[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]
BILLING CODE 4160-01-P