[Federal Register Volume 85, Number 53 (Wednesday, March 18, 2020)]
[Notices]
[Pages 15481-15482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05582]



[[Page 15481]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4046]


Charles Jeffrey Edwards: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
permanently debarring Charles Jeffrey Edwards from providing services 
in any capacity to a person that has an approved or pending drug 
product application. FDA bases this order on a finding that Mr. Edwards 
was convicted, as defined in the FD&C Act, of two felony counts under 
federal law for conduct that relates to the regulation of a drug 
product under the FD&C Act. Mr. Edwards was given notice of the 
proposed permanent debarment and was given an opportunity to request a 
hearing within the timeframe prescribed by regulation to show why he 
should not be debarred. As of November 15, 2019 (30 days after receipt 
of the notice), Mr. Edwards had not responded. Mr. Edwards's failure to 
respond and request a hearing constitutes a waiver of his right to a 
hearing concerning this action.

DATES: This order is applicable March 18, 2020.

ADDRESSES: Submit applications for special termination of debarment to 
the Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa (ELEM-4029) 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(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) 
requires debarment of an individual from providing services in any 
capacity to a person that has an approved or pending drug product 
application if FDA finds that the individual has been convicted of a 
felony under Federal law for conduct relating to the regulation of any 
drug product under the FD&C Act. On July 20, 2018, Mr. Edwards was 
convicted as defined in section 306(l)(1)(A) of the FD&C Act when 
judgment was entered against Mr. Edwards in the U.S. District Court for 
the Middle District of Tennessee, Nashville Division, after his plea of 
guilty, to one count of mail fraud in violation of 18 U.S.C. 1341 and 
one count of money laundering in violation of 18 U.S.C. 1957.
    The factual basis for these convictions is as follows: as contained 
in Counts 2 and 27 of the Indictment, filed on January 17, 2013, to 
which Mr. Edwards pleaded guilty, from December 2006 through August 
2009, Mr. Edwards, along with others, through Cumberland Distribution, 
Inc. (Cumberland), a company Mr. Edwards co-owned, was engaged in 
wholesale distribution of prescription drugs as defined by section 
505(e) of the FD&C Act (21 U.S.C. 355(e)). Cumberland purchased 
millions of dollars of prescription drugs from unlicensed drug 
suppliers who were not authorized to distribute drugs under section 503 
of the FD&C Act (21 U.S.C. 353). Mr. Edwards knew that these unlicensed 
suppliers often procured drugs from street level drug diverters who had 
obtained the drugs from persons with legitimate prescriptions. On many 
occasions, Mr. Edwards had drugs shipped to his shell companies, which 
Mr. Edwards used as passthroughs to create the appearance that his 
company was purchasing drugs from licensed suppliers, when in fact Mr. 
Edwards was purchasing drugs from unlicensed suppliers. Afterwards, Mr. 
Edwards had these drugs shipped to Cumberland's Nashville warehouse 
where they were repackaged and shipped to independent pharmacies around 
the country. Mr. Edwards also directed Cumberland employees to create 
false pedigree documents to make it appear that the diverted drugs were 
purchased from authorized sellers. The diverted drugs included drugs 
used to combat human immunodeficiency virus/acquired immunodeficiency 
syndrome; antipsychotic medications; antidepressants; blood pressure 
medications; diabetes medications, among others. Through the course of 
this scheme, Mr. Edwards' company had gross proceeds of approximately 
$58,984,912. Mr. Edwards and two others obtained profits of 
approximately $14,689,782.
    As a result of these convictions, FDA sent Mr. Edwards by certified 
mail on October 9, 2019, a notice proposing to permanently debar him 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
a finding, under section 306(a)(2)(B) of the FD&C Act, that Mr. Edwards 
was convicted of two felonies under Federal law for conduct relating to 
the regulation of a drug product under the FD&C Act. The proposal also 
offered Mr. Edwards 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 
an election not to use the opportunity for a hearing and a waiver of 
any contentions concerning this action. Mr. Edwards received the 
proposal on October 16, 2019. Mr. Edwards did not request a hearing 
within the timeframe prescribed by regulation and has, therefore, 
waived his opportunity for a hearing and 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(a)(2)(B) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Mr. 
Edwards has been convicted of two felonies under Federal law for 
conduct otherwise relating to the regulation of a drug product under 
the FD&C Act.
    As a result of the foregoing finding, Mr. Edwards is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application, effective (see DATES) 
(see sections 306(a)(2)(B) and 306(c)(2)(A)(ii) of the FD&C Act). Any 
person with an approved or pending drug product application who 
knowingly employs or retains as a consultant or contractor, or 
otherwise uses the services of Mr. Edwards, in any capacity during his 
debarment, will be subject to civil money penalties (section 307(a)(6) 
of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Edwards provides 
services in any capacity to a person with an approved or pending drug 
product application during his period of debarment he will be subject 
to civil money penalties (section 307(a)(7) of the FD&C Act). In 
addition, FDA will not accept or review any abbreviated new drug 
applications from Mr. Edwards during his period of debarment, other 
than in connection with an audit under section 306 of the FD&C Act 
(section 306(c)(1)(B) of the FD&C Act). Note that, for purposes of 
section 306 of the FD&C Act, a ``drug product'' is defined as a ``drug 
subject to regulation under section 505, 512, or 802 of this Act [(21 
U.S.C. 355, 360b, 382)] or under section 351 of the Public Health 
Service Act [(42 U.S.C. 262)]''

[[Page 15482]]

(section 201(dd) of the FD&C Act (21 U.S.C. 321(dd)).
    Any application by Mr. Edwards for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2019-N-4046 and sent to the Dockets Management Staff 
(see ADDRESSES). All such submissions are to be filed in four copies 
(21 CFR 10.20(a)). The public availability of information in these 
submissions is governed by 21 CFR 10.20.
    Publicly available submissions may be seen in the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05582 Filed 3-17-20; 8:45 am]
 BILLING CODE 4164-01-P