[Federal Register Volume 76, Number 103 (Friday, May 27, 2011)]
[Notices]
[Pages 30947-30948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13198]
[[Page 30947]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0629]
Stephen Lee 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 Stephen Lee Seldon, M.D. from providing services
in any capacity to a person that has an approved or pending drug
product application. We base this order on a finding that Dr. Seldon
was convicted of felonies under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. Dr. Seldon was given
notice of the proposed permanent debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation. Dr.
Seldon failed to respond. Dr. Seldon's failure to respond constitutes a
waiver of his right to a hearing concerning this action.
DATES: This order is effective May 27, 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, Office of Regulatory
Affairs (HFC-230), 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, the U.S. District Court for the District of
Nevada entered judgment against Dr. Seldon for mail fraud in violation
of 18 U.S.C. 1341, aiding and abetting, in violation of 18 U.S.C. 2,
and misbranded a drug while held for sale in violation of 21 U.S.C.
331(k) and 333(a)(2).
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:
Dr. Seldon was a physician licensed by the State of Nevada to practice
medicine. He owned and operated a practice called A New You Medical
Aesthetics (A New You) in Las Vegas, Nevada. From on or about October
15, 2003, until on or about September 16, 2005, in the State and
Federal District of Nevada, and elsewhere Dr. Seldon and his wife,
aided and abetted by each other, devised a scheme and artifice to
fraudulently obtain money from patients by substituting cheaper, non-
FDA approved product marketed by Toxin Research International, Inc.
(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 more expensive, FDA-approved BOTOX product
manufactured by Allergan, Inc.
As part of the scheme, Dr. Seldon ordered and caused to be ordered
38 vials of TRI-toxin between October 2003 and September 2004 while at
the same time his practice stopped purchasing the approved BOTOX.
As part of his scheme, Dr. Seldon spoke at a seminar in Scottsdale,
Arizona, in September 2004, sponsored by Toxin Research International,
Inc. and claimed that he used it on patients in his practice,
notwithstanding a warning on each vial that TRI-toxin was for research
purposes only and not for human use.
Dr. Seldon defrauded his 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 FDA-approved, thereby
exposing the patients to severe health risk. Dr. Seldon also caused
advertisements to be placed in local magazines offering BOTOX
injections, creating the false impression that he was using the FDA-
approved BOTOX. Dr. Seldon additionally caused patients to sign consent
forms that fraudulently represented that he would be injecting approved
BOTOX when he knew he would be injecting the patients with TRI-toxin.
As a result of his convictions, on February 22, 2011, FDA sent Dr.
Seldon a notice by certified mail 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 Dr. 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 Dr. Seldon 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
a waiver of the opportunity for a hearing and of any contentions
concerning this action. The proposal was received on February 25, 2011.
Dr. Seldon failed to respond within the timeframe prescribed by
regulation and has, therefore, waived his opportunity for a hearing and
has waived any contentions concerning his 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, under
authority delegated to the Director (Staff Manual Guide 1410.35), finds
that Stephen Lee 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, Dr. 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 sections 306(c)(1)(B), (c)(2)(A)(ii), and 201(dd) of the
FD&C Act (21 U.S.C. 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 Dr. Seldon,
in any capacity during Dr. 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 Dr. Seldon 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 (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 Dr. Seldon during his period of
debarment (section 306(c)(1)(B) of the FD&C Act).
Any application by Dr. Seldon for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2010-N-0629 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
[[Page 30948]]
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: May 16, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-13198 Filed 5-26-11; 8:45 am]
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