[Federal Register Volume 80, Number 119 (Monday, June 22, 2015)]
[Notices]
[Pages 35653-35654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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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