[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