[Federal Register Volume 80, Number 130 (Wednesday, July 8, 2015)]
[Notices]
[Pages 39121-39122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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