80 FR 50636 - Lisa Marie Coroniti: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 161 (August 20, 2015)

Page Range		50636-50637
FR Document		2015-20561

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

Federal Register, Volume 80 Issue 161 (Thursday, August 20, 2015)

[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Notices]
[Pages 50636-50637]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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

50636 Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Notices

On page 48326, in the first column, intend to identify and further develop 1. How can we improve nomenclature
the numbered list is corrected to read as these best practices in a technical guide in the IID (e.g., use of preferred
follows: or draft guidance to be issued at a later ingredient names and synonyms in the
1. DUREZOL (difluprednate date. database)?
ophthalmic emulsion) 0.05%, DATES: Submit either electronic or 2. How should we identify excipient
2. Phenylephrine Hydrochloride written comments by October 19, 2015. amounts listed in the IID?
Ophthalmic Solution, ADDRESSES: Submit electronic
3. How should we reflect updates to
3. ZYLET (loteprednol etabonate and comments to http:// the current IID to ensure completeness
tobramycin ophthalmic suspension), www.regulations.gov. Submit written and accuracy?
4. BETHKIS (tobramycin Inhalation 4. Should we restructure the IID, and
comments to the Division of Dockets
Solution), if so, how?
Management (HFA–305), Food and Drug 5. Are there additional suggestions or
5. INTELENCE (etravirine),
Administration, 5630 Fishers Lane, Rm. comments for IID improvement?
6. PREZISTA (darunavir),
1061, Rockville, MD 20852. Identify FDA will consider all comments
7. VIRAMUNE XR (nevirapine),
8. EPIDUO (adapalene and benzoyl comments with the docket number submitted. FDA generally will not
peroxide), found in brackets in the heading of this respond directly to the person or
9. EXJADE (deferasirox), document. organization submitting the comment.
10. DOTAREM (gadoterate FOR FURTHER INFORMATION CONTACT:
Elizabeth Giaquinto, Center for Drug III. Comments
meglumine),
11. FYCOMPA (perampanel), Evaluation and Research, Food and Interested persons may submit either
12. RECOTHROM (thrombin, topical Drug Administration, 10903 New electronic comments regarding this
[recombinant]), Hampshire Ave., Bldg. 75, Rm. 1670, document to http://www.regulations.gov
13. PREVNAR 13 (Pneumococcal 13- Silver Spring, MD 20993–0002, 240– or written comments to the Division of
valent Conjugate Vaccine [Diphtheria 402–7930. Dockets Management (see ADDRESSES). It
CRM197 Protein]), SUPPLEMENTARY INFORMATION: is only necessary to send one set of
14. PLEXIMMUNE, comments. Identify comments with the
15. ELANA SURGICAL KIT (HUD), I. Background docket number found in brackets in the
16. BERLIN HEART EXCOR The IID provides information on heading of this document. Received
PEDIATRIC VENTRICULAR ASSIST inactive ingredients in FDA-approved comments may be seen in the Division
DEVICE (VAD), drug products. An inactive ingredient, of Dockets Management between 9 a.m.
17. ENTERRA THERAPY SYSTEM, or excipient, is any component of a drug and 4 p.m., Monday through Friday, and
and product other than an active ingredient will be posted to the docket at http://
18. CONTEGRA Pulmonary Valved (21 CFR 210.3(b)(8)). Generally, the IID www.regulations.gov.
Conduit. identifies excipients that appear in Dated: August 14, 2015.
Dated: August 14, 2015. approved drug products for a particular Leslie Kux,
Jill Hartzler Warner, dosage form and route of
Associate Commissioner for Policy.
Associate Commissioner for Special Medical
administration.
In September 2011, FDA created the [FR Doc. 2015–20556 Filed 8–19–15; 8:45 am]
Programs.
IID Working Group to develop a set of BILLING CODE 4164–01–P
[FR Doc. 2015–20541 Filed 8–19–15; 8:45 am]
questions and answers to facilitate use
BILLING CODE 4164–01–P
of the IID. During the development of
questions and answers, FDA has worked DEPARTMENT OF HEALTH AND
with the International Pharmaceutical HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES Excipients Council (IPEC Americas).1 Food and Drug Administration
FDA is opening a public docket to
Food and Drug Administration solicit comments from additional [Docket No. FDA–2014–N–2099]
stakeholders on enhancing the utility
[Docket No. FDA–2015–N–2986] and usability of the IID. FDA will then Lisa Marie Coroniti: Debarment Order
develop a comprehensive technical AGENCY: Food and Drug Administration,
Technical Document for Using the
guide or draft guidance for industry and HHS.
Inactive Ingredient Database;
reviewers. ACTION: Notice.
Establishment of a Public Docket
II. Establishment of a Public Docket and SUMMARY: The U.S. Food and Drug
AGENCY: Food and Drug Administration, Request for Comments
HHS. Administration (FDA) is issuing an
ACTION: Notice; establishment of public To help FDA identify and ultimately order under the Federal Food, Drug, and
docket; request for comments. establish best practices and issue a Cosmetic Act (the FD&C Act)
technical guide or draft guidance, FDA permanently debarring Lisa Coroniti
SUMMARY: The Food and Drug is requesting public comments regarding from providing services in any capacity
Administration (FDA, or the Agency) is the enhancement of the IID. to a person that has an approved or
announcing the establishment of a FDA is requesting comments and pending drug product application. FDA
public docket to receive comments from supporting information, including bases this order on a finding that Ms.
interested parties on enhancing the proposed questions and proposed Coroniti was convicted of a felony
tkelley on DSK3SPTVN1PROD with NOTICES

