Notice2022-04469
Patrick Charles Bishop: Final Debarment Order
Primary source
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Published
March 3, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Patrick Charles Bishop 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. Bishop was convicted of one felony count under Federal law for conspiracy to commit fraud. The factual basis supporting Mr. Bishop's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Bishop was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. Mr. Bishop provided notice to FDA that he acquiesced to the debarment; FDA received that notice on January 4, 2022. As such, his debarment commenced on the date FDA was notified of acquiescence.
Full Text
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<title>Federal Register, Volume 87 Issue 42 (Thursday, March 3, 2022)</title>
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[Federal Register Volume 87, Number 42 (Thursday, March 3, 2022)]
[Notices]
[Pages 12172-12174]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04469]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0873]
Patrick Charles Bishop: 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
Patrick Charles Bishop 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. Bishop was convicted of one felony count
under Federal law for conspiracy to commit fraud. The factual basis
supporting Mr. Bishop's conviction, as described below, is conduct
relating to the importation into the United States of a drug or
controlled substance. Mr. Bishop was given notice of the proposed
[[Page 12173]]
debarment and was given an opportunity to request a hearing to show why
he should not be debarred. Mr. Bishop provided notice to FDA that he
acquiesced to the debarment; FDA received that notice on January 4,
2022. As such, his debarment commenced on the date FDA was notified of
acquiescence.
DATES: This order is applicable January 4, 2022.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), 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
<a href="/cdn-cgi/l/email-protection#6105040300130c040f1512210705004f0909124f060e17"><span class="__cf_email__" data-cfemail="f5919097948798909b8186b5939194db9d9d86db929a83">[email protected]</span></a>.
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 July 9, 2021, Mr.
Bishop was convicted, as defined in section 306(l)(1) of FD&C Act, in
the U. S. District Court for the Northern District of Alabama, when the
court entered judgment against him for the offense of conspiracy to
commit fraud, in violation of 18 U.S.C. 371.
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 plea agreement in Mr. Bishop's case,
filed on January 7, 2021, in which he pleaded guilty, he owned Patrick,
LLC and employed other individuals. Using the business name ``Best
Peptide Supply, LLC,'' he ordered PNC-27 from GL Biochem (Shanghai),
Ltd., a supplier based in China, and used the PNC-27 to manufacture
drug products intended for the treatment of cancer in humans. FDA has
not approved PNC-27 for use in the United States as a drug to treat any
disease, including any form of cancer. He obtained PNC-27 under the
false pretense that he intended to use the product solely for
laboratory research purposes. In fact, he provided invoices to GL
Biochem that did not use the term ``PNC-27'' and included the statement
``FOR RESEARCH ONLY.'' He falsely certified to GL Biochem that the
product he was purchasing from GL Biochem was ``restricted to
laboratory research purposes, excluding clinical research on [the]
human body.''
Mr. Bishop also falsely represented to FDA personnel that the
product shipped from GL Biochem was to be used for laboratory testing
and scientific research. Mr. Bishop directed GL Biochem to ship the
PNC-27 to his residences and other locations in the State of Alabama
where he used the PNC-27 he purchased to manufacture drug products
intended for human use to treat cancer. Specifically, along with
others, Mr. Bishop knowingly caused PNC-27 to be processed into a
``water-based PNC-27 drug product'' as well as suppositories using
methods, controls, and facilities that did not conform to current good
manufacturing practice. Mr. Bishop sold and distributed the unapproved,
misbranded, and adulterated PNC-27 drug products he manufactured to
individuals in other States and countries; these drug products failed
to bear directions for use, and some bore no labeling whatsoever. To
avoid detection by FDA and to conceal the nature of these unapproved,
misbranded, and adulterated drug products, Mr. Bishop operated under
the business name ``Immuno Cellular Restoration Program, Inc. (ICRP)''
and used the terms, ``research,'' ``sample,'' ``ICRP'' and
``<a href="http://ICRPstudy.com">ICRPstudy.com</a>'' on his product labels and shipping documentation. Mr.
Bishop received millions of dollars in payments for his unapproved,
misbranded, and adulterated PNC-27 drug products.
As a result of this conviction, FDA sent Mr. Bishop, by certified
mail, on October 18, 2021, 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. Bishop's felony conviction for one count of
conspiracy to commit fraud was for conduct relating to the importation
into the United States of any drug or controlled substance because he
conspired to illegally import, manufacture, and distribute in
interstate commerce unapproved, misbranded, and adulterated drug
products while concealing this conduct from Federal authorities in
violation of 18 U.S.C. 371. 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. Bishop's offense and concluded
that the felony offense warranted the imposition of a 5-year period of
debarment.
The proposal informed Mr. Bishop of the proposed debarment and
offered him 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. Bishop received the proposal and notice of opportunity for
a hearing on October 25, 2021. Mr. Bishop sent a memorandum to FDA,
dated November 3, 2021, wherein he stated that he acquiesced to the
proposed debarment. FDA received the memorandum on January 4, 2022. In
accordance with section 306(c)(2)(B) of the FD&C Act, Mr. Bishop's
period of debarment shall commence on the date FDA received notice he
acquiesced to the debarment, which was January 4, 2022 (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.
Patrick Charles Bishop 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. Bishop is debarred for a
period of 5 years from importing or offering for import any drug into
the United States, effective January 4, 2022. 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. Bishop is a
prohibited act.
Any application by Mr. Bishop for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2021-N-0873 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday, 240-402-7500.
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Dated: February 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04469 Filed 3-2-22; 8:45 am]
BILLING CODE 4164-01-P
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