[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15792-15794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05715]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3608]
Stephen Kalinoski: 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 Stephen Kalinoski 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. Kalinoski was
convicted of a felony for conduct that relates to the regulation of a
drug product under the FD&C Act. Mr. Kalinoski was given notice of the
proposed permanent debarment and an opportunity to request a hearing
within the timeframe prescribed by regulation. Mr. Kalinoski failed to
respond. Mr. Kalinoski's failure to request a hearing within the
prescribed timeframe
[[Page 15793]]
constitutes a waiver of his right to a hearing concerning this action.
DATES: This order is applicable March 19, 2020.
ADDRESSES: Submit applications for special termination of debarment to
the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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 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 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 July 14,
2017, Mr. Kalinoski entered a plea of guilty to one count of conspiracy
to commit wire fraud, a felony offense, in violation of 18 U.S.C. 371,
and on December 19, 2017, judgment was entered against Mr. Kalinoski in
the U.S. District Court for the Eastern District of New York.
The factual basis for this conviction is as follows: Mr. Kalinoski
was the director of pharmacy and registered pharmacist in charge at Med
Prep Consulting, Inc. (Med Prep), a medical drug repackager located and
incorporated in New Jersey in 1994. Med Prep manufactured, repackaged,
processed, packed, labeled, held, compounded, and distributed various
drug products, including pain management medications, anesthesia and
operating room drugs, and oncology and dialysis drugs. Mr. Kalinoski
worked at Med Prep from approximately 2003 to its closing in the summer
of 2013 and was in charge of repackaging and compounding operations and
other drug-processing activities.
Between approximately January 2007 and April 2013, Mr. Kalinoski
knowingly and intentionally conspired with other individuals to devise
a scheme and artifice to defraud healthcare providers and to obtain
money and property from them by means of materially false and
fraudulent pretenses, representations, and promises, and for the
purpose of executing such scheme and artifice, and attempting to do so,
to transmit and cause to be transmitted, by means of wire communication
in interstate commerce, writings, signs, signals, pictures, and sounds.
Specifically, during this time period, Mr. Kalinoski conspired with
others to introduce and introduced, or caused the introduction of,
adulterated and misbranded drugs into interstate commerce, all with the
intent to defraud and mislead healthcare providers. The adulterated
drugs Mr. Kalinoski introduced or caused to be introduced into
interstate commerce were adulterated because they were prepared,
packed, and held under insanitary conditions and because the drugs
consisted in whole or in part of a filthy, putrid, and decomposed
substance. The misbranded drugs Mr. Kalinoski introduced or caused to
be introduced in interstate commerce were misbranded because the drugs
were dangerous to health when used as labeled and because the labeling
on the drugs regarding use by dates and the strength of the ingredients
were false and misleading. Mr. Kalinoski assured healthcare providers
that they were receiving drug products from Med Prep that were produced
in full compliance with the law, were compounded and packaged in
compliance with chapter 797 of the United States Pharmacopeia (USP 797)
and would be safe for patients. Mr. Kalinoski also told healthcare
providers that the beyond use dates that Mr. Kalinoski assigned to
sterile drug products were supported by sterility testing that
satisfied the requirements of USP 797. These representations were made
in, among other places, quarterly reports that were sent by email to
healthcare providers and on Med Prep's website. Mr. Kalinoski did not
inform healthcare providers of failures to comply with USP 797 and
basic sterility practices, and breaches of aseptic technique in Med
Prep's cleanroom, which occurred repeatedly at Med Prep's facility.
By engaging in this conduct, Mr. Kalinoski violated Federal and
State law applicable to drug preparation and created serious risks for
patients who were being treated for cancer and other illnesses. Mr.
Kalinoski misrepresented the quality of Med Prep's drug processing and
repackaging operation to increase market share, and he engaged in
substandard practices to save money and increase his profits. Relying
on these misrepresentations and omissions, healthcare providers paid
Med Prep approximately $34,970,881 for its services between
approximately 2007 and 2012.
Based on his conviction, FDA sent Mr. Kalinoski by certified mail
on September 27, 2019, 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. Kalinoski was
convicted, as set forth in section 306(l)(1) of the FD&C Act, 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.
Kalinoski 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 file a timely request for a hearing
constituted a waiver of the opportunity for a hearing and of any
contentions concerning this action. Mr. Kalinoski received the proposal
on October 3, 2019. Mr. Kalinoski did not request a hearing 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 Stephen
Kalinoski has been convicted of a felony under Federal law for conduct
relating to the regulation of a drug product under the FD&C Act.
As a result of the foregoing finding, Stephen Kalinoski 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), applicable (see DATES) (see sections 201(dd) and 306(c)(1)(B) and
(c)(2)(A)(ii) of the FD&C Act (21 U.S.C. 321(dd) and 335a(c)(1)(B) and
(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 in any capacity the services of Stephen
Kalinoski 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. Kalinoski 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 applications from Mr. Kalinoski during his
period of
[[Page 15794]]
debarment (section 306(c)(1)(B) of the FD&C Act).
Any application by Mr. Kalinoski for special termination of
debarment under section 306(d)(4) of the FD&C Act should be identified
with Docket No. FDA-2019-N-3608 and sent to the Dockets Management
Staff (see ADDRESSES). All such submissions are to be filed in one
copy. The public availability of information in these submissions is
governed by 21 CFR 10.20.
Publicly available submissions may be seen in the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Dated: March 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05715 Filed 3-18-20; 8:45 am]
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