80 FR 35653 - Anoushirvan Sarraf: Debarment Order
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 119 (June 22, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 119 (June 22, 2015)
| Page Range | 35653-35654 | |
| FR Document | 2015-15163 |
[Federal Register Volume 80, Number 119 (Monday, June 22, 2015)] [Notices] [Pages 35653-35654] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-15163] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-2101] Anoushirvan Sarraf: 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 Anoushirvan Sarraf from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Sarraf was convicted of seven felonies under Federal law for conduct relating to the regulation of a drug product. Dr. Sarraf was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Sarraf failed to request a hearing. Dr. Sarraf's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action. DATES: This order is effective June 22, 2015. ADDRESSES: Submit applications for 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 (ELEM-4144) Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Drive, Rockville, MD 20857, 301-796-4640. [[Page 35654]] 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 July 23, 2014, the U.S. District Court for the Eastern District of Virginia entered judgment against Dr. Sarraf after a jury found him guilty of one count of conspiracy, in violation of 18 U.S.C. 371, three counts of importation contrary to law, in violation of 18 U.S.C. 545 and 18 U.S.C. 2, two counts of receipt and delivery of misbranded drugs, in violation of 21 U.S.C. 331(c), 333(a)(2), and 18 U.S.C. 2, and one count of unlicensed wholesale distribution of prescription drugs, in violation of 21 U.S.C. 331(t), 333(b)(1)(D), 353(e)(2)(A), 353(e)(3)(B), and 18 U.S.C. 2. FDA's finding that debarment is appropriate is based on the felony convictions referenced herein. The factual basis for these convictions is as follows: Dr. Sarraf was a physician and owner of Aphrodite in McLean, Virginia, in the Eastern District of Virginia. Dr. Sarraf provided his medical license to Gallant Pharma International Inc. (Gallant Pharma), for use by international co-conspirators, received importations in his and Aphrodite's name on behalf of Gallant Pharma, and purchased misbranded and non-FDA approved drugs and devices from Gallant Pharma. In exchange for use of his medical license, mailing name, and address, Dr. Sarraf received discounted pricing from Gallant Pharma. Beginning in or around June 2009, and continuing until at least August 2013, in the Eastern District of Virginia and elsewhere, Dr. Sarraf knowingly and intentionally conspired and agreed to commit offenses against the United States by: Fraudulently and knowingly importing misbranded drugs; knowingly engaging in the wholesale distribution of prescription drugs in Virginia without being licensed to do so; receiving in interstate commerce, delivering and proffering delivery for pay, misbranded drugs; defrauding the United States and its Agencies by impeding, impairing, and defeating the lawful functions of FDA to protect the health and safety of the public. Dr. Sarraf provided Gallant Pharma with his medical license to enable Gallant Pharma to order non-FDA-approved chemotherapy and cosmetic drugs from around the world, and allowed those drugs to be shipped into the United States to Aphrodite. When the drugs arrived, he would alert individuals at Gallant Pharma to retrieve the illegal drugs. He additionally would take some of the misbranded and non-FDA- approved drugs from the packages intended for Gallant Pharma for use on his patients at Aphrodite. Between August 2009 and August 2012, Dr. Sarraf received and handed off at least 40 shipments containing illegally imported drugs and devices. Between August 2009 and August 2012, Dr. Sarraf purchased approximately $250,000 in misbranded and non-FDA-approved drugs and devices from Gallant Pharma. As a result of his convictions, on March 9, 2015, FDA sent Dr. Sarraf 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 the finding, under section 306(a)(2)(B) of the FD&C Act, that Dr. Sarraf was convicted of felonies under Federal law for conduct related to the regulation of a drug product. FDA determined that Dr. Sarraf's felony convictions were related to the regulation of drug products because the conduct underlying his convictions undermined FDA's regulatory oversight over drug products marketed in the United States, by intentionally introducing into interstate commerce drug misbranded products. The proposal also offered Dr. Sarraf an opportunity to request a hearing, provided 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 March 12, 2015. Dr. Sarraf 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 and Import Operations, 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 Anoushirvan Sarraf has been convicted of seven felonies under Federal law for conduct relating to the regulation of a drug product. As a result of the foregoing findings, Anoushirvan Sarraf 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 section 201(dd), 306(c)(1)(B), and 306(c)(2)(A)(ii) of the FD&C Act, (21 U.S.C. 321(dd), 335a(c)(1)(B), and 335a(c)(2)(A)(ii)). 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 Anoushirvan Sarraf, in any capacity during his 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. Sarraf 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 (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 Anoushirvan Sarraf during his period of debarment (section 306(c)(1)(A) of the FD&C Act (21 U.S.C. 335a(c)(1)(A))). Any application by Dr. Sarraf for special termination of debarment under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) should be identified with Docket No. FDA-2014-N-2101 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. Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 16, 2015. Douglass Stearn, Director, Division of Compliance Policy, Office of Enforcement, Office of Regulatory Affairs. [FR Doc. 2015-15163 Filed 6-19-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 119 / Monday, June 22, 2015 / Notices 35653
factual basis for this conviction is as by non-FDA approved packaging and section 306(d)(4) of the FD&C Act (21
follows: Between around August 2009 inserts. The proposal also offered Mr. U.S.C. 335a(d)(4)) should be identified
and August 2013, Mr. Aminzada owned Aminzada an opportunity to request a with Docket No. FDA–2015–N–0097
and operated several companies hearing, providing him 30 days from the and sent to the Division of Dockets
dedicated to international sales, date of receipt of the letter in which to Management (see ADDRESSES). All such
including Royal Canadian Imports file the request, and advised him that submissions are to be filed in four
(headquartered in Canada), and Essa failure to request a hearing constituted copies. The public availability of
Gulf Trading (headquartered in Dubai, a waiver of the opportunity for a hearing information in these submissions is
United Arab Emirates). and of any contentions concerning this governed by 21 CFR 10.20.
