82 FR 49634 - Matthew Schroeder; Denial of Hearing; Final Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 206 (October 26, 2017)

Page Range		49634-49635
FR Document		2017-23275

The Food and Drug Administration (FDA) is denying Matthew Schroeder's (Schroeder's) request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Schroeder 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 Schroeder was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Schroeder failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.

Federal Register, Volume 82 Issue 206 (Thursday, October 26, 2017)

[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Pages 49634-49635]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-23275]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0961]

Matthew Schroeder; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is denying Matthew
Schroeder's (Schroeder's) request for a hearing and is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
permanently debarring Schroeder 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 Schroeder was convicted of a
felony under Federal law for conduct relating to the regulation of a
drug product under the FD&C Act. Schroeder failed to file with the
Agency information and analyses sufficient to create a basis for a
hearing concerning this action.

DATES: This order is applicable October 26, 2017.

ADDRESSES: Any application by Schroeder for special termination of
debarment under section 306(d) of the FD&C Act (application) may be
submitted as follows:

Electronic Submissions

Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your application,
that information will be posted on https://www.regulations.gov.
If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: Your application must include the Docket No. FDA-
2013-N-0961. An application will be placed in the docket and, unless
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of your application. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your application and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket, go to https://www.regulations.gov
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 between 9 a.m.

[[Page 49635]]

and 4 p.m., Monday through Friday. Publicly available submissions may
be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Julie Finegan, Office of Scientific
Integrity, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 1, Rm. 4218, Silver Spring, Maryland 20993, 301-796-8618.

SUPPLEMENTARY INFORMATION:

I. Background

On October 11, 2012, the U.S. District Court for the Northern
District of Georgia entered a criminal judgment against Matthew
Schroeder under his guilty plea. Schroeder pled guilty to a felony
under the FD&C Act, namely aiding and abetting, with the intent to
defraud or mislead, in the dispensing of phenazepam without a
prescription, resulting in the phenazapam being misbranded while held
for sale after shipment in interstate commerce in violation of sections
301(k), 503(b)(1), 303(a)(2) of the FD&C Act (21 U.S.C. 331(k),
353(b)(1) and 333(a)(2)) and 18 U.S.C. 2. Specifically, Schroeder,
through his company, Novel Research Supply, and eBay ID,
``finemineralsfossilssio2'' sold phenazepam and
methylenedioxypyrovalerone. Both are unapproved drugs and are used by
drug users for recreational purposes. According to FDA's September 24,
2014, letter to Schroeder, in August 2010, Kevin Lewis purchased
phenazepam on eBay from ``finemineralsfossilssio2'' and later died
after ingesting phenazepam through an injection.
Schroeder is subject to debarment based on a finding, under section
306(a)(2) of the FD&C Act (21 U.S.C. 335a(a)(2)), that he was convicted
of a felony under Federal law for conduct relating to the regulation of
a drug product under the FD&C Act. By the letter dated September 24,
2014, FDA notified Schroeder of a proposal to permanently debar him
from providing services in any capacity to a person having an approved
or pending drug product application. Schroeder requested a hearing on
the proposal and special termination of debarment. Schroeder
acknowledges his conviction under Federal law, but argues that multiple
mitigating factors merit a hearing or special termination of debarment.
Under the authority delegated to him by the Commissioner of Food
and Drugs, the Director of the Office of Scientific Integrity (OSI) has
considered Schroeder's request for a hearing. Hearings will not be
granted on issues of policy or law, on mere allegations, denials, or
general descriptions of positions and contentions, or on data and
information insufficient to justify the factual determination urged
(see 21 CFR 21.24(b)).
The Director of OSI considered Schroeder's arguments and concludes
that they are unpersuasive and fail to raise a genuine issue of fact
requiring a hearing.

