
[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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