Between approximately August 2009 action. The proposal was received on Publicly available submissions may
and August 2012, Mr. Aminzada sold March 16, 2015. Mr. Aminzada failed to be seen in the Division of Dockets
misbranded chemotherapy drugs and respond within the timeframe Management between 9 a.m. and 4 p.m.,
injectable cosmetic drugs to Gallant prescribed by regulation and has, Monday through Friday.
Pharma International, Inc. (Gallant therefore, waived his opportunity for a Dated: June 16, 2015.
Pharma) for resale in the United States. hearing and has waived any contentions
Douglass Stearn,
Neither of Mr. Aminzada’s companies concerning his debarment (21 CFR part
were licensed as a prescription drug Director, Division of Compliance Policy,
12).
Office of Enforcement, Office of Regulatory
wholesaler anywhere in the United
II. Findings and Order Affairs.
States. Mr. Aminzada admitted that the
Therefore, the Director, Office of [FR Doc. 2015–15162 Filed 6–19–15; 8:45 am]
drugs he sold to Gallant Pharma for
resale in the United States were Enforcement and Import Operations, BILLING CODE 4164–01–P
prescription only, and that many of the Office of Regulatory Affairs, under
drugs were misbranded in that the drugs section 306(a)(2)(B) of the FD&C Act,
did not bear adequate directions for use under authority delegated to the DEPARTMENT OF HEALTH AND
and were not subject to an exemption Director (Staff Manual Guide 1410.35), HUMAN SERVICES
from that requirement, and were finds that Mirwaiss Aminzada has been
Food and Drug Administration
accompanied by non-FDA approved convicted of a felony under Federal law
packaging and inserts, which were for conduct relating to the regulation of [Docket No. FDA–2014–N–2101]
sometimes written in foreign languages. a drug product. Section 306(c)(2)(A)(ii)
The drugs Mr. Aminzada sold to Gallant of the FD&C Act (21 U.S.C. Anoushirvan Sarraf: Debarment Order
Pharma also lacked the FDA-required 335a(c)(2)(A)(ii)) requires that Mr. AGENCY: Food and Drug Administration,
pedigree, which protects patients’ Aminzada’s debarment be permanent. HHS.
health by tracking each sale, purchase, As a result of the foregoing findings,
ACTION: Notice.
or trade of a drug from the time of Mirwaiss Aminzada is permanently
manufacturing to delivery to the patient. debarred from providing services in any SUMMARY: The Food and Drug
Between August 2009 and August 2012, capacity to a person with an approved Administration (FDA) is issuing an
Mr. Aminzada received at least or pending drug product application order under the Federal Food, Drug, and
$586,798 in wire transfers from Gallant under sections 505, 512, or 802 of the Cosmetic Act (the FD&C Act)
Pharma, representing revenues from FD&C Act (21 U.S.C. 355, 360b, or 382), permanently debarring Anoushirvan
sales of such drugs to Gallant Pharma. or under section 351 of the Public Sarraf from providing services in any
Mr. Aminzada admitted that his actions Health Service Act (42 U.S.C. 262), capacity to a person that has an
were in all respect knowing, voluntary, effective (see DATES) (see sections approved or pending drug product
intentional, and did not occur by 201(dd), 306(c)(1)(B), and application. FDA bases this order on a
accident, mistake, or for another 306(c)(2)(A)(ii) of the FD&C Act, (21 finding that Dr. Sarraf was convicted of
innocent reason. U.S.C. 321(dd), 335a(c)(1)(B), and seven felonies under Federal law for
As a result of his conviction, on 335a(c)(2)(A)(ii)). Any person with an conduct relating to the regulation of a
March 9, 2015, FDA sent Mr. Aminzada approved or pending drug product drug product. Dr. Sarraf was given
a notice by certified mail proposing to application who knowingly employs or notice of the proposed permanent
permanently debar him from providing retains as a consultant or contractor, or debarment and an opportunity to
services in any capacity to a person that otherwise uses the services of Mirwaiss request a hearing within the timeframe
has an approved or pending drug Aminzada, in any capacity during his prescribed by regulation. Dr. Sarraf
product application. The proposal was debarment, will be subject to civil failed to request a hearing. Dr. Sarraf’s
based on the finding, under section money penalties (section 307(a)(6) of the failure to request a hearing constitutes a
306(a)(2)(B) of the FD&C Act, that Mr. FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. waiver of his right to a hearing
Aminzada was convicted of a felony Aminzada provides services in any concerning this action.
