[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)]
[Notices]
[Pages 79501-79502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27244]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-4169]
Edward Manookian (Also Known as Ed Manning): Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The U.S. Food and Drug Administration (FDA or Agency) is
issuing an order under the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) permanently debarring Edward Manookian 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 Mr.
Manookian was convicted of felonies under Federal law for conduct
relating to the regulation of a drug product under the FD&C Act. Mr.
Manookian was given notice of the proposed permanent debarment and an
opportunity to request a hearing within the timeframe prescribed by
regulation. Mr. Manookian failed to request a hearing. Mr. Manookian's
failure to request a hearing constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is effective November 14, 2016.
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 Enforcement,
Food and Drug Administration, 12420 Parklawn Dr. (ELEM-4144),
Rockville, MD 20857, 301-796-4640.
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 August 28,
2015, the U.S. District Court for the Middle District of Tennessee
entered judgment against Mr. Manookian for two counts of conspiracy to
commit an offense against the United States, in violation of 18 U.S.C.
371.
FDA's finding that the debarment is appropriate is based on the
felony convictions referenced herein. The factual basis for these
convictions is as follows: Mr. Manookian was the President and owner of
Melanocorp, Inc. (Melanocorp), a for-profit corporation that conducted
operations in the Middle District of Tennessee, and his duties included
overseeing the employees and operations of Melanocorp.
Melanotan II (MII) was a peptide, or series of amino acids, that
was marketed, sold, and shipped by Melanocorp to customers in the
United States and abroad. Mr. Manookian's company advertised MII, an
unapproved new drug, as an injectable tanning product through an
internet Web site. The Melanocorp Web site also advertised MII as being
100 percent U.S. made, whereas in fact some of the MII sold by
Melanocorp was manufactured in and imported from China.
On or about August 30, 2007, Melanocorp received a warning letter
from FDA expressing concern about Melanocorp's marketing of MII. The
warning letter noted that, based on information and statements on the
Melanocorp Web site, MII constituted a new drug under the FD&C Act that
could not be introduced or delivered for introduction into interstate
commerce without an FDA approved application. The warning letter
concluded that the sale of MII without an FDA approved application
violated the FD&C Act and instructed Mr. Manookian's company to take
prompt action to correct the violations cited in the warning letter.
On or about September 17, 2007, after consulting with counsel, Mr.
Manookian sent a letter to FDA stating that Melanocorp had stopped all
promotion and sale of MII in the United States and had stopped taking
orders for MII from U.S. residents.
On or about November 29, 2007, FDA sent a letter to an attorney
representing Melanocorp, which reiterated that MII was considered by
FDA to be an unapproved drug and warned that its introduction or
delivery for introduction into interstate commerce would be a violation
of the FD&C Act. The letter specifically stated that the sale of MII
outside of the United States violated the FD&C Act.
On or about December 14, 2007, Mr. Manookian had a letter sent to
FDA from his attorney confirming that Melanocorp had stopped taking
orders for MII from U.S. residents. This letter also stated that
Melanocorp did not disagree that FDA considered MII to be an unapproved
new drug, but Mr. Manookian's position was that Melanocorp could
lawfully export MII, regardless of its status as an unapproved new
drug.
On or about December 28, 2007, FDA sent a letter to Mr. Manookian's
attorney which reiterated that unapproved new drugs do not qualify for
export.
Following receipt of the December 28, 2007, correspondence from
FDA, Melanocorp continued to ship MII in interstate commerce.
Melanocorp primarily sold MII to customers located abroad, but also
shipped MII domestically on a more limited basis.
From on or about September 17, 2007, and continuing through in or
about April 2009, Mr. Manookian conspired with others to defraud the
United States by causing Melanocorp to ship MII to customers in the
United States despite telling FDA that Melanocorp would not distribute
or market MII in the United States.
As a result of these convictions, FDA sent Mr. Manookian by
certified mail on
[[Page 79502]]
August 29, 2016, a notice 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 FD&C Act, that Mr. Manookian was
convicted of felonies under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. FDA determined that
Mr. Manookian'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--Mr. Manookian knowingly sold unapproved drugs and put patients
at risk. The proposal also offered Mr. Manookian 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. The proposal was
received on September 2, 2016. Mr. Manookian did not request a hearing
and has, therefore, waived his opportunity for a hearing and 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 him (Staff Manual Guide
1410.35), finds that Edward Manookian has been convicted of felonies
under Federal law for conduct relating to the regulation of a drug
product under the FD&C Act. Section 306(c)(2)(A)(ii) of the FD&C Act
requires that Mr. Manookian's debarment be permanent.
As a result of the foregoing finding, Edward Manookian is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application under
section 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 sections 201(dd) (21 U.S.C. 321(dd),
306(c)(1)(B), and (c)(2)(A)(ii) of the FD&C Act). 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 Edward Manookian, 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 Mr. Manookian 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 FD&C Act). In addition, FDA will not accept
or review any abbreviated new drug applications from Edward Manookian
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
Any application by Mr. Manookian for special termination of
debarment under section 306(d)(4) of the FD&C Act should be identified
with Docket No. FDA-2015-N-4169 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 will be placed in the docket, and
will be viewable at http://www.regulations.gov or at the Division of
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: November 7, 2016.
Armando Zamora,
Deputy Director, Office of Enforcement and Import Operations, Office of
Regulatory Affairs.
[FR Doc. 2016-27244 Filed 11-10-16; 8:45 am]
BILLING CODE 4164-01-P