[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Pages 26784-26785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10973]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0865]


David Freeman: 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 
David Freeman for 5 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. Freeman was convicted of 
introducing and delivering for introduction into interstate commerce of 
a misbranded drug, 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, FDA 
determined that the type of conduct that served as the basis for Mr. 
Freeman's conviction undermines the process for the regulation of 
drugs. Mr. Freeman was given notice of the proposed debarment and an 
opportunity to request a hearing within the prescribed timeframe by 
regulation, but failed to respond. Mr. Freeman's failure to respond 
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is effective May 8, 2013.

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 May 5, 2010, Mr. Freeman pleaded guilty to a misdemeanor offense 
of introducing and delivering for introduction into interstate commerce 
of a misbranded drug in violation of 21 U.S.C. 352(o), 331(a), and 
333(a)(1). On July 7, 2011, the U.S. District Court for the District of 
Nevada entered judgment against Mr. Freeman for the misdemeanor offense 
of misbranding.
    The FDA's finding that debarment is appropriate is based on the 
misdemeanor conviction referenced herein. The factual basis for the 
conviction is as follows: On July 23, 2008, Agents from Customs and 
Border Protection found two express mail packages at JFK International 
Mail Facility, each with a return address of Muhi Trading Corporation, 
Bahadur Manzil. A border search was conducted on both packages, which 
revealed 1,000 capsules labeled as the prescription drug omeprazole in 
each package. The pills were in blister packs on which was written 
``Omega Biotech LTD.'' Mr. Freeman and his co-defendant, Mr. Ashley 
Brandon Foyle, were the importers of record for the packages. At all 
relevant times, neither Muhi Trading Corporation nor Omega Biotech LTD. 
were registered to manufacture, prepare, propagate, compound, or 
process drugs.
    On January 20, 2009, an Agent with the Office of Criminal 
Investigations at FDA (OCI) conducted an undercover purchase of 
omeprazole through a Web site Mr. Freeman and Mr. Foyle used to sell 
their misbranded drugs. Mr. Freeman and Mr. Foyle repackaged omeprazole 
in their apartment and mailed it to the undercover agent. Laboratory 
testing of the tablets confirmed that the tablets contained omeprazole. 
On February 24, 2009, OCI agents searched Mr. Freeman and Mr. Foyle's 
residence and found unapproved drugs. The omeprazole pills that Mr. 
Freeman and Mr. Foyle imported, repackaged and sold had not been 
approved by or registered with FDA. At no time was Mr. Freeman and Mr. 
Foyle's apartment registered as a location where drugs could be 
manufactured, prepared, propagated, compounded, or processed.
    As a result of his convictions, on October 31, 2012, FDA sent Mr. 
Freeman a notice by certified mail proposing to debar him for 5 years 
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(b)(2)(B)(i)(I) of the FD&C Act that Mr. 
Freeman was convicted 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 to the regulation of drug 
products under the FD&C Act, and the conduct that served as the basis 
for Mr. Freeman's conviction undermines the process for the regulation 
of drugs because the introduction of misbranded drugs into interstate 
commerce is prohibited by the FD&C Act. The proposal also offered Mr. 
Freeman 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. Freeman 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 and Import 
Operations, 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 David Freeman 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 drug products and relating to the regulation of drug 
products under the FD&C Act, and that the type of conduct that served 
as the basis for the conviction undermines the process for the 
regulation of drugs.
    As a result of the foregoing finding, Mr. Freeman is debarred for 5 
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. 355a(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

[[Page 26785]]

contractor, or otherwise uses the services of Mr. Freeman, in any 
capacity during Mr. Freeman's debarment, will be subject to civil money 
penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 355b(a)(b)). If 
Mr. Freeman 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. Freeman during his period of debarment (section 
306(c)(1)(B) of the FD&C Act).
    Any application by Mr. Freeman for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2012-N-0865 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: April 3, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for Regulatory Affairs, Office of 
Regulatory Affairs.
[FR Doc. 2013-10973 Filed 5-7-13; 8:45 am]
BILLING CODE 4160-01-P