under Federal law for conduct related to capacity to a person with an approved
DATES: This order is effective June 22,
the regulation of a drug product. FDA or pending drug product application
2015.
determined that Mr. Aminzada’s felony during his period of debarment he will
conviction was related to the regulation be subject to civil money penalties ADDRESSES: Submit applications for
of drug products because the conduct (section 307(a)(7) of the FD&C Act (21 termination of debarment to the
underlying his conviction undermined U.S.C. 335b(a)(7))). In addition, FDA Division of Dockets Management (HFA–
FDA’s regulatory oversight over drug will not accept or review any 305), Food and Drug Administration,
tkelley on DSK3SPTVN1PROD with NOTICES
products marketed in the United States abbreviated new drug applications 5630 Fishers Lane, Rm. 1061, Rockville,
by intentionally introducing into submitted by or with the assistance of MD 20852.
interstate commerce drug products that Mirwaiss Aminzada during his period of FOR FURTHER INFORMATION CONTACT:
did not bear adequate directions for use debarment (section 306(c)(1)(A) of the Kenny Shade (ELEM–4144) Office of
and were not subject to an exemption FD&C Act (21 U.S.C. 335a(c)(1)(A))). Regulatory Affairs, Food and Drug
from that requirement, and which, Any application by Mr. Aminzada for Administration, 12420 Parklawn Drive,
among other things, were accompanied special termination of debarment under Rockville, MD 20857, 301–796–4640.
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![35654 Federal Register / Vol. 80, No. 119 / Monday, June 22, 2015 / Notices
SUPPLEMENTARY INFORMATION: allowed those drugs to be shipped into debarred from providing services in any
the United States to Aphrodite. When capacity to a person with an approved
I. Background
the drugs arrived, he would alert or pending drug product application
Section 306(a)(2)(B) of the FD&C Act individuals at Gallant Pharma to under sections 505, 512, or 802 of the
(21 U.S.C. 335a(a)(2)(B)) requires retrieve the illegal drugs. He FD&C Act (21 U.S.C. 355, 360b, or 382),
debarment of an individual if FDA finds additionally would take some of the or under section 351 of the Public
that the individual has been convicted misbranded and non-FDA-approved Health Service Act (42 U.S.C. 262),
of a felony under Federal law for drugs from the packages intended for effective (see DATES) (see section
conduct relating to the regulation of any Gallant Pharma for use on his patients 201(dd), 306(c)(1)(B), and
drug product under the FD&C Act. at Aphrodite. 306(c)(2)(A)(ii) of the FD&C Act, (21
On July 23, 2014, the U.S. District Between August 2009 and August U.S.C. 321(dd), 335a(c)(1)(B), and
Court for the Eastern District of Virginia 2012, Dr. Sarraf received and handed off 335a(c)(2)(A)(ii)). Any person with an
entered judgment against Dr. Sarraf after at least 40 shipments containing approved or pending drug product
a jury found him guilty of one count of illegally imported drugs and devices. application who knowingly employs or
conspiracy, in violation of 18 U.S.C. Between August 2009 and August 2012, retains as a consultant or contractor, or
371, three counts of importation Dr. Sarraf purchased approximately otherwise uses the services of
contrary to law, in violation of 18 U.S.C. $250,000 in misbranded and non-FDA- Anoushirvan Sarraf, in any capacity
545 and 18 U.S.C. 2, two counts of approved drugs and devices from during his debarment, will be subject to
receipt and delivery of misbranded Gallant Pharma. civil money penalties (section 307(a)(6)
drugs, in violation of 21 U.S.C. 331(c), As a result of his convictions, on of the FD&C Act (21 U.S.C. 335b(a)(6))).
