[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4160-01-P