utility and usability of the Inactive answers, on the following topics related under Federal law for conduct relating
Ingredient Database (IID) (also known as to the IID: to the regulation of a drug product. Ms.
the Inactive Ingredient Guide). These Coroniti was given notice of the
1 See Meetings between FDA and the
comments will help FDA identify best proposed permanent debarment and an
International Pharmaceutical Excipients Council
practices to assist Agency staff in (IPEC), available at http://www.fda.gov/aboutfda/
opportunity to request a hearing within
designing the IID and maintaining the centersoffices/officeofmedicalproductsandtobacco/ the timeframe prescribed by regulation.
information contained therein. We cder/ucm380688.htm. Ms. Coroniti failed to request a hearing.

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Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Notices 50637

Ms. Coroniti’s failure to request a and generated more than $1.1 million in for conduct relating to the regulation of
hearing constitutes a waiver of her right illegal proceeds from these sales. She a drug product. Section 306(c)(2)(A)(ii)
to a hearing concerning this action. admitted that, as of April 26, 2013, she of the FD&C Act (21 U.S.C.
DATES: This order is effective August 20, became willfully blind to the illegality 335a(c)(2)(A)(ii)) requires that
2015. of Gallant Pharma’s business. Ms.Coroniti’s debarment be permanent.
ADDRESSES: Submit applications for Nonetheless, she continued her sales
As a result of the foregoing findings,
termination of debarment to the activity with Gallant Pharma until her
arrest in August 2013. Lisa Marie Coroniti is permanently
Division of Dockets Management (HFA– debarred from providing services in any
305), Food and Drug Administration, Between April 26, 2013, and August
7, 2013, Ms. Coroniti personally sold capacity to a person with an approved
5630 Fishers Lane, Rm. 1061, Rockville, or pending drug product application
more than $367,000 in misbranded
MD 20852. under sections 505, 512, or 802 of the
drugs and devices to doctors and
FOR FURTHER INFORMATION CONTACT: FD&C Act (21 U.S.C. 355, 360b, or 382),
medical practices in the Philadelphia,
Kenny Shade, Division of Enforcement, Pennsylvania, area. On or about July 30, or under section 351 of the Public
Office of Enforcement and Import 2013, Ms. Coroniti sold five vials of Health Service Act (42 U.S.C. 262),
Operations, Office of Regulatory Affairs misbranded BOTOX to a doctor in effective (see DATES) (see section
(ELEM–4144), Food and Drug Philadelphia, Pennsylvania, in exchange 201(dd), 306(c)(1)(B), and
Administration, 12420 Parklawn Drive, for $1,900.00, thereby causing a 306(c)(2)(A)(ii) of the FD&C Act, (21
Element Bldg., Rm. 4144, Rockville, MD misbranded drug to be introduced into U.S.C. 321(dd), 335a(c)(1)(B), and
20857, 301–796–4640. interstate commerce. She further 335a(c)(2)(A)(ii)). Any person with an
SUPPLEMENTARY INFORMATION: admitted that the loss amount approved or pending drug product
I. Background attributable to her personal sales was application who knowingly employs or
between $200,000 and $400,000. retains as a consultant or contractor, or
Section 306(a)(2)(B) of the FD&C Act As a result of her conviction, on
(21 U.S.C. 335a(a)(2)(B)) requires otherwise uses the services of Lisa
March 25, 2015, FDA sent Ms. Coroniti
debarment of an individual if FDA finds a notice by certified mail proposing to Marie Coroniti, in any capacity during
that the individual has been convicted permanently debar her from providing her debarment, will be subject to civil
of a felony under Federal law for services in any capacity to a person that money penalties (section 307(a)(6) of the
conduct relating to the regulation of any has an approved or pending drug FD&C Act (21 U.S.C. 335b(a)(6))). If Ms.
drug product under the FD&C Act. product application. The proposal was Coroniti provides services in any
On April 8, 2014, the U.S. District based on the finding, under section capacity to a person with an approved
Court for the Eastern District of Virginia 306(a)(2)(B) of the FD&C Act, that Ms. or pending drug product application