II. Arguments

In his request for hearing, Schroeder first argues that he took
voluntary steps to mitigate the dangers posed by the drugs by putting
warnings against human consumption on the sales packaging and Web site.
Schroeder states that he discontinued drug sales after an FDA
investigator contacted him and that he fully disclosed all of his
wrongdoing. Schroeder next argues that he cooperated with
investigations and provided testimony against the drug suppliers.
Third, Schroeder argues that he ended all his activities concerning
drug sales and has not violated the FD&C Act since September 2010. He
also states that his phenazepam sales only spanned two months. Fourth,
Schroeder addresses Kevin Lewis' death and purchases. Schroeder states
that in the case against another drug supplier, the prosecutor
determined that Kevin Lewis died from long-term IV drug use, rather
than the phenazepam purchased from Schroeder's eBay account. Schroeder
also clarifies that Kevin Lewis purchased the phenazepam by using his
mother's eBay account. Finally, Schroeder alleges that he does not pose
a recidivism risk.
Section 306(a)(2) of the FD&C Act provides FDA with the authority
to debar an individual who has been convicted of certain Federal
felonies. The only relevant factual issue is whether Schroeder was
actually convicted of a felony under Federal law for conduct relating
to the development or approval of a drug product or otherwise relating
to the regulation of a drug product under the FD&C Act. Schroeder does
not dispute that he pled guilty to a felony under the FD&C Act,
specifically aiding and abetting, with the intent to defraud and
mislead, in the dispensing of phenazepam without a prescription,
resulting in the phenazepam being misbranded while held for sale after
shipment in interstate commerce. Accordingly, Schroeder's arguments
fail to raise a genuine and substantial issue of fact as to whether he
was convicted of a felony under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act.
Along with his request for a hearing, Schroeder also requested a
special termination of debarment. Under section 306(d), a debarred
individual may apply for special termination of debarment. While the
debarment period can be limited to less than permanent, the individual
must be debarred for at least 1 year. Schroeder is not yet debarred, so
his request for special termination of debarment is not appropriate for
consideration at this time.

III. Findings and Order

Therefore, the Director of OSI, under section 306(a)(2) of the FD&C
Act and under the authority delegated to him, finds that Matthew
Schroeder 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 findings, Matthew Schroeder is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application 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),
effective (see DATES) (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 21
U.S.C. 321(dd)). Any person with an approved or pending drug product
application who knowingly uses the services of Schroeder, in any
capacity during his period of debarment, will be subject to civil money
penalties. See section 307(a)(6) of the FD&C Act (21 U.S.C.
335b(a)(6)). If Schroeder, during his period of debarment, provides
services in any capacity to a person with an approved or pending drug
product application, he will be subject to civil money penalties. See
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 Schroeder during his period of
debarment.

Dated: October 20, 2017.
G. Matthew Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2017-23275 Filed 10-25-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 49635

