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)

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.

[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]


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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.

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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 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]
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