FR DATE:08/05/2003

[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]                         

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

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.

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

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]

BILLING CODE 4160-01-S