and 4 p.m., Monday through Friday. denials, or general descriptions of Along with his request for a hearing,
Publicly available submissions may be positions and contentions, or on data Schroeder also requested a special
seen in the docket. and information insufficient to justify termination of debarment. Under
FOR FURTHER INFORMATION CONTACT: Julie the factual determination urged (see 21 section 306(d), a debarred individual
Finegan, Office of Scientific Integrity, CFR 21.24(b)). may apply for special termination of
Food and Drug Administration, 10903 The Director of OSI considered debarment. While the debarment period
New Hampshire Ave., Bldg. 1, Rm. Schroeder’s arguments and concludes can be limited to less than permanent,
4218, Silver Spring, Maryland 20993, that they are unpersuasive and fail to the individual must be debarred for at
301–796–8618. raise a genuine issue of fact requiring a least 1 year. Schroeder is not yet
SUPPLEMENTARY INFORMATION: hearing. debarred, so his request for special
II. Arguments termination of debarment is not
I. Background
appropriate for consideration at this
On October 11, 2012, the U.S. District In his request for hearing, Schroeder time.
Court for the Northern District of first argues that he took voluntary steps
Georgia entered a criminal judgment to mitigate the dangers posed by the III. Findings and Order
against Matthew Schroeder under his drugs by putting warnings against
human consumption on the sales Therefore, the Director of OSI, under
guilty plea. Schroeder pled guilty to a
felony under the FD&C Act, namely packaging and Web site. Schroeder section 306(a)(2) of the FD&C Act and
aiding and abetting, with the intent to states that he discontinued drug sales under the authority delegated to him,
defraud or mislead, in the dispensing of after an FDA investigator contacted him finds that Matthew Schroeder has been
phenazepam without a prescription, and that he fully disclosed all of his convicted of a felony under Federal law
resulting in the phenazapam being wrongdoing. Schroeder next argues that for conduct relating to the regulation of
misbranded while held for sale after he cooperated with investigations and a drug product under the FD&C Act.
shipment in interstate commerce in provided testimony against the drug As a result of the foregoing findings,
violation of sections 301(k), 503(b)(1), suppliers. Third, Schroeder argues that Matthew Schroeder is permanently
303(a)(2) of the FD&C Act (21 U.S.C. he ended all his activities concerning debarred from providing services in any
331(k), 353(b)(1) and 333(a)(2)) and 18 drug sales and has not violated the capacity to a person with an approved
U.S.C. 2. Specifically, Schroeder, FD&C Act since September 2010. He or pending drug product application
through his company, Novel Research also states that his phenazepam sales under section 505, 512, or 802 of the
Supply, and eBay ID, only spanned two months. Fourth,
FD&C Act (21 U.S.C. 355, 360b, or 382),
‘‘finemineralsfossilssio2’’ sold Schroeder addresses Kevin Lewis’ death
or under section 351 of the Public
phenazepam and and purchases. Schroeder states that in
the case against another drug supplier, Health Service Act (42 U.S.C. 262),
methylenedioxypyrovalerone. Both are
the prosecutor determined that Kevin effective (see DATES) (21 U.S.C.
unapproved drugs and are used by drug
Lewis died from long-term IV drug use, 335a(c)(1)(B) and (c)(2)(A)(ii) and 21
users for recreational purposes.
rather than the phenazepam purchased U.S.C. 321(dd)). Any person with an
According to FDA’s September 24, 2014,
letter to Schroeder, in August 2010, from Schroeder’s eBay account. approved or pending drug product
Kevin Lewis purchased phenazepam on Schroeder also clarifies that Kevin application who knowingly uses the
eBay from ‘‘finemineralsfossilssio2’’ and Lewis purchased the phenazepam by services of Schroeder, in any capacity
later died after ingesting phenazepam using his mother’s eBay account. during his period of debarment, will be
through an injection. Finally, Schroeder alleges that he does subject to civil money penalties. See
Schroeder is subject to debarment not pose a recidivism risk. section 307(a)(6) of the FD&C Act (21
based on a finding, under section Section 306(a)(2) of the FD&C Act U.S.C. 335b(a)(6)). If Schroeder, during
306(a)(2) of the FD&C Act (21 U.S.C. provides FDA with the authority to his period of debarment, provides
335a(a)(2)), that he was convicted of a debar an individual who has been services in any capacity to a person with
felony under Federal law for conduct convicted of certain Federal felonies. an approved or pending drug product
relating to the regulation of a drug The only relevant factual issue is application, he will be subject to civil
product under the FD&C Act. By the whether Schroeder was actually money penalties. See section 307(a)(7)
letter dated September 24, 2014, FDA convicted of a felony under Federal law of the FD&C Act (21 U.S.C. 335b(a)(7)).
notified Schroeder of a proposal to for conduct relating to the development In addition, FDA will not accept or
permanently debar him from providing or approval of a drug product or review any abbreviated new drug
services in any capacity to a person otherwise relating to the regulation of a applications submitted by or with the
having an approved or pending drug drug product under the FD&C Act. assistance of Schroeder during his
product application. Schroeder Schroeder does not dispute that he pled period of debarment.
requested a hearing on the proposal and guilty to a felony under the FD&C Act,
special termination of debarment. specifically aiding and abetting, with Dated: October 20, 2017.
Schroeder acknowledges his conviction the intent to defraud and mislead, in the G. Matthew Warren,
under Federal law, but argues that dispensing of phenazepam without a Director, Office of Scientific Integrity.
multiple mitigating factors merit a prescription, resulting in the [FR Doc. 2017–23275 Filed 10–25–17; 8:45 am]
hearing or special termination of phenazepam being misbranded while BILLING CODE 4164–01–P
debarment. held for sale after shipment in interstate
ethrower on DSK3G9T082PROD with NOTICES

Under the authority delegated to him commerce. Accordingly, Schroeder’s
by the Commissioner of Food and arguments fail to raise a genuine and
Drugs, the Director of the Office of substantial issue of fact as to whether he
Scientific Integrity (OSI) has considered was convicted of a felony under Federal
Schroeder’s request for a hearing. law for conduct relating to the
Hearings will not be granted on issues regulation of a drug product under the
of policy or law, on mere allegations, FD&C Act.

VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 9990 E:\FR\FM\26OCN1.SGM 26OCN1

Document Created: 2018-10-25 10:14:30
Document Modified: 2018-10-25 10:14:30

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 applicable October 26, 2017.
Contact		Julie Finegan, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4218, Silver Spring, Maