[Federal Register Volume 84, Number 230 (Friday, November 29, 2019)]
[Notices]
[Pages 65825-65826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25824]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-1614]
Tzvi Lexier: Final 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 (FD&C Act) debarring
Tzvi Lexier for a period of 10 years from importing any drug into the
United States. FDA bases this order on a finding that Mr. Lexier was
convicted, as defined in the FD&C Act, of one felony count under
Federal law for conspiracy to smuggle into and distribute within the
United States misbranded drugs and one felony count under Federal law
for unlicensed wholesale distribution of prescription drugs. The
factual basis supporting both felony convictions, as described below,
is conduct relating to the importation into the United States of a drug
or controlled substance. Mr. Lexier was given notice of the proposed
debarment and, in accordance with the FD&C Act, was given an
opportunity to request a hearing to show why he should not be debarred.
As of August 2, 2019 (30 days after receipt of the notice), Mr. Lexier
had not responded. Mr. Lexier's failure to respond and request a
hearing constitutes a waiver of his right to a hearing concerning this
matter.
DATES: This order is applicable November 29, 2019.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857 or at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D))
permits debarment of an individual from importing or offering for
import any drug into the United States if FDA finds, as required by
section 306(b)(3)(C) of the FD&C Act, that the individual has been
convicted of a felony for conduct relating to the importation into the
United States of any drug or controlled substance. On January 18, 2019,
Mr. Lexier was convicted as defined in section 306(l)(1)(B) of the FD&C
Act, in the United States District Court for the Eastern District of
Virginia, when the court accepted his plea of guilty and entered
judgment against him for the offenses of conspiracy in violation of 18
U.S.C. 371 and unlicensed wholesale distribution of prescription drugs
in violation of section 301(t) of the FD&C Act (21 U.S.C. 331(t)).
FDA's finding that debarment is appropriate is based on the felony
convictions referenced herein. The factual basis for these convictions
is as follows: As contained in the Stipulation of Facts incorporated
into the Plea Agreement, filed on October 25, 2018, from on or about
April 2011 to December 2014, Tzivi Lexier conspired with certain other
named individuals to smuggle into and distribute within the United
States, on multiple occasions, misbranded drugs. During this time, Mr.
Lexier served as a principal of SB Medical and TC Medical. In that
role, he coordinated the supply of drugs from foreign countries
ultimately intended for the illegal importation into and sale inside
the United States. The misbranded and unapproved prescription drugs
smuggled and sold in the United States by the conspiracy include:
Aclasta; Mabthera; and Bonviva, as well as foreign, unapproved versions
of FDA-approved drug products Actemra; Botox; Botox Cosmetic; Dysport;
Lucentis; Orencia; Prolia; Remicade; and, Zometa.
As a result of this conviction, FDA sent Mr. Lexier by certified
mail on June 24, 2019, a notice proposing to debar him for two
consecutive 5-year periods (10 years) from importing or offering for
import any drug into the United States The proposal was based on a
finding under section 306(b)(3)(C) of the FD&C Act that Mr. Lexier's
felony convictions for conspiracy in violation of 18 U.S.C. 371 and
unlicensed wholesale distribution of prescription drugs in violation of
section 301(t) of the FD&C Act were for conduct relating to the
importation into the United States of any drug or controlled substance
because he conspired with others to smuggle into and distribute within
the United States, on multiple occasions, misbranded drugs. In
proposing a debarment period, FDA weighed the considerations set forth
in section 306(c)(3) of the FD&C Act that it considered applicable to
Mr. Lexier's offenses, concluded that each of these felony offenses
independently warranted a five-year period of
[[Page 65826]]
debarment, and proposed that these debarment periods be served
consecutively under section 306(c)(2)(A)(iii).
The proposal informed Mr. Lexier of the proposed debarment and
offered Mr. Lexier 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. Lexier received the proposal and notice of
opportunity for a hearing on July 1, 2019. Mr. Lexier failed to request
a hearing within the timeframe prescribed by regulation and has,
therefore, waived his opportunity for a hearing and waived any
contentions concerning his debarment. (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Lexier has been convicted of two felony counts under Federal law for
conduct relating to the importation into the United States of any drug
or controlled substance. FDA finds that each offense should be accorded
a debarment period of 5 years. Under section 306(c)(2)(A)(iii) of the
FD&C Act, in the case of a person debarred for multiple offenses, FDA
shall determine whether the periods of debarment shall run concurrently
or consecutively. FDA has concluded that the 5-year period of debarment
for each of the two offenses of conviction needs to be served
consecutively, resulting in a total debarment period of 10 years.
As a result of the foregoing finding, Mr. Lexier is debarred for a
period of 10 years from importing or offering for import any drug into
the United States, effective (see DATES). Pursuant to section 301(cc)
of the FD&C Act, the importing or offering for import into the United
States of any drug or controlled substance by, with the assistance of,
or at the direction of Mr. Lexier is a prohibited act.
Any application by Mr. Lexier for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2019-N-1614 and sent to the Dockets Management Staff (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 will be placed in the docket, and
will be viewable at http://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: November 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25824 Filed 11-27-19; 8:45 am]
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