2010-8023. Kevin Xu: Debarment Order

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 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.