[Federal Register Volume 75, Number 67 (Thursday, April 8, 2010)]
[Notices]
[Pages 17927-17928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0286]


Kevin Xu: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (the act) permanently 
debarring Kevin Xu 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. Xu was convicted of a felony under 
Federal law for conduct relating to the regulation of a drug product 
under the act. Mr. Xu was given notice of the proposed permanent 
debarment and an opportunity to request a hearing within the timeframe 
prescribed by regulation. As of September 23, 2009, Mr. Xu has failed 
to respond. Mr. Xu's failure to respond constitutes a waiver of his 
right to a hearing concerning this action.

DATES: This order is effective April 8, 2010.

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, Division of Compliance 
Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
240-632-6844.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the 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 otherwise relating 
to the regulation of any drug product under the act.
    On January 20, 2009, the U.S. District Court for the Southern 
District of Texas entered judgment against Mr. Xu for one count of 
participating in a conspiracy to traffic and attempt to traffic in 
counterfeit goods, to cause the introduction and delivery for 
introduction of misbranded prescription drugs into interstate commerce, 
and to cause the counterfeiting of trademarks in violation of 18 U.S.C. 
371, three counts of causing the introduction and delivery for 
introduction of misbranded prescription drugs into interstate commerce 
in violation of 21 U.S.C. 331(a) and 21 U.S.C. 333(a)(2), and one count 
of trafficking in counterfeit goods

[[Page 17928]]

in violation of 18 U.S.C. 2320(a) and 18 U.S.C. 2320(a)(2).
    FDA's finding that debarment is appropriate is based on the felony 
convictions referenced herein for conduct relating to the regulation of 
a drug product. The factual basis for those convictions is as follows: 
From July 2006 until on or about July 2007, Mr. Xu did knowingly, 
intentionally, and willfully conspire and agree with other persons to 
import pharmaceutical drug products that bore the trademarks ZYPREXA, 
TAMIFLU, CASODEX, PLAVIX, and ARICEPT without the authorization of the 
manufacturer of these drugs, and then to resell these products to the 
public.
    On or about December 8, 2007, Mr. Xu used an Internet email address 
to send an email listing the tracking numbers connected to the sale of 
counterfeit pharmaceuticals. On or about April 9, 2007, Mr. Xu caused 
coconspirators residing in the Republic of China to place in interstate 
commerce for shipment to the United States various blister strips 
containing counterfeit TAMIFLU, CASODEX, ZYPREXA, and PLAVIX.
    On or about December 8, 2006, with the intent to defraud or 
mislead, Mr. Xu caused the introduction and delivery for introduction 
into interstate commerce of drugs that were misbranded, namely a 
shipment containing blister strips of TAMIFLU capsules that were 
labeled in a manner to falsely represent that these blister strips 
contained genuine TAMIFLU.
    On or about January 3, 2007, with the intent to defraud or mislead, 
Mr. Xu caused introduction and delivery for introduction into 
interstate commerce of drugs that were misbranded, namely a shipment 
containing blister strips of ZYPREXA pills that were labeled in a 
manner to falsely represent that these blister strips contained genuine 
ZYPREXA.
    On or about February 20, 2007, with the intent to defraud or 
mislead, Mr. Xu caused the introduction and delivery for introduction 
into interstate commerce of drugs that were misbranded, namely a 
shipment containing blister strips of PLAVIX pills that were labeled in 
a manner to falsely represent that these blister strips contained 
genuine PLAVIX.
    On or about December 8, 2006, Mr. Xu intentionally trafficked in 
goods, namely pharmaceutical drugs, and knowingly used a counterfeit 
mark, the ZYPREXA trademark, on and in connection with such goods.
    As a result of his conviction, on August 17, 2009, FDA sent Mr. Xu 
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 a finding, 
under section 306(a)(2)(B) of the act that Kevin Xu was convicted of a 
felony under Federal law for conduct relating to the regulation of a 
drug product under the act. The proposal also offered Mr. Xu 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. Mr. Xu failed to respond within the timeframe prescribed by 
regulation and has, therefore, waived his opportunity for a hearing and 
any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Acting Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(a)(2)(B) of the act, under 
authority delegated to the Acting Director (Staff Manual Guide 
1410.35), finds that Kevin Xu has been convicted of a felony under 
Federal law for conduct relating to the regulation of a drug product 
under the act.
    As a result of the foregoing finding, Mr. Xu 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 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 306(c)(1)(B) and (c)(2)(A)(ii) and section 201(dd) of the 
act (21 U.S.C. 321(dd))). 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 Kevin Xu, in any capacity 
during Mr. Xu's debarment, will be subject to civil money penalties 
(section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Mr. Xu 
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 act). In 
addition, FDA will not accept or review any abbreviated new drug 
applications submitted by or with the assistance of Mr. Xu during his 
period of debarment (section 306(c)(1)(B) of the act).
    Any application by Mr. Xu for special termination of debarment 
under section 306(d)(4) of the act should be identified with Docket No. 
FDA-2009-N-0286 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(j).
    Publicly available submissions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 15, 2010.
Brenda Holman,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2010-8023 Filed 4-7-10; 8:45 am]
BILLING CODE 4160-01-S