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###### Department of Health and Human Services

###### Food and Drug Administration

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

# 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 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                           ( print 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