[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Pages 76084-76085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26226]
[[Page 76084]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1347]
Michael L. Babich: 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 Michael L. Babich 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 Mr. Babich was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Mr. Babich was given
notice of the proposed permanent debarment and an opportunity to
request a hearing to show why he should not be debarred. As of
September 2, 2020 (30 days after receipt of the notice), Mr. Babich had
not responded. Mr. Babich's failure to respond and request a hearing
constitutes a waiver of his right to a hearing concerning this action.
DATES: This order is applicable November 27, 2020.
ADDRESSES: Submit applications for special termination of debarment to
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857, [email protected], or at 240-
402-8743.
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, Mr. Babich was
convicted as defined in section 306(l)(1) of the FD&C Act when judgment
was entered against him in the U.S. District Court for the District of
Massachusetts, after his plea of guilty, to one count of conspiracy in
violation of 18 U.S.C. 371 and one count of wire fraud in violation of
18 U.S.C. 1341.
The factual basis for this conviction is as follows: Mr. Babich was
the President and Chief Executive Officer 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 May 2012 and
continuing until December 2015, Mr. Babich conspired with other
employees of Insys to bribe and provide kickbacks, often mailed through
the U.S. Postal service, to medical practitioners in various states to
get those practitioners to increase prescribing SUBSYS to their
patients, many of whom did not have cancer. The bribes and kickbacks
took various forms, including honoraria for the practitioners'
participation in educational events and payment of the practitioner's
staff salaries. To further this conspiracy, Mr. Babich along with his
co-conspirators devised a scheme whereby Insys executives conspired to
mislead and defraud health insurance providers to ensure those
providers approved payment for SUBSYS when it was prescribed for non-
cancer patients.
As a result of this conviction FDA sent Mr. Babich, by certified
mail on July 16, 2020, a notice proposing to permanently debar him 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 Mr. Babich 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 Mr. Babich an opportunity to request a hearing, providing him
30 days from the date of receipt of the letter in which to file the
request, and advised him 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. Mr. Babich received the
proposal on August 3, 2020. Mr. Babich did not request a hearing within
the timeframe prescribed by regulation and has, therefore, waived his
opportunity for a hearing and any contentions concerning his 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 Mr.
Babich 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, Mr. Babich 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 306(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 Mr. Babich, in any capacity during his
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 Mr. Babich provides
services in any capacity to a person with an approved or pending drug
product application during his period of debarment he 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 Mr. Babich during his period of debarment, other than
in connection with an audit under section 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, 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 Mr. Babich for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2020-N-1347 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.
[[Page 76085]]
Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26226 Filed 11-25-20; 8:45 am]
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