[Federal Register Volume 75, Number 159 (Wednesday, August 18, 2010)]
[Notices]
[Pages 51079-51080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20418]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0139]
Seth M. Yoser: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) (the Agency) is issuing
an order under the Federal Food, Drug, and Cosmetic Act (the act)
permanently debarring Seth M. Yoser, 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. Yoser was
convicted of a felony under Federal law for conduct relating to the
regulation of a drug product under the act. Dr. Yoser was given notice
of the proposed permanent debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation. In a May 20,
2010, letter to FDA, Dr. Yoser, through counsel, notified FDA that he
acquiesces to debarment and therefore he has waived his right to a
hearing concerning this action.
DATES: This order is effective May 20, 2010.
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 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 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 act.
On February 23, 2010, the U.S. District Court for the Western
District of Tennessee entered judgment against Dr. Yoser for ten counts
of mail fraud in violation of 21 U.S.C. 1341, twenty-three counts of
unlicensed wholesale distribution of prescription drugs in violation of
21 U.S.C. 331(t), 333(b)(1)(D), and 353(e)(2)(A); and two counts of
wire fraud in violation of 18 U.S.C. 1343.
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. Yoser was employed by the Eye Specialty Group (ESG), formerly known
as the Vitreorentinal Foundation, and he was a partner of ESG from on
or about June 2005, until approximately May 12, 2008. During the course
of his employment and partnership with ESG, he performed treatments
which included administering the prescription drugs Visudyne, Lucentis,
and Avastin to treat Wet Aged Macular Degeneration.
Beginning on or about July 1, 2002, and continuing up to and
including May 12, 2008, Dr. Yoser did knowingly devise a scheme and
artifice to defraud ESG and Medicare in order to obtain money and
property by means of false and fraudulent representation, billing, and
pretense. As part of that scheme, he billed Medicare for Visudyne,
Avastin, and Lucentis that he purportedly used to treat ESG patients
but that he actually diverted from ESG patients and sold.
Beginning on or about April 14, 2004, through on or about October
2, 2007, in the Western District of Tennessee, and elsewhere, Dr. Yoser
did knowingly engage in or cause the wholesale distribution in
interstate commerce of the prescription drugs, Visudyne and Lucentis in
Louisiana, Tennessee, Texas, and Arkansas without being licensed by
those states in violation of 21 U.S.C. 331(t), 333(b)(1)(D), and
353(e)(2)(A).
As a result of his convictions, on April 19, 2010, FDA sent Dr.
Yoser 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 act, that Dr. Yoser was
convicted of felonies under Federal law for conduct relating to the
regulation of a drug product under the act. The proposal also offered
Dr. Yoser 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. Yoser's attorney filed a May 20, 2010, response in which he
stated that Dr. Yoser did not object to debarment and further clarified
in writing that the May 20, 2010, letter intended to express Dr.
Yoser's acquiescence to debarment. By acquiescing to debarment, as
provided for in section 306(c)(2)(B) of the act, Dr. Yoser waived his
opportunity for a hearing and any contentions concerning his debarment.
II. Findings and Order
Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(a)(2)(B) of the act, under
authority delegated to the Acting Director (Staff Manual Guide
1410.35), finds that Seth M. Yoser has been convicted of a felony under
Federal law for conduct relating to the regulation of a drug product
under the act.
As a result of the foregoing finding and based on his notification
of acquiescence, Dr. Yoser 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 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 May 20, 2010, the date of the
notification of acquiesce (see DATES) (see sections 306(c)(1)(B),
(c)(2)(A)(ii), (c)(2)(B), and 201(dd) of the act (21 U.S.C.
335a(c)(1)(B), (c)(2)(A)(ii), (c)(2)(B), 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 Dr. Yoser, in any capacity during Dr. Yoser's debarment,
will be subject to civil money penalties (section 307(a)(6) of the act
(21 U.S.C. 335b(a)(6))). If Dr. Yoser 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 act). In addition, FDA will not accept or
review any abbreviated new drug applications submitted by or with the
assistance of Dr. Yoser during his period of debarment (section
306(c)(1)(B) of the act).
Any application by Dr. Yoser for special termination of debarment
under section 306(d)(4) of the act should be
[[Page 51080]]
identified with Docket No. FDA-2010-N-0139 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: August 10, 2010.
Howard R. Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2010-20418 Filed 8-17-10; 8:45 am]
BILLING CODE 4160-01-S