entered judgment against Ms. Coroniti Coroniti was convicted of a felony during her period of debarment she will
for one count of introducing misbranded under Federal law for conduct related to be subject to civil money penalties
drugs into interstate commerce, in the regulation of a drug product. FDA (section 307(a)(7) of the FD&C Act (21
violation of sections 301(a) and determined that Ms. Coroniti’s felony U.S.C. 335b(a)(7))). In addition, FDA
303(a)(2) of the FD&C Act (21 U.S.C. conviction was related to the regulation will not accept or review any
331(a) and 333(a)(2)). of drug products because the conduct abbreviated new drug applications
FDA’s finding that debarment is underlying her conviction, including submitted by or with the assistance of
appropriate is based on the felony intentionally introducing into interstate Lisa Marie Coroniti during her period of
conviction referenced herein. The commerce misbranded drug products, debarment (section 306(c)(1)(A) of the
factual basis for this conviction is as undermined FDA’s regulatory oversight
follows: Ms. Coroniti was a sales FD&C Act (21 U.S.C. 335a(c)(1)(A))).
over drug products marketed in the
representative for Gallant Pharma United States. The proposal also offered Any application by Ms. Coroniti for
International Inc. (Gallant Pharma) Ms. Coroniti an opportunity to request special termination of debarment under
between June 2011 and August 2013, a hearing, providing her 30 days from section 306(d)(4) of the FD&C Act (21
and was responsible for selling the date of receipt of the letter in which U.S.C. 335a(d)(4)) should be identified
injectable cosmetic drugs and devices, to file the request, and advised her that with Docket No. FDA–2014–N–2099
and intravenous chemotherapy drugs, to failure to request a hearing constituted and sent to the Division of Dockets
doctors and hospitals in Philadelphia, a waiver of the opportunity for a hearing Management (see ADDRESSES). All such
Pennsylvania. Some of the drugs Ms. and of any contentions concerning this submissions are to be filed in four
Coroniti facilitated the sale of were action. The proposal was received on copies. The public availability of
misbranded within the meaning of the May 1, 2015. Ms. Coroniti failed to information in these submissions is
FD&C Act. respond within the timeframe governed by 21 CFR 10.20.
Ms. Coroniti admitted that she sold prescribed by regulation and has,
drugs which were not approved by the Publicly available submissions may
therefore, waived her opportunity for a
FDA for use on patients in the United be seen in the Division of Dockets
hearing and has waived any contentions
States. She further admitted that the concerning her debarment (21 CFR part Management between 9 a.m. and 4 p.m.,
drugs she sold on behalf of Gallant 12). Monday through Friday.
Pharma were misbranded in that they Dated: August 14, 2015.
did not bear adequate directions for use II. Findings and Order
Leslie Kux,
and were not subject to an exemption Therefore, the Director, Office of
Associate Commissioner for Policy.
tkelley on DSK3SPTVN1PROD with NOTICES

from that requirement, and they were Enforcement and Import Operations,
[FR Doc. 2015–20561 Filed 8–19–15; 8:45 am]
accompanied by non-FDA approved Office of Regulatory Affairs, under
packaging and inserts. section 306(a)(2)(B) of the FD&C Act, BILLING CODE 4164–01–P
Between June 2011 and August 2013, under authority delegated to the
Ms. Coroniti admitted to selling Director (Staff Manual Guide 1410.35),
misbranded drugs to 15 distinct doctors finds that Lisa Marie Coroniti has been
and medical practices in Pennsylvania convicted of a felony under Federal law

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Document Created: 2015-12-15 11:08:24
Document Modified: 2015-12-15 11:08:24

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		This order is effective August 20, 2015.
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.
FR Citation		80 FR 50636

80 FR 50636 - Lisa Marie Coroniti: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 161 (August 20, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration