[Federal Register Volume 60, Number 7 (Wednesday, January 11, 1995)]
[Notices]
[Pages 2767-2768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-695]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0285]


Andrew Morris; 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. Andrew Morris, 5731 Laurel Hill Dr., Indianapolis, IN 
46226, 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. Morris was convicted of a felony under Federal law for 
conduct relating to the development or approval, including the process 
for development or approval, of a drug product; and relating to the 
regulation of a drug product under the act. Mr. Morris has notified FDA 
that he acquiesces to debarment and, therefore, has waived his 
opportunity for a hearing concerning this action.

EFFECTIVE DATE: May 16, 1994.

ADDRESSES: Application for termination of debarment to the Dockets

[[Page 2768]]

Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Tamar S. Nordenberg, Center for Drug 
Evaluation and Research (HFD-366), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-2041.

SUPPLEMENTARY INFORMATION:

I. Background

    Mr. Andrew Morris, a former employee at Quad Pharmaceuticals, Inc. 
(Quad), first as a bench chemist and later as a manager in Quad's 
research and development department, pled guilty and was sentenced on 
May 13, 1994, for making a false statement to a U.S. Government agency, 
a Federal felony under 18 U.S.C. 1001, and for obstructing an agency 
proceeding, a Federal felony under 18 U.S.C. 1505. The basis for this 
conviction was as follows:

A. False Statement to a Federal Agency

    Mr. Morris, while working as a bench chemist at Quad, made a false 
representation in a certificate of analysis regarding the potency of a 
particular lot of the drug azathioprine sodium, which was submitted to 
FDA in support of an abbreviated new drug application (ANDA) for the 
drug.

B. Obstruction of an Agency Proceeding

    During an FDA audit of Quad's research and development department, 
Mr. Morris gathered and destroyed certain nonsterile samples of 
colistimethate sodium. These samples had previously been represented to 
FDA as sterile in batch production records. These records were prepared 
under Mr. Morris' supervision and were included in the ANDA for the 
drug product.
    Mr. Morris is subject to debarment based on a finding, under 
section 306(a)(2) of the act (21 U.S.C. 335a(a)(2)), that he was 
convicted of felonies under Federal law for conduct relating to the 
development, approval, and regulation of a drug product. Mr. Morris' 
false statements in documents used to support the ANDA's for the two 
Quad drug products relate to the development or approval of a drug 
product because FDA relies on the safety and efficacy data and 
information in the ANDA's in making its decisions whether to approve 
drug products. Mr. Morris' false statements and destruction of drug 
samples relate to the regulation of drug products because FDA's 
regulatory decisions about Quad drug products may have been affected by 
the conduct.
    In a letter received by FDA on May 16, 1994, Mr. Morris notified 
FDA of his acquiescence to debarment, as provided for in section 
306(c)(2)(B) of the act. A person subject to debarment is entitled to 
an opportunity for an agency hearing on disputed issues of material 
fact under section 306(i) of the act, but by acquiescing to debarment, 
Mr. Morris waived his opportunity for a hearing and any contentions 
concerning his debarment.

II. Findings and Order

    Therefore, the Interim Deputy Commissioner for Operations, under 
section 306(a) of the act, and under authority delegated to her (21 CFR 
5.20), finds that Mr. Andrew Morris has been convicted of a felony 
under Federal law for conduct relating to the development or approval, 
including the process for development or approval, of a drug product 
(21 U.S.C. 335a(a)(2)(A)); and relating to the regulation of a drug 
product (21 U.S.C. 335a(a)(2)(B)).
    As a result of the foregoing findings and based on his notification 
of acquiescence, Mr. Andrew Morris is permanently debarred from 
providing services in any capacity to a person with an approved or 
pending drug product application under section 505, 507, 512, or 802 of 
the act (21 U.S.C. 355, 357, 360b, or 382), or under section 351 of the 
Public Health Service Act (42 U.S.C. 262), effective May 16, 1994, the 
date of notification of acquiescence (21 U.S.C. 335a(c)(1)(B) and 
(c)(2)(A)(ii) and 21 U.S.C. 321(ee)). Any person with an approved or 
pending drug product application who knowingly uses the services of Mr. 
Morris, in any capacity, during his period of debarment, will be 
subject to civil money penalties. If Mr. Morris, 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. In addition, FDA will not accept or review any 
ANDA's submitted by or with the assistance of Mr. Morris during his 
period of debarment.
    Any application by Mr. Morris for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. 94N-
0285 and sent to the Dockets Management Branch (address above). 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 Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 4, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-695 Filed 1-10-95; 8:45 am]
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