[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Notices]
[Pages 50636-50637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20561]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2099]


Lisa Marie Coroniti: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The U.S. Food and Drug Administration (FDA) is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
permanently debarring Lisa Coroniti 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 Ms. Coroniti was 
convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product. Ms. Coroniti was given notice of the 
proposed permanent debarment and an opportunity to request a hearing 
within the timeframe prescribed by regulation. Ms. Coroniti failed to 
request a hearing.

[[Page 50637]]

Ms. Coroniti's failure to request a hearing constitutes a waiver of her 
right to a hearing concerning this action.

DATES: This order is effective August 20, 2015.

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: Kenny Shade, Division of Enforcement, 
Office of Enforcement and Import Operations, Office of Regulatory 
Affairs (ELEM-4144), Food and Drug Administration, 12420 Parklawn 
Drive, Element Bldg., Rm. 4144, Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) 
requires debarment of an individual if FDA finds that the individual 
has been convicted of a felony under Federal law for conduct relating 
to the regulation of any drug product under the FD&C Act.
    On April 8, 2014, the U.S. District Court for the Eastern District 
of Virginia entered judgment against Ms. Coroniti for one count of 
introducing misbranded drugs into interstate commerce, in violation of 
sections 301(a) and 303(a)(2) of the FD&C Act (21 U.S.C. 331(a) and 
333(a)(2)).
    FDA's finding that debarment is appropriate is based on the felony 
conviction referenced herein. The factual basis for this conviction is 
as follows: Ms. Coroniti was a sales representative for Gallant Pharma 
International Inc. (Gallant Pharma) between June 2011 and August 2013, 
and was responsible for selling injectable cosmetic drugs and devices, 
and intravenous chemotherapy drugs, to doctors and hospitals in 
Philadelphia, Pennsylvania. Some of the drugs Ms. Coroniti facilitated 
the sale of were misbranded within the meaning of the FD&C Act.
    Ms. Coroniti admitted that she sold drugs which were not approved 
by the FDA for use on patients in the United States. She further 
admitted that the drugs she sold on behalf of Gallant Pharma were 
misbranded in that they did not bear adequate directions for use and 
were not subject to an exemption from that requirement, and they were 
accompanied by non-FDA approved packaging and inserts.
    Between June 2011 and August 2013, Ms. Coroniti admitted to selling 
misbranded drugs to 15 distinct doctors and medical practices in 
Pennsylvania and generated more than $1.1 million in illegal proceeds 
from these sales. She admitted that, as of April 26, 2013, she became 
willfully blind to the illegality of Gallant Pharma's business. 
Nonetheless, she continued her sales activity with Gallant Pharma until 
her arrest in August 2013.
    Between April 26, 2013, and August 7, 2013, Ms. Coroniti personally 
sold more than $367,000 in misbranded drugs and devices to doctors and 
medical practices in the Philadelphia, Pennsylvania, area. On or about 
July 30, 2013, Ms. Coroniti sold five vials of misbranded BOTOX to a 
doctor in Philadelphia, Pennsylvania, in exchange for $1,900.00, 
thereby causing a misbranded drug to be introduced into interstate 
commerce. She further admitted that the loss amount attributable to her 
personal sales was between $200,000 and $400,000.
    As a result of her conviction, on March 25, 2015, FDA sent Ms. 
Coroniti 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 
the finding, under section 306(a)(2)(B) of the FD&C Act, that Ms. 
Coroniti was convicted of a felony under Federal law for conduct 
related to the regulation of a drug product. FDA determined that Ms. 
Coroniti's felony conviction was related to the regulation of drug 
products because the conduct underlying her conviction, including 
intentionally introducing into interstate commerce misbranded drug 
products, undermined FDA's regulatory oversight over drug products 
marketed in the United States. The proposal also offered Ms. Coroniti 
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. The proposal was received on May 1, 2015. Ms. Coroniti failed 
to respond within the timeframe prescribed by regulation and has, 
therefore, waived her opportunity for a hearing and has waived any 
contentions concerning her debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import 
Operations, Office of Regulatory Affairs, under section 306(a)(2)(B) of 
the FD&C Act, under authority delegated to the Director (Staff Manual 
Guide 1410.35), finds that Lisa Marie Coroniti has been convicted of a 
felony under Federal law for conduct relating to the regulation of a 
drug product. Section 306(c)(2)(A)(ii) of the FD&C Act (21 U.S.C. 
335a(c)(2)(A)(ii)) requires that Ms.Coroniti's debarment be permanent.
    As a result of the foregoing findings, Lisa Marie Coroniti 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 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 section 201(dd), 306(c)(1)(B), and 
306(c)(2)(A)(ii) of the FD&C Act, (21 U.S.C. 321(dd), 335a(c)(1)(B), 
and 335a(c)(2)(A)(ii)). 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 Lisa Marie Coroniti, in 
any capacity during her 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 Ms. Coroniti 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 (21 U.S.C. 335b(a)(7))). In addition, FDA 
will not accept or review any abbreviated new drug applications 
submitted by or with the assistance of Lisa Marie Coroniti during her 
period of debarment (section 306(c)(1)(A) of the FD&C Act (21 U.S.C. 
335a(c)(1)(A))).
    Any application by Ms. Coroniti for special termination of 
debarment under section 306(d)(4) of the FD&C Act (21 U.S.C. 
335a(d)(4)) should be identified with Docket No. FDA-2014-N-2099 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.
    Publicly available submissions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20561 Filed 8-19-15; 8:45 am]
BILLING CODE 4164-01-P