01/11/1995

[Federal Register: January 11, 1995 (Volume 60, Number 7)]

[Notices]              

[Page 2767-2768]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr11ja95-70]

 

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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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