[Federal Register Volume 87, Number 42 (Thursday, March 3, 2022)]
[Notices]
[Pages 12172-12174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov.

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 
[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 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 
``ICRPstudy.com'' 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 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.


[[Page 12174]]


    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