Debarment Orders:
Federal Register: August 18, 2010 (Volume 75, Number 159)
Notices
Page 51079-51080
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr18au10-113
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.
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:
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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.
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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
