[Federal Register: August 5, 2003 (Volume 68, Number 150)]
[Notices]
[Page 46197-46198]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05au03-64]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002N-0511]
Thomas Ronald Theodore; 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 act) permanently
debarring Mr. Thomas Ronald Theodore from providing services in any
capacity to a person that has an approved or pending drug product
application including, but not limited to, a biologics license
application. FDA bases this order on a finding that Mr. Theodore was
convicted of a felony under Federal law for conduct relating to the
regulation of a drug product under the act. After being given notice of
the proposed permanent debarment and his opportunity to request a
hearing within the timeframe prescribed by regulation, Mr. Theodore
failed to request a hearing. Mr. Theodore's failure to request a
hearing constitutes a waiver of his right to a hearing concerning this
action.
DATES: This order is effective August 5, 2003.
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: Kathleen Swisher, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
On March 1, 2002, the U.S. District Court for the District of
Massachusetts
[[Page 46198]]
entered judgment against Mr. Theodore for nine counts of mail fraud,
Federal felony offenses under 18 U.S.C. 1341. Mr. Theodore devised a
scheme and artifice to defraud and to obtain money and property by
means of false and fraudulent pretenses and representations. Mr.
Theodore illegally arranged to ship an unapproved new drug identified
as ``LK-200'' that had been manufactured in Woburn, MA, to the Bahamas,
and then arranged to have the drug shipped from the Bahamas to
pharmacists, physicians, and patients in the United States.
As a result of this conviction, FDA sent to Mr. Theodore by
certified mail on December 17, 2002, a notice proposing to permanently
debar Mr. Theodore from providing services in any capacity to a person
that has an approved or pending drug product application including, but
not limited to, a biologics license application. The proposal also
offered Mr. Theodore an opportunity for a hearing on the proposal. The
proposal was based on a finding, under section 306(a)(2)(B) and
(c)(2)(A)(ii) of the act (21 U.S.C. 335a(a)(2)(B) and (c)(2)(A)(ii)),
that Mr. Theodore was convicted of a felony under Federal law for
conduct relating to the regulation of a drug product. Mr. Theodore was
provided 30 days to file objections and request a hearing. On January
3, 2003, FDA received from Mr. Theodore a response to the proposal to
debar and notice of opportunity for hearing. Mr. Theodore did not
request a hearing. Mr. Theodore argued that, although he was convicted
of all felony counts, an appeal is pending. However, this argument
fails under the applicability of conviction provision of section
306(l)(1)(A) of the act (21 U.S.C. 335a(l)(1)(A)). This law states that
a person is considered to have been convicted of a criminal offense
when a judgment of conviction has been entered against the person by a
Federal or State court, regardless of whether there is an appeal
pending. Therefore, Mr. Theodore's failure to request a hearing
constitutes a waiver of his opportunity for a hearing and a waiver of
any contentions concerning his debarment. In the event that the
convictions that served as the basis for Mr. Theodore's debarment are
reversed on appeal, the order of debarment shall be withdrawn. (See
section 306(d)(3)(B)(i) of the act (21 U.S.C. 335a(d)(3)(B)(i)).)
II. Findings and Order
Therefore, the Director, Center for Biologics Evaluation and
Research, under section 306(a)(2)(B) of the act (21 U.S.C.
335a(a)(2)(B)), and under authority delegated to the Director (21 CFR
5.34(a)), finds that Mr. Theodore has been convicted of a felony under
Federal law for conduct relating to the regulation of a drug product.
As a result of the foregoing finding, Mr. Theodore is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application. A drug product means a
drug, including a biological product, subject to regulation under
sections 505, 512, or 802 of the act (21 U.S.C. 355, 360b, or 382), or
under section 351 of the Public Health Service Act (42 U.S.C. 262). Any
person with an approved or pending drug product application including,
but not limited to, a biologics license application, who knowingly
employs or retains as a consultant or contractor, or otherwise uses the
services of Mr. Theodore, in any capacity, during Mr. Theodore's
permanent debarment, will be subject to civil money penalties (section
307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Mr. Theodore, during
his permanent debarment, provides services in any capacity to a person
with an approved or pending drug product application including, but not
limited to, a biologics license application, Mr. Theodore will be
subject to civil money penalties (section 307(a)(7) of the act (21
U.S.C. 335b(a)(7))). In addition, FDA will not accept or review any
abbreviated new drug applications submitted by or with the assistance
of Mr. Theodore during Mr. Theodore's permanent debarment.
Any application by Mr. Theodore for termination of debarment under
section 306(d)(4) of the act should be identified with Docket No.
2002N-0511 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies (Sec.
10.20(a) (21 CFR 10.20(a))). The public availability of information in
these submissions is governed by Sec. 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 (Sec. 10.20(j)(1)).
Dated: July 23, 2003.
Mark Elengold,
Deputy Director for Operations, Center for Biologics Evaluation and
Research.
[FR Doc. 03-19806 Filed 8-4-03; 8:45 am]
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