[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Notices]
[Pages 19100-19101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8152]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0450]


Maria Carmen Palazzo: 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 FD&C Act) 
permanently debarring Maria Carmen Palazzo, M.D. from providing 
services in any capacity to a person that has an approved or pending 
drug product application. We base this order on a finding that Dr. 
Palazzo was convicted of felonies under Federal law for conduct 
relating to the development or approval, including the process for 
development or approval, of any drug product or otherwise relating to 
the regulation of any drug product under the FD&C Act. Dr. Palazzo was 
given notice of the proposed permanent debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Dr. 
Palazzo failed to respond. Dr. Palazzo's failure to respond constitutes 
a waiver of her right to a hearing concerning this action.

DATES: This order is effective April 6, 2011.

ADDRESSES: Submit applications for special 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: Kenny Shade, Office of Regulatory 
Affairs (HFC-230), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(a)(2)(A) and (B) of the FD&C Act (21 U.S.C. 
335a(a)(2)(A) and (B)) require debarment of an individual if FDA finds 
that the individual 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 any drug product or otherwise 
relating to the regulation of any drug product under the FD&C Act.
    On August 19, 2010, the United States District Court for the 
Eastern District of Louisiana accepted Dr. Palazzo's plea of guilty, 
and entered judgment against her for 15 counts of failure to prepare 
and maintain records with intent to defraud or mislead in violation of 
21 U.S.C. 331(e), 333(a)(2), and 18 U.S.C. 2.
    FDA's finding that debarment is appropriate is based on the felony 
convictions referenced herein for conduct relating to the development 
or approval, including the process for development or approval, of any 
drug product and otherwise relating to the regulation of any drug 
product under the FD&C Act. The factual basis for those convictions is 
as follows: Dr. Palazzo was a licensed medical doctor with offices 
located in New Orleans, Louisiana. SmithKline Beecham, Corporation, 
d.b.a. GlaxoSmithKline (SKB) was a pharmaceutical company engaged in 
developing, testing, and marketing pharmaceutical products including 
Paroxetine, also known as ``Paxil.'' Under the FD&C Act and its 
implementing regulations, SKB had to apply to FDA for approval to 
market Paxil. SKB was required to demonstrate, through clinical 
investigations in which Paxil was given to human subjects, the safety 
and effectiveness of the drug in order to receive approval from FDA.
    SKB hired Dr. Palazzo to be a clinical investigator for the Paxil 
study. As a participating investigator, Dr. Palazzo signed, on multiple 
occasions, an FDA Form 1572 committing to conduct the study in 
accordance with the study protocol, to personally conduct or supervise 
the investigation, and to comply with FDA regulations. Dr. Palazzo 
agreed to conduct the study in strict compliance with the criteria set 
forth in the study protocol, to personally review all Case Report 
Forms, and, in return, SKB agreed to pay for each subject who completed 
the study.
    FDA regulations require that a clinical investigator on a drug 
study prepare and maintain adequate and accurate case histories that 
record all observations and other data pertinent to the investigation 
on each study subject and provide that information to the drug sponsor. 
From on or about October 23, 2000, through May 24, 2001, Dr. Palazzo, 
with intent to defraud and mislead, failed to prepare and maintain 
records required under 21 U.S.C. 355(i) and 21 CFR 312.62(b), all in 
violation of 21 U.S.C. 331(e), 333(a)(2), and 18 U.S.C. 2.
    As a result of her convictions, on January 11, 2011, FDA sent Dr. 
Palazzo a notice by certified mail proposing to permanently debar her 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
a finding, under section 306(a)(2)(A) and (B) of the FD&C Act, that Dr. 
Palazzo was convicted of felonies under Federal law for conduct 
relating to the development or approval, including the process for 
development or approval, of any drug product and otherwise relating to 
the regulation of any drug product under the FD&C Act. The proposal 
also offered Dr. Palazzo an opportunity to request a hearing, providing 
her 30 days from the date of receipt of the letter in which to file the 
request, and advised her that failure to request a hearing constituted 
a waiver of the opportunity for a hearing and of any contentions 
concerning this action. Dr. Palazzo failed to respond within the 
timeframe prescribed by regulation and has, therefore, waived her 
opportunity for a hearing and waived any contentions concerning her 
debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(a)(2)(A) and(B) of the FD&C Act, 
under authority delegated to the Acting Director (Staff Manual Guide 
1410.35), finds that Maria Carmen Palazzo has been convicted of 
felonies under Federal law for conduct relating to the development or 
approval, including the process for development or approval, of any 
drug product and otherwise relating to the regulation of any drug 
product under the FD&C Act.
    As a result of the foregoing finding, Dr. Palazzo 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 FD&C

[[Page 19101]]

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, (see DATES) (see 
sections 306(c)(1)(B), (c)(2)(A)(ii), and 201(dd) of the FD&C Act (21 
U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii), and 321(dd))). Any person with an 
approved or pending drug product application who knowingly employs or 
retains as a consultant or contractor, or otherwise uses the services 
of Dr. Palazzo, in any capacity during Dr. Palazzo's debarment, will be 
subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 
U.S.C. 335b(a)(6))). If Dr. Palazzo provides services in any capacity 
to a person with an approved or pending drug product application during 
her period of debarment she will be subject to civil money penalties 
(section 307(a)(7) of the FD&C Act). In addition, FDA will not accept 
or review any abbreviated new drug applications submitted by or with 
the assistance of Dr. Palazzo during her period of debarment (section 
306(c)(1)(B) of the FD&C Act.
    Any application by Dr. Palazzo for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2010-N-0450 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: March 28, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-8152 Filed 4-5-11; 8:45 am]
BILLING CODE 4160-01-P