahn's company sold also lacked the FDA-
required pedigree, which protects patient health by tracking each sale, 
purchase, or trade of a drug from the time of manufacturing to delivery 
to the patient, and some drug packaging and inserts were written solely 
in languages other than English.
    Immediately after establishing Gallant Pharma's presence in the 
Eastern District of Virginia, on or about September 25, 2009, Mr. Khan 
received a cease and desist letter from a law firm on behalf of 
Medicis, the exclusive authorized marketer of Restylane and Perlane in 
the United States and Canada. The letter informed Mr. Khan's company 
that its marketing of these drugs violated the FD&C Act and could 
subject Gallant Pharma to substantial criminal and civil penalties. The 
letter included Gallant Pharma's marketing materials, which falsely 
claimed that Gallant Pharma had been ``strictly working with the 
current FDA rules and regulations for almost 10 years.''
    Mr. Khan purchased drugs and devices from suppliers in, among other 
places, Turkey, Switzerland, the United Kingdom, and the United Arab 
Emirates. In or around March 2011, after a coconspirator's medical 
license had expired, Mr. Khan altered the expiration date on the 
medical license to make it appear that the license was still valid.
    On at least 18 occasions, Mr. Khan personally completed false 
customs declarations and thereby illegally imported misbranded drugs 
and devices from Canada to the Eastern District of Virginia. Mr. Khan 
also personally accepted and processed orders for Gallant Pharma 
customers.
    Between August 2009 and August 2013, Gallant Pharma received 
illegal proceeds of at least $12,400,000 from the sale of misbranded 
and non-FDA approved drugs and devices in the United States. Mr. Khan 
admitted that he was an organizer or leader of this criminal activity 
and he additionally admitted that his actions were in all respects 
knowing, voluntary, and intentional, and did not occur by accident, 
mistake, or for another innocent reason.
    As a result of his conviction, on March 19, 2015, FDA sent Mr. Khan 
a notice by certified mail 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 the 
finding, under section 306(a)(2)(B) of the FD&C Act, that Mr. Khan was 
convicted of felonies under Federal law for conduct related to the 
regulation of a drug product. The proposal also offered Mr. Khan 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

[[Page 39122]]

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 23, 2015. Mr. Khan failed to respond within the 
timeframe prescribed by regulation and has, therefore, waived his 
opportunity for a hearing and has waived 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 section 306(a)(2)(B) of 
the FD&C Act, under authority delegated to him (Staff Manual Guide 
1410.35), finds that Talib Khan has been convicted of felonies under 
Federal law for conduct relating to the regulation of a drug product.
    As a result of the foregoing finding, Talib Khan 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 Talib Khan, 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. Khan 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 (21 U.S.C. 
335b(a)(7))). In addition, FDA will not accept or review any 
abbreviated new drug applications from Talib Khan during his period of 
debarment (section 306(c)(1)(B) of the FD&C Act (21 U.S.C. 
335a(c)(1)(B))).
    Any application by Mr. Khan 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-2103 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. 2015-16664 Filed 7-7-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices 39121

