[Federal Register Volume 77, Number 127 (Monday, July 2, 2012)]
[Notices]
[Pages 39245-39246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0063]


Sami Arshak Yanikian: 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) debarring 
Sami Arshak Yanikian for 10 years 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. Yanikian was 
convicted of two counts of introducing unapproved new drugs into 
interstate commerce, which relates to the development or approval, 
including the process for development or approval, of drug products and 
to the regulation of drug products under the FD&C Act. In addition, the 
type of conduct that served as the basis for Mr. Yanikian's convictions 
undermine the process for the regulation of drugs. Mr. Yanikian was 
given notice of the proposed debarment and an opportunity to request a 
hearing within the timeframe prescribed by regulation. Mr. Yanikian 
failed to respond. Mr. Yanikian's failure to respond constitutes a 
waiver of his right to a hearing concerning this action.

DATES: This order is effective July 2, 2012.

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, Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, 
MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds 
that the individual has been convicted of a misdemeanor under Federal 
law for conduct relating to the development or approval, including the 
process for development or approval, of any drug product or otherwise 
relating to the regulation of drug products under the FD&C Act, and if 
FDA finds that the type of conduct that served as the basis for the 
conviction undermines the process for the regulation of drugs.
    On June 29, 2011, Mr. Yanikian was found guilty of two counts of 
introduction of an unapproved drug in interstate commerce, in violation 
of sections 301(d), 505(a), and 303(a)(1) of the FD&C Act (21 U.S.C. 
331(d), 355(a), 333(a)(1)) and of aiding and abetting, in violation of 
18 U.S.C. 2(b), and the U.S. District Court for the Central District of 
California entered judgment against Mr. Yanikian for the misdemeanor 
offenses of introduction of an unapproved drug in interstate commerce 
and aiding and abetting.
    The FDA's finding that debarment is appropriate is based on the 
misdemeanor convictions referenced herein. The factual basis for the 
conviction is as follows: On March 17, 2005, FDA sent Mr. Yanikian a 
warning letter regarding his marketing and sale of Novel natural 
formulation for atrial fibrillation, Super Nasal Drops, and Sams No 
Tinnitus Formulation. The warning letter described the claims Mr. 
Yanikian's Web site was making pertaining to these products and 
informed him that his claims caused the products to be ``drugs'' as 
defined by the FD&C Act because they were intended to cure, mitigate, 
treat, or prevent disease. Mr. Yanikian was informed that his products 
were ``new drugs'' and that a new drug could not be introduced or 
delivered for introduction into interstate commerce unless an FDA-
approved application was in effect for it. The

[[Page 39246]]

warning letter additionally noted that none of the products described 
had an approved application and that their introduction or delivery for 
introduction into interstate commerce violated section 301(d) of the 
FD&C Act. Mr. Yanikian was advised to immediately correct the 
violations.
    In response, on April 11, 2005, Mr. Yanikian wrote a reply letter 
to FDA in which he stated that the products were mailed for sale 
outside the United States to hospitals that deal with natural health 
products. He further noted that his products were not intended for sale 
as over-the-counter or for single individuals in the United States 
until they were approved by FDA.
    Despite knowing that he was not allowed to sell these unapproved 
new drugs in the United States without FDA approval, and despite his 
repeated representations to FDA that he was not selling his products to 
customers in the United States, Mr. Yanikian subsequently sold his 
unapproved new drug products to an undercover agent in November 2005, 
and again in November 2006, in violation of sections 301(d), 505(a), 
and 303(a)(1) of the FD&C Act and 18 U.S.C. 2(b).
    As a result of his conviction, on April 3, 2012, FDA sent Mr. 
Yanikian a notice by certified mail proposing to debar him for 10 years 
from providing services in any capacity to a person that has an 
approved or pending drug product application. FDA subsequently 
confirmed that Mr. Yanikian personally received the notice on April 11, 
2012. The proposal was based on a finding, under section 
306(b)(2)(B)(i)(I) of the FD&C Act that Mr. Yanikian was convicted of 
two counts of a misdemeanor under Federal law. In the notice, FDA found 
that the conduct underlying these Federal misdemeanor convictions 
relates to the development or approval, including the process for 
development or approval, of drug products and relates to the regulation 
of drug products under the FD&C Act and undermines the process for the 
regulation of drugs because the introduction and causing the 
introduction of unapproved new drugs into interstate commerce are 
prohibited by the FD&C Act. The proposal also offered Mr. Yanikian 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. Mr. Yanikian failed to respond within the timeframe prescribed 
by regulation, and has therefore waived his opportunity for a hearing 
and waived any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act 
under authority delegated to him (Staff Manual Guide 1410.35), finds 
that Sami Arshak Yanikian has been convicted of two counts of a 
misdemeanor under Federal law for conduct relating to the development 
or approval, including the process for development or approval, of drug 
products and relating to the regulation of drug products under the FD&C 
Act, and that the type of conduct that served as a basis for the 
conviction undermines the process for the regulation of drugs.
    As a result of the foregoing finding, Mr. Yanikian is debarred for 
10 years 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 sections 306(c)(1)(B), (c)(2)(A)(iii), and 201(dd) of the 
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), and 321(dd))). 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 Mr. Yanikian, in any capacity during Mr. 
Yanikian's 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. Yanikian 
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 submitted by or with the assistance of Mr. Yanikian 
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Mr. Yanikian for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2012-N-0063 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(j).
    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 15, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-16156 Filed 6-29-12; 8:45 am]
BILLING CODE 4160-01-P