[Federal Register Volume 85, Number 52 (Tuesday, March 17, 2020)]
[Notices]
[Pages 15190-15191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05449]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3131]


Jagen D. Lewicki: 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 
Jagen Lewicki for a period of 5 years from importing or offering for 
import any drug into the United States. FDA bases this order on a 
finding that Mr. Lewicki was convicted, as defined in the FD&C Act, of 
one felony count under Federal law for conspiracy to distribute Human 
Growth Hormone (HGH) imported from China for a purpose other than the 
treatment of a disease or other recognized medical condition, the use 
of which had been authorized by the Secretary of Health and Human 
Services, and not pursuant to an order of a physician, in violation of 
the FD&C Act. The factual basis supporting this felony conviction, as 
described below, is conduct relating to the importation into the United 
States of a drug or controlled substance. Mr. Lewicki was given notice 
of the proposed debarment and, in accordance with the FD&C Act and 
FDA's regulations, was given an opportunity to request a hearing to 
show why he should not be debarred. As of October 28, 2019 (30 days 
after receipt of the notice), Mr. Lewicki had not responded. Mr. 
Lewicki'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 March 17, 2020.

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 the FDA finds, as required by 
section 306(b)(3)(C) of the FD&C Act, that the individual has

[[Page 15191]]

been convicted of a felony for conduct relating to the importation into 
the United States of any drug or controlled substance.
    On December 20, 2018, Mr. Lewicki 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 for the offense of conspiracy to distribute HGH imported 
from China for unapproved purposes in violation of 18 U.S.C. 371 and 21 
U.S.C. 333(e) (section 303(e) of FD&C Act).
    The FDA's finding that debarment is appropriate is based on the 
felony conviction referenced herein. The factual basis for this 
conviction is as follows: As contained in the Stipulation of Facts 
incorporated into the Plea Agreement, filed on December 20, 2018, from 
on or about January 2017 to February 2018, Mr. Lewicki conspired with 
certain other known and unknown individuals to unlawfully distribute 
HGH imported from China. Specifically, Mr. Lewicki submitted periodic 
orders, and gave money, for HGH to co-conspirators, for the purchase of 
HGH from manufacturers based in China. In addition, Mr. Lewicki set up 
various post office boxes at private carriers in the Eastern District 
of Virginia. The Chinese based manufacturers delivered vials of HGH 
from China to Mr. Lewicki at post office boxes he set up. Mr. Lewicki 
received approximately 90 packages from Chinese manufacturers, each 
containing 200 vials of HGH. Mr. Lewicki would then sell these vials to 
individual customers throughout the United States for bodybuilding and 
other unapproved purposes. Mr. Lewicki's actions were in violation of 
18 U.S.C. 371 and 21 U.S.C. 333(e) (section 303(e) of the FD&C Act).
    As a result of this conviction FDA sent Mr. Lewicki, by certified 
mail on September 25, 2019, a notice proposing to debar him for 5 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. Lewicki's felony conviction for conspiracy in 
violation of 18 U.S.C. 371 and section 303(e) of the FD&C Act was for 
conduct relating to the importation into the United States of any drug 
or controlled substance because on multiple occasions, he imported HGH 
from China and conspired to distribute it within the United States. 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. Lewicki's offense and, for the reasons detailed in the notice, 
concluded that his offense warranted a 5-year period of debarment under 
section 306(c)(2)(A)(iii).
    The proposal informed Mr. Lewicki of the proposed debarment and 
offered Mr. Lewicki 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. Lewicki received the proposal and notice of 
opportunity for a hearing on September 28, 2019. Mr. Lewicki 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. 
Lewicki has been convicted of a felony under Federal law for conduct 
relating to the importation into the United States of any drug or 
controlled substance. FDA finds that the offense should be accorded a 
debarment period of 5 years.
    As a result of the foregoing finding, pursuant to section 
306(b)(1)(D) of the FD&C Act, Mr. Lewicki is debarred for a period of 5 
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 (21 U.S.C. 331(cc)), the importing or offering for import into the 
United States of any drug by, with the assistance of, or at the 
direction of, Mr. Lewicki is a prohibited act.
    Any application by Mr. Lewicki for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2019-N-3131 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.
    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: March 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05449 Filed 3-16-20; 8:45 am]
BILLING CODE 4164-01-P