[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Notices]
[Pages 55632-55634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23204]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2102]


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

DATES: This order is effective September 16, 2015.

ADDRESSES: Submit applications for special termination of debarment to 
the Division of Dockets Management (HFA-

[[Page 55633]]

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 May 16, 2014, the U.S. District Court for the Eastern District 
of Virginia entered judgment against Mr. Huda for one count of 
importation contrary to law, in violation of 18 U.S.C. 545 and 2, one 
count of introducing misbranded drugs into interstate commerce, in 
violation of 21 U.S.C. 331(a), 333(a)(2), and 18 U.S.C. 2, one count of 
unlicensed wholesale distribution of prescription drugs, in violation 
of 21 U.S.C. 331(t), 333(b)(1)(D), 353(e)(2)(A), and 18 U.S.C. 2, and 
one count of wire fraud, in violation of 18 U.S.C. 1343.
    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. Huda 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. Huda was primarily 
responsible for the United States based portion of the conspiracy, 
including: (1) Identifying a drop shipper willing to accept illegal 
importations of behalf of Gallant Pharma, (2) locating space for 
Gallant Pharma to store misbranded and non-FDA approved drugs and 
devices, (3) establishing relationships with customers in the 
Washington, DC metropolitan area, (4) interviewing and hiring sales 
representatives in other parts of the United States, and (5) 
establishing merchant accounts with credit card processors, for receipt 
of illegal proceeds via wire transfer into Canadian 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. 
Huda acquired were not approved by the FDA for use on patients in the 
United States. Mr. Huda 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 
Gallant Pharma 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.
    Immediately after establishing Gallant Pharma's presence in the 
Eastern District of Virginia, on or about September 25, 2009, Mr. Huda 
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 Gallant Pharma 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. Huda personally solicited orders on behalf of Gallant Pharma, 
and on or about October 19, 2010, he sold 10 vials of misbranded 
TAXOTERE to a physician in Oceanside, CA, in exchange for $2450, 
thereby causing misbranded drugs to travel in interstate commerce from 
the Eastern District of Virginia. Mr. Huda was aware of several 
occasions in which physicians complained after receiving drugs with 
packaging and inserts written in language other than English, and he 
authorized a price reduction upon receiving such complaints.
    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. Huda 
admitted that he was an organizer or leader of this criminal activity 
and 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 May 20, 2015, FDA sent Mr. Huda 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. Huda was 
convicted of felonies under Federal law for conduct related to the 
regulation of a drug product. The proposal also offered Mr. Huda 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. The proposal was received on May 26, 2015. Mr. Huda 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 Syed Huda 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, Syed Huda 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 Syed Huda, 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. Huda 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 
Syed Huda during his period of debarment (section 306(c)(1)(B) of the 
FD&C Act.
    Any application by Mr. Huda for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No.

[[Page 55634]]

FDA-2014-N-2102 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: September 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23204 Filed 9-15-15; 8:45 am]
 BILLING CODE 4164-01-P