333(a)(2), and 18 U.S.C. 2, and one March 9, 2015, FDA sent Dr. Sarraf a If Dr. Sarraf provides services in any
count of unlicensed wholesale notice by certified mail proposing to capacity to a person with an approved
distribution of prescription drugs, in permanently debar him from providing or pending drug product application
violation of 21 U.S.C. 331(t), services in any capacity to a person that during his period of debarment he will
333(b)(1)(D), 353(e)(2)(A), 353(e)(3)(B), has an approved or pending drug be subject to civil money penalties
and 18 U.S.C. 2. product application. The proposal was (section 307(a)(7) of the Act (21 U.S.C.
FDA’s finding that debarment is based on the finding, under section 335b(a)(7))). In addition, FDA will not
appropriate is based on the felony 306(a)(2)(B) of the FD&C Act, that Dr. accept or review any abbreviated new
convictions referenced herein. The Sarraf was convicted of felonies under drug applications submitted by or with
factual basis for these convictions is as Federal law for conduct related to the the assistance of Anoushirvan Sarraf
follows: Dr. Sarraf was a physician and regulation of a drug product. FDA during his period of debarment (section
owner of Aphrodite in McLean, determined that Dr. Sarraf’s felony 306(c)(1)(A) of the FD&C Act (21 U.S.C.
Virginia, in the Eastern District of convictions were related to the 335a(c)(1)(A))).
Virginia. Dr. Sarraf provided his regulation of drug products because the Any application by Dr. Sarraf for
medical license to Gallant Pharma conduct underlying his convictions special termination of debarment under
International Inc. (Gallant Pharma), for undermined FDA’s regulatory oversight section 306(d)(4) of the FD&C Act (21
use by international co-conspirators, over drug products marketed in the U.S.C. 335a(d)(4)) should be identified
received importations in his and United States, by intentionally with Docket No. FDA–2014–N–2101
Aphrodite’s name on behalf of Gallant introducing into interstate commerce and sent to the Division of Dockets
Pharma, and purchased misbranded and drug misbranded products. The Management (see ADDRESSES). All such
non-FDA approved drugs and devices proposal also offered Dr. Sarraf an submissions are to be filed in four
from Gallant Pharma. In exchange for opportunity to request a hearing, copies. The public availability of
use of his medical license, mailing provided him 30 days from the date of information in these submissions is
name, and address, Dr. Sarraf received receipt of the letter in which to file the governed by 21 CFR 10.20.
discounted pricing from Gallant request, and advised him that failure to Publicly available submissions may
Pharma. request a hearing constituted a waiver of be seen in the Division of Dockets
Beginning in or around June 2009, the opportunity for a hearing and of any Management between 9 a.m. and 4 p.m.,
and continuing until at least August contentions concerning this action. The Monday through Friday.
2013, in the Eastern District of Virginia proposal was received on March 12,
and elsewhere, Dr. Sarraf knowingly Dated: June 16, 2015.
2015. Dr. Sarraf failed to respond within
and intentionally conspired and agreed Douglass Stearn,
the timeframe prescribed by regulation
to commit offenses against the United and has, therefore, waived his Director, Division of Compliance Policy,
States by: Fraudulently and knowingly Office of Enforcement, Office of Regulatory
opportunity for a hearing and has
importing misbranded drugs; knowingly Affairs.
waived any contentions concerning his
engaging in the wholesale distribution [FR Doc. 2015–15163 Filed 6–19–15; 8:45 am]
debarment (21 CFR part 12).
of prescription drugs in Virginia BILLING CODE 4164–01–P
without being licensed to do so; II. Findings and Order
receiving in interstate commerce, Therefore, the Director, Office of
delivering and proffering delivery for Enforcement and Import Operations, DEPARTMENT OF HEALTH AND
pay, misbranded drugs; defrauding the Office of Regulatory Affairs, under HUMAN SERVICES
United States and its Agencies by section 306(a)(2)(B) of the FD&C Act, Health Resources and Services
impeding, impairing, and defeating the under authority delegated to the Administration
tkelley on DSK3SPTVN1PROD with NOTICES
lawful functions of FDA to protect the Director (Staff Manual Guide 1410.35),
health and safety of the public. finds that Anoushirvan Sarraf has been Delegation of Authority
Dr. Sarraf provided Gallant Pharma convicted of seven felonies under
with his medical license to enable Federal law for conduct relating to the Notice is hereby given that I have
Gallant Pharma to order non-FDA- regulation of a drug product. delegated to the Administrator of the
approved chemotherapy and cosmetic As a result of the foregoing findings, Health Resources and Services
drugs from around the world, and Anoushirvan Sarraf is permanently Administration, or his or her successor,
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Document Created: 2018-02-22 11:14:01
Document Modified: 2018-02-22 11:14:01
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | This order is effective June 22, 2015. | |
| Contact | Kenny Shade (ELEM-4144) Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Drive, Rockville, MD 20857, 301-796-4640. | |
| FR Citation | 80 FR 35653 |
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