FR DATE:10/20/2003

[Federal Register: October 20, 2003 (Volume 68, Number 202)]

[Notices]               
[Page 59942]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20oc03-49]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0102]

 
Robert Ray Courtney; 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 Robert Ray Courtney 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. Courtney was convicted of a 
felony under Federal law for conduct otherwise relating to the 
regulation of any drug product under the act. Mr. Courtney failed to 
request a hearing and, therefore, has waived his opportunity for a 
hearing concerning this action.

DATES: This order is effective October 20, 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: Nicole K. Mueller, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

I. Background

    On February 26, 2002, Mr. Robert Ray Courtney entered into an 
agreement pleading guilty to eight counts of tampering with consumer 
products in violation of 18 U.S.C. 1365(a) and (a)(3), and six counts 
each of misbranding and adulterating drugs in violation of sections 
301(k) and 303(a)(2) of the act (21 U.S.C. 331(k) and 333(a)(2)). On 
December 5, 2002, the U.S. District Court for the Western District of 
Missouri sentenced Mr. Courtney to the maximum 30 years in prison and 
required Mr. Courtney to pay a fine of $25,000 and $10.4 million in 
restitution for diluting drugs he dispensed to his pharmacy customers. 
Such drugs included the chemotherapy medications Gemzar (gemcitabine) 
and Taxol (paclitaxel).
    At the time of Mr. Courtney's criminal actions, he was a pharmacist 
and owner of Courtney Pharmacy, Inc., d/b/a Research Medical Tower 
Pharmacy, a company that operated two pharmacies: Research Medical 
Tower Pharmacy in Kansas City, MO, and Courtney Pharmacy in Overland 
Park, KS. Among other things, Mr. Courtney was responsible for mixing, 
preparing, labeling, and distributing intravenous drug mixtures.
    In 2001, the Federal Bureau of Investigations (FBI) and FDA set up 
an investigation that revealed that certain medications Mr. Courtney 
dispensed were far less potent than the medications ordered by 
prescribing physicians. One drug sample contained less than 1 percent 
of the prescribed amount. The investigation resulted in the filing of a 
complaint on August 14, 2001, charging Mr. Courtney with adulteration 
and misbranding. It was eventually determined that more than 4,000 
patients may have had their prescriptions diluted by Mr. Courtney over 
a 10-year period. The investigation and admissions by Mr. Courtney 
culminated in his guilty plea to all 20 counts of the indictment.
    As a result of this conviction, FDA served Mr. Courtney by 
certified mail on May 16, 2003, a notice proposing to permanently debar 
him from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal also offered 
Mr. Courtney an opportunity for a hearing on the proposal. The proposal 
was based on a finding, under section 306(a)(2)(B) of the act (21 
U.S.C. 335a(a)(2)(B)), that Mr. Courtney was convicted of a felony 
under Federal law for conduct otherwise relating to the regulation of 
any drug product under the act. Mr. Courtney was provided 30 days to 
file objections and request a hearing. Mr. Courtney did not request a 
hearing. His failure to request a hearing constitutes a waiver of his 
opportunity for a hearing and a waiver of any contentions concerning 
his debarment.

II. Findings and Order

    Therefore, the Director, Center for Drug Evaluation and Research, 
under section 306(a)(2)(B) of the act, and under authority delegated to 
her (21 CFR 5.34), finds that Mr. Robert Ray Courtney has been 
convicted of a felony under Federal law for conduct otherwise relating 
to the regulation of any drug product under the act.
    As a result of the foregoing finding, Mr. Robert Ray Courtney is 
permanently debarred 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 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 October 20, 2003 (see sections 306(c)(1)(B) and (c)(2)(A)(ii) 
and 201(dd) of the act (21 U.S.C. 321(dd))). Any person with an 
approved or pending drug product application who knowingly uses the 
services of Mr. Courtney, in any capacity, during his period of 
debarment, will be subject to civil money penalties (section 307(a)(6) 
of the act (21 U.S.C. 335b(a)(6))). If Mr. Courtney, during his period 
of debarment, provides services in any capacity to a person with an 
approved or pending drug product application, he will be subject to 
civil money penalties (section 307(a)(7) of the act). In addition, FDA 
will not accept or review any abbreviated new drug applications 
submitted by or with the assistance of Mr. Courtney during his period 
of debarment.
    Any application by Mr. Courtney for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. 03N-
0102 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: October 1, 2003.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 03-26385 Filed 10-17-03; 8:45 am]

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