[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Notices]
[Pages 61712-61713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25680]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0165]
Deborah Martinez Seldon: 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 (the FD&C Act)
permanently debarring Deborah Martinez Seldon 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 Ms. Seldon
was convicted of multiple felonies under Federal law for conduct
relating to the regulation of a drug product under the FD&C Act. Ms.
Seldon was given notice of the proposed permanent debarment and an
opportunity to request a hearing within the timeframe prescribed by
regulation. Ms. Seldon failed to respond. Ms. Seldon's failure to
respond constitutes a waiver of her right to a hearing concerning this
action.
DATES: This order is effective October 5, 2011.
ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Compliance
Policy (HFC-230), Office of Regulatory Affairs, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-4640.
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 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 March 27, 2009, judgment was entered against Ms. Seldon in the
United States District Court for the District of Nevada for mail fraud,
in violation of 18 U.S.C. 1341, aiding and abetting, in violation of 18
U.S.C. 2, and misbranding a drug while held for sale, in violation of
21 U.S.C. 331(k) and 333(a)(2).
The FDA's finding that debarment is appropriate is based on the
felony convictions referenced herein for conduct relating to the
regulation of a drug product. The factual basis for those convictions
is as follows: Ms. Seldon was the manager of her husband's medical
practice called A New You Medical Aesthetics (A New You) in Las Vegas,
Nevada. As the office manager of A New You, Ms. Seldon was responsible
for ordering supplies, paying bills, managing personnel, and managing
the bank accounts.
From, on or about, October 15, 2003, until on or about September
16, 2005, in the State and Federal District of Nevada, Ms. Seldon and
her husband, aided and abetted by each other, devised a scheme and
artifice to fraudulently obtain money from patients by substituting the
cheaper, non-FDA approved product marketed by Toxin Research
International that purported to be Botulinum Neurotoxin Type A (TRI-
toxin) in treatments provided to patients at A New You, while falsely
and fraudulently representing to the patients that they were receiving
injections of the FDA-approved BOTOX product marketed by Allergan,
Inc..
As part of the scheme Ms. Seldon ordered and caused to be ordered
38 vials of TRI-toxin between October 2003 and September 2004 while at
the same time the practice stopped purchasing the approved BOTOX in
October 2003. In January 2005, as part of the scheme and artifice, Ms.
Seldon arranged for a secret purchase of, and received 132 vials of
TRI-toxin for use at A New You.
Ms. Seldon and her husband defrauded patients by misleading them to
believe that they were receiving the FDA-approved drug BOTOX, when, in
fact, the patients were receiving TRI-toxin, which was not approved,
thereby exposing patients to severe health risk. On or about January
12, 2005, Ms. Seldon caused to be falsified computerized medical
records by deleting references to BOTOX and changing these entries to
the generic notation ``Cosmetic Procedure.'' In furtherance of their
scheme, Ms. Seldon and Dr. Seldon caused 28 vials of TRI-toxin to be
returned to the FDA, seeking to create the misleading impression that
they were returning 28 of the original 38 vials they had purchased. In
fact, all of the original TRI-toxin had been used on patients at A New
You, and Ms. Seldon was returning vials that were part of the secret
132 vial purchase.
Ms. Seldon and her husband also caused advertisements to be placed
in local magazines offering BOTOX, creating the false impression that
the office was using approved BOTOX when, in fact, patients were being
injected with unapproved TRI-toxin. Ms. Seldon also caused patients to
sign consent forms that fraudulently represented that Dr. Seldon would
be injecting approved BOTOX when she knew her husband was injecting
them with TRI-toxin.
As a result of her convictions, on May 23, 2011, FDA sent Ms.
Seldon a notice by certified mail 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 (21 U.S.C.
335a(a)(2)(B)), that Ms. Seldon was convicted of felonies under Federal
law for conduct relating to the regulation of a drug product under the
FD&C Act. The proposal also offered Ms. Seldon 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
[[Page 61713]]
request a hearing constituted a waiver of the opportunity for a hearing
and of any contentions concerning this action. Ms. Seldon received the
proposal on May 27, 2011, and failed to respond within the timeframe
prescribed by regulation. She therefore has waived her opportunity for
a hearing and any contentions concerning her debarment (21 CFR part
12).
II. Findings and Order
Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(a)(2)(B) of the FD&C Act (21
U.S.C. 335a(a)(2)(B)), under authority delegated to him (Staff Manual
Guide 1410.35), finds that Deborah Martinez Seldon has been convicted
of a felony under Federal law for conduct relating to the regulation of
a drug product under the FD&C Act.
As a result of the foregoing finding, Ms. Seldon is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application under sections 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), effective (see
DATES), (see section 306(c)(1)(B), (c)(2)(A)(ii), and 201(dd) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii), and 321(dd))). 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 Ms. Seldon in any capacity during Ms.
Seldon's 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 Ms. Seldon
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) (21 U.S.C. 335b(a)(7)). In addition, FDA will not accept or review
any abbreviated new drug applications submitted by or with the
assistance of Deborah Martinez Seldon during her period of debarment
(section 306(c)(1)(A) of the FD&C Act (21 U.S.C. 335a(c)(1)(A)).
Any application by Deborah Martinez Seldon for special termination
of debarment under section 306(d)(4) of the FD&C Act (21 U.S.C.
335a(d)(4)) should be identified with Docket No. FDA-2011-N-0165 and
sent to the Division of Dockets Management (see ADDRESSES). All such
submissions are to be filed in four copies. The public availability of
information in these submissions is governed by 21 CFR 10.20(j).
Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: September 6, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-25680 Filed 10-4-11; 8:45 am]
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