[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11789-11790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4778]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0478]
Albert Poet: 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 Albert Poet, MD 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. Poet was
convicted of felonies under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. Dr. Poet was given
notice of the proposed permanent debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation. Dr.
Poet failed to respond. Dr. Poet's failure to respond constitutes a
waiver of his right to a hearing concerning this action.
DATES: This order is effective March 3, 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 Enforcement, Office of Regulatory
[[Page 11790]]
Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 240-632-6844.
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 otherwise
relating to the regulation of any drug product under the FD&C Act.
On September 28, 2007, the U.S. District Court District of New
Jersey entered judgment against Dr. Poet for 13 counts of mail fraud in
violation of 18 U.S.C. 2 and 1341 and 1 count of causing a drug to be
misbranded while it was held for sale after shipment in interstate
commerce with the intent to defraud or mislead in violation of 21
U.S.C. 331(k), 333(a)(2), and 352(i)(3).
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:
During 2003-2004, Dr. Poet was a physician licensed to practice
medicine in the State of New Jersey. Dr. Poet owned and operated the
Shore Laser Center and PEAU, both located in New Jersey. As part of his
practice, Dr. Poet injected patients with BOTOX, a Botulinum Toxin Type
A drug.
From on or about December 4, 2003, through in or about December
2004, Dr. Poet knowingly and willfully devised a scheme and artifice to
defraud and to obtain money and property by means of false and
fraudulent pretenses, representations, and promises. He maintained a
Web site and placed regular advertisements in local newspapers offering
BOTOX treatments at his office. Between December 4, 2003, and November
8, 2004, Dr. Poet placed 13 orders for a total of 26 vials of TRI-
Toxin, a Botulinum Toxin Type A drug manufactured by Toxin Research
International, Inc. TRI-Toxin was labeled ``For Research Purposes Only,
Not for Human Use.'' Dr. Poet injected many of the approximately 130
patients who sought BOTOX treatments with unapproved TRI-Toxin between
January 1, 2004, and December 1, 2004. As part of his scheme to
defraud, Dr. Poet did not inform most of his patients receiving the
TRI-Toxin injections that they were receiving injections of a product
not approved by FDA. Dr. Poet charged patients the same price for the
cheaper, unapproved TRI-Toxin and the approved BOTOX. For purposes of
executing the scheme and artifice, Dr. Poet knowingly and willfully
caused the TRI-Toxin to be delivered by private and commercial
interstate carrier.
As a result of his convictions, on December 13, 2010, FDA sent Dr.
Poet 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. Poet 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. Poet
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. Dr. Poet failed to respond within the timeframe prescribed by
regulation and has, therefore, waived his opportunity for a hearing and
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 Albert Poet 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. Poet 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) (see DATES) (see
sections 306(c)(1)(B) and (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. Poet, in any capacity
during Dr. Poet'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. Poet
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). In addition, FDA will not accept or review any abbreviated new
drug applications submitted by or with the assistance of Dr. Poet
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
Any application by Dr. Poet for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2010-N-0478 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: February 16, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-4778 Filed 3-2-11; 8:45 am]
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