[Federal Register Volume 85, Number 203 (Tuesday, October 20, 2020)]
[Notices]
[Pages 66568-66569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23135]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1058]


Keith Komar: 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 
Keith Komar 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. Komar was convicted of one felony count under Federal 
law for mail fraud. The factual basis supporting Mr. Komar's 
conviction, as described below, is conduct relating to the importation 
into the United States of a drug or controlled substance. Mr. Komar was 
given notice of the proposed debarment and was given an opportunity to 
request a hearing to show why he should not be debarred. As of 30 days 
after receipt of the notice (July 22, 2020), Mr. Komar had not 
responded. Mr. Komar'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 October 20, 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, 240-402-8743, 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 November 7, 2019, 
Mr. Komar was convicted, as defined in section 306(l)(1) of the FD&C 
Act, in the U.S. District Court for the Western District of 
Pennsylvania, when the court entered judgment against him for the 
felony offense of mail fraud in violation of 18 U.S.C. 1341.
    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 count 3 of the indictment in Mr. Komar's 
case, filed on November 29, 2017, to which Mr. Komar pleaded guilty, on 
or about December 7, 2015, Mr. Komar, for the purpose of executing a 
scheme and artifice to defraud, and in attempting to do so, knowingly 
caused the U.S. mail to deliver from Mumbai, India, a parcel containing 
misbranded drugs. Specifically, the parcel contained 30 tablets of the 
unapproved new prescription drug bicalutamide and 30 gelcaps of the 
unapproved new prescription drug isotretinoin. These drugs were 
misbranded because, as contained in the indictment in Mr. Komar's case, 
they were dispensed to consumers without a valid prescription from a 
practitioner licensed by law to administer such drugs, and they did not 
contain labeling bearing adequate directions for use. As detailed in 
facts contained in counts 1, 2, and 4 of Mr. Komar's indictment (facts 
which Mr. Komar acknowledged responsibility for in his plea agreement), 
Mr. Komar was part of a criminal conspiracy. As part of this criminal 
conspiracy, Mr. Komar's intent was to fraudulently import this 
misbranded bicalutamide and isotretinoin and sell them in interstate 
commerce to customers of Mr. Komar's websites. On these websites Mr. 
Komar made a number of false statements to potential customers, such as 
that he provided ``high quality, safe, and approved medications meeting 
or exceeding the U.S. FDA standard.'' In addition, Mr. Komar later did 
in fact cause the introduction and delivery for introduction of 
misbranded drugs (bicalutamide and isotretinoin) into interstate 
commerce with the intent to defraud and mislead by selling these 
unapproved new prescription drugs to a

[[Page 66569]]

customer who did not have a prescription for them. A member of the 
conspiracy caused the customs declaration on the parcel to falsely 
report that the parcel contained a health product sample with no 
declared value.
    As a result of this conviction, FDA sent Mr. Komar, by certified 
mail on June 11, 2020, a notice proposing to debar him for a 5-year 
period 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. Komar's felony conviction for one felony count 
under Federal law for mail fraud was for conduct relating to the 
importation into the United States of any drug or controlled substance 
because he illegally caused bicalutamide and isotretinoin to be 
introduced in interstate commerce from Mumbai, India, by selling to a 
consumer who did not have a prescription through the U.S. mail in 
violation of 18 U.S.C. 1341.
    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. Komar's offenses and concluded that this felony 
offense warranted the imposition of a 5-year period of debarment. The 
proposal informed Mr. Komar of the proposed debarment and offered Mr. 
Komar 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. Komar received the proposal and notice of opportunity for a 
hearing on June 22, 2020. Mr. Komar 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. Keith 
Komar 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 provided by section 306(c)(2)(A)(iii) of 
the FD&C Act.
    As a result of the foregoing finding, Mr. Komar 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 or controlled substance by, 
with the assistance of, or at the direction of Mr. Komar is a 
prohibited act.
    Any application by Mr. Komar for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2020-N-1058 and sent to the Dockets Management Staff (see 
ADDRESSES). 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 https://www.regulations.gov or at the Dockets 
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday, 240-402-7500.

    Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23135 Filed 10-19-20; 8:45 am]
BILLING CODE 4164-01-P