[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, [email protected], 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