collection of information upon the I. Background time of manufacturing to delivery to the
respondents, including the use of Section 306(a)(2)(B) of the FD&C Act patient, and some drug packaging and
automated collection techniques or (21 U.S.C. 335a(a)(2)(B)) requires inserts were written solely in languages
other forms of information technology. debarment of an individual if FDA finds other than English.
Comments submitted in response to Immediately after establishing Gallant
that the individual has been convicted
this notice will be summarized and Pharma’s presence in the Eastern
of a felony under Federal law for
included in the Agency’s subsequent District of Virginia, on or about
conduct relating to the regulation of any
request for OMB approval of the September 25, 2009, Mr. Khan received
drug product under the FD&C Act.
proposed information collection. All a cease and desist letter from a law firm
On March 11, 2014, the U.S. District
comments will become a matter of on behalf of Medicis, the exclusive
Court for the Eastern District of Virginia
public record. authorized marketer of Restylane and
entered judgment against Mr. Khan for
Perlane in the United States and
Sharon B. Arnold, one count of conspiracy in violation of
Canada. The letter informed Mr. Khan’s
18 U.S.C. 371, and one count of
Deputy Director. company that its marketing of these
introducing misbranded drugs into
[FR Doc. 2015–16646 Filed 7–7–15; 8:45 am] drugs violated the FD&C Act and could
interstate commerce, in violation of 21
BILLING CODE 4160–90–P subject Gallant Pharma to substantial
U.S.C. 331(a) and 333(a)(2) and 18
criminal and civil penalties. The letter
U.S.C. 2.
included Gallant Pharma’s marketing
FDA’s finding that debarment is
DEPARTMENT OF HEALTH AND materials, which falsely claimed that
appropriate is based on the felony
HUMAN SERVICES Gallant Pharma had been ‘‘strictly
convictions referenced herein. The
working with the current FDA rules and
Food and Drug Administration factual basis for this conviction is as
regulations for almost 10 years.’’
follows: Mr. Khan was a cofounder and Mr. Khan purchased drugs and
co-owner of Gallant Pharma devices from suppliers in, among other
[Docket No. FDA–2014–N–2103]
International Inc. (Gallant Pharma), places, Turkey, Switzerland, the United
Talib Khan: Debarment Order between August 2009 and August 2013. Kingdom, and the United Arab
Gallant was a company dedicated to the Emirates. In or around March 2011, after
AGENCY: Food and Drug Administration, illegal importation and sale of a coconspirator’s medical license had
HHS. misbranded and non-FDA approved expired, Mr. Khan altered the expiration
chemotherapy drugs and injectable date on the medical license to make it
ACTION: Notice.
cosmetic drugs and devices in the appear that the license was still valid.
SUMMARY: The U.S. Food and Drug United States. On at least 18 occasions, Mr. Khan
Administration (FDA or Agency) is As cofounder and co-owner of Gallant personally completed false customs
issuing an order under the Federal Pharma, Mr. Khan was primarily declarations and thereby illegally
Food, Drug, and Cosmetic Act (the responsible for the international aspect imported misbranded drugs and devices
FD&C Act) permanently debarring Talib of the conspiracy, including: (1) from Canada to the Eastern District of
Khan from providing services in any Determining which drugs and devices to Virginia. Mr. Khan also personally
capacity to a person that has an sell in the United States; (2) establishing accepted and processed orders for
approved or pending drug product relationships with international Gallant Pharma customers.
application. FDA bases this order on a suppliers; (3) directing those suppliers Between August 2009 and August
finding that Mr. Khan was convicted of to send drugs and devices to 2013, Gallant Pharma received illegal
two felonies under Federal law for transshippers in Canada and the United proceeds of at least $12,400,000 from
conduct relating to the regulation of a Kingdom; (4) arranging for the sale of misbranded and non-FDA
drug product. Mr. Khan was given transshipment from Canada and the approved drugs and devices in the
notice of the proposed permanent United Kingdom to the United States; United States. Mr. Khan admitted that
debarment and an opportunity to (5) interviewing, hiring, and training he was an organizer or leader of this
request a hearing within the timeframe sales representatives in the United criminal activity and he additionally
prescribed by regulation. Mr. Khan States; (6) and paying suppliers, sales admitted that his actions were in all
failed to respond. Mr. Khan’s failure to representatives, and office employees respects knowing, voluntary, and
respond constitutes a waiver of his right out of foreign bank accounts. Gallant intentional, and did not occur by
to a hearing concerning this action. Pharma was not licensed as a accident, mistake, or for another
prescription drug wholesaler by the innocent reason.
DATES: This order is effective July 8, Commonwealth of Virginia. Some of the As a result of his conviction, on
2015. drugs and devices that Mr. Khan March 19, 2015, FDA sent Mr. Khan a
ADDRESSES: Submit applications for acquired were not approved by the FDA notice by certified mail proposing to
special termination of debarment to the for use on patients in the United States. permanently debar him from providing
Division of Dockets Management (HFA– Mr. Khan admitted that the drugs sold services in any capacity to a person that
305), Food and Drug Administration, by Gallant Pharma were prescription has an approved or pending drug
5630 Fishers Lane, Rm. 1061, Rockville, only and were misbranded in that, product application. The proposal was
MD 20852. among other things, they did not bear based on the finding, under section
adequate directions for use and were not 306(a)(2)(B) of the FD&C Act, that Mr.
FOR FURTHER INFORMATION CONTACT: subject to an exemption from that Khan was convicted of felonies under
srobinson on DSK5SPTVN1PROD with NOTICES

Kenny Shade (ELEM–4144), Division of requirement, and they were Federal law for conduct related to the
Enforcement, Office of Enforcement and accompanied by non-FDA approved regulation of a drug product. The
Import Operations, Office of Regulatory packaging and inserts. The drugs Mr. proposal also offered Mr. Khan an
Affairs, Food and Drug Administration, Kahn’s company sold also lacked the opportunity to request a hearing,
12420 Parklawn Dr., Rockville, MD FDA-required pedigree, which protects providing him 30 days from the date of
20857, 301–796–4640. patient health by tracking each sale, receipt of the letter in which to file the
SUPPLEMENTARY INFORMATION: purchase, or trade of a drug from the request, and advised him that failure to

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Document Created: 2018-02-23 09:12:18
Document Modified: 2018-02-23 09:12:18

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 8, 2015.
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		80 FR 39121

80 FR 39121 - Talib Khan: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 130 (July 8, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration