[Federal Register Volume 86, Number 1 (Monday, January 4, 2021)]
[Notices]
[Pages 100-101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29044]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1415]


Sunrise Lee: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
permanently debarring Sunrise Lee 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. Lee was 
convicted of a felony under Federal law for conduct that relates to the 
regulation of a drug product under the FD&C Act. Ms. Lee was given 
notice of the proposed permanent debarment and an opportunity to 
request a hearing to show why she should not be debarred. As of October 
8, 2020 (30 days after receipt of the notice), Ms. Lee had not 
responded. Ms. Lee's failure to respond and request a hearing 
constitutes a waiver of her right to a hearing concerning this action.

DATES: This order is applicable January 4, 2021.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Staff, Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, (ELEM-4029) Division 
of Enforcement, Office of Strategic Planning and Operational Policy, 
Office of Regulatory Affairs, Food and Drug Administration, 12420 
Parklawn Dr., Rockville, MD 20857, 240-402-8743, or at 
[email protected].

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 from providing services in any 
capacity to a person that has an approved or pending drug product 
application 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 January 22, 2020, Ms. Lee was 
convicted as defined in section 306(l)(1) of the FD&C Act when judgment 
was entered against her in the U.S. District Court for the District of 
Massachusetts, after a jury verdict, on one count of Racketeering 
Conspiracy in violation of 18 U.S.C. 1962(d). The pattern of 
racketeering activity she was convicted of included engaging in 
multiple acts of mail fraud (18 U.S.C. 1341) and wire fraud (18 U.S.C. 
1343).
    The factual basis for this conviction is as follows: Ms. Lee held 
executive management positions, to include Regional Sales Manager for 
the Mid-Atlantic Region, Regional Director for the Central Region, and 
Regional Director for the West Region, of Insys Therapeutics Inc. 
(Insys), a Delaware Corporation, with headquarters in Chandler, 
Arizona. Insys developed and owned a drug called SUBSYS, a liquid 
formulation of fentanyl to be applied under the tongue. FDA approved 
SUBSYS for the management of breakthrough pain in adult cancer patients 
who are already receiving and are already tolerant to opioid therapy 
for their underlying persistent cancer pain. From 2012 and continuing 
through 2015, Ms. Lee participated in a conspiracy whereby employees of 
Insys bribed medical practitioners in various states to get those 
practitioners to increase prescribing SUBSYS to their patients, many of 
whom did not have cancer. Ms. Lee, along with her co-conspirators, 
measured the effect of these bribes on each practitioner's prescribing 
habits and on the revenue that each bribed practitioner generated for 
Insys. Ms. Lee, along with her co-conspirators, reduced or eliminated 
bribes paid to those practitioners who failed to meet the minimum 
prescription requirements or failed to generate enough revenue to 
justify additional bribes. To further this conspiracy, Ms. Lee's co-
conspirators mislead and defrauded health insurance providers to ensure 
those providers approved payment for SUBSYS. Insys achieved this goal 
by establishing the ``Insys Reimbursement Center,'' which was designed 
to shift the burden of seeking prior authorization for SUBSYS from 
practitioners to Insys. This allowed Insys to determine what medical 
information was presented to insurers. Ms. Lee's co-conspirators 
directed Insys employees to mislead insurers to obtain payment 
authorization.
    As a result of this conviction, FDA sent Ms. Lee by certified mail 
on August 3, 2020, a notice 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)(B) of the FD&C Act, that Ms. Lee was convicted 
of a felony under Federal law for conduct relating to the regulation of 
a drug product under the FD&C Act. The proposal also offered Ms. Lee 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 an election not to use 
the opportunity for a hearing and a waiver of any contentions 
concerning this action. Ms. Lee received the proposal on September 8, 
2020. She did not request a hearing within the timeframe prescribed by 
regulation and has, therefore, waived her opportunity for a hearing and 
any contentions concerning her debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal 
Food Operations, under section 306(a)(2)(B) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Ms. 
Sunrise Lee has been convicted of a felony under Federal law for 
conduct otherwise relating to the regulation of a drug product under 
the FD&C Act.
    As a result of the foregoing finding, Ms. Lee is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application, effective (see DATES) 
(see sections 306(a)(2)(B) and (c)(2)(A)(ii) of the FD&C Act). 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 Ms. Lee 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. Lee 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 application from 
Ms. Lee during her period of debarment, other than in connection with 
an audit under section

[[Page 101]]

306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act). Note that, 
for purposes of section 306 of the FD&C Act, a ``drug product'' is 
defined as a drug subject to regulation under section 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) (section 201(dd) of the 
FD&C Act (21 U.S.C. 321(dd))).
    Any application by Ms. Lee for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2020-N-1415 and sent to the Dockets Management Staff 
(see ADDRESSES). The public availability of information in these 
submissions is governed by 21 CFR 10.20.
    Publicly available submissions will be placed in the docket and 
will be viewable at https://www.regulations.gov or at the Dockets 
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday, 240-402-7500.

    Dated: December 28, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-29044 Filed 12-31-20; 8:45 am]
BILLING CODE 4164-01-P