[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15791-15792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05717]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4054]


Brenda Elise 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 (FD&C Act) 
permanently debarring Brenda Elise 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 Mrs. Edwards was 
convicted of a felony under Federal law for conduct that relates to the 
regulation of a drug product under the FD&C Act. Mrs. Edwards was given 
notice of the proposed permanent debarment and was given an opportunity 
to request a hearing to show why she should not be debarred. As of 
January 2, 2020 (30 days after receipt of the notice), Mrs. Edwards had 
not responded. Mrs. Edwards's failure to respond and request a hearing 
constitutes a waiver of her right to a hearing concerning this action.

DATES: This order is applicable March 19, 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, Division of 
Enforcement, Office of Strategic Planning and Operational Policy, 
Office of Regulatory Affairs, Food and Drug Administration, 12420 
Parklawn Dr., Rockville, MD 20857, debarments@fda.hhs.gov, 240-402-
8743.

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

[[Page 15792]]

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 January 28, 2019, 
Mrs. Edwards was convicted as defined in section 306(l)(1)(A) of the 
FD&C Act when judgment was entered against her in the U.S. District 
Court for the Middle District of Tennessee, Nashville Division, after 
her plea of guilty, to one count of conspiracy to commit mail fraud in 
violation of 18 U.S.C. 371.
    The factual basis for this conviction is as follows: As contained 
in count 1 of the indictment, filed on January 17, 2013, to which Mrs. 
Edwards pleaded guilty, from December 2006 through August 2009, Mrs. 
Edwards, along with others, through Cumberland Distribution, Inc. 
(Cumberland), a company Mrs. Edwards was an employee of, 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). Mrs. 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, Mrs. Edwards, along with others, had 
drugs shipped to shell companies, which Cumberland used as pass-
throughs to create the appearance that Cumberland was purchasing drugs 
from licensed suppliers when in fact Cumberland was purchasing drugs 
from unlicensed suppliers. Afterwards, Mrs. Edwards, along with others, 
had these drugs shipped to Cumberland's Nashville warehouse where they 
were re-packaged and shipped to independent pharmacies around the 
country.
    Mrs. Edwards also directed Cumberland employees to take steps to 
make it appear that the diverted drugs were purchased from authorized 
sellers, such as by: (1) Cleaning pharmaceutical bottles to remove 
evidence of glue, dirt or hair; (2) inspecting bottles for signs of 
diversion, such as scratches in the label, glue residue, broken seal, 
expired product, or illegible lot numbers; and (3) attaching patient 
information pamphlets to bottles that did not have them. The diverted 
drugs included drugs used to combat human immunodeficiency virus (HIV)/
acquired immunodeficiency syndrome (AIDS), antipsychotic medications, 
anti-depressants, blood pressure medications, and diabetes medications, 
among others. Through the course of this scheme, Cumberland had gross 
proceeds of approximately $58,984,912. Mrs. Edwards and two others 
obtained profits of approximately $14,689,782.
    As a result of this conviction, FDA sent Mrs. Edwards by certified 
mail on November 18, 2019, a notice proposing to permanently debar her 
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 Mrs. 
Edwards was convicted of a felony under Federal law for conduct 
relating to the regulation of a drug product under the FD&C Act. The 
proposal also offered Mrs. Edwards an opportunity to request a hearing, 
providing her 30 days from the date of receipt of the letter in which 
to file the request, and advised her that failure to file a timely 
request for a hearing constituted an election not to use the 
opportunity for a hearing and a waiver of any contentions concerning 
this action. Mrs. Edwards received the proposal on December 2, 2019. 
Mrs. Edwards did not request a hearing within the timeframe prescribed 
by regulation and has, therefore, waived her opportunity for a hearing 
and any contentions concerning her 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 Brenda 
Elise Edwards has been convicted of a felony 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, Brenda Elise Edwards is 
permanently debarred from providing services in any capacity to a 
person with an approved or pending drug product application, applicable 
(see DATES) (see section 306(a)(2)(B) and (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 Brenda Elise Edwards, in any capacity 
during her 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 Mrs. Edwards 
provides services in any capacity to a person with an approved or 
pending drug product application during her period of debarment, she 
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 Mrs. Edwards during her period of debarment, 
other than in connection with an audit under 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 the FD&C Act (21 U.S.C. 355, 360b, or 382) 
or under section 351 of the Public Health Service Act (42 U.S.C. 262) 
(see section 201(dd) of the FD&C Act (21 U.S.C. 321(dd)).
    Any application by Mrs. 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-4054 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 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05717 Filed 3-18-20; 8:45 am]
 BILLING CODE 4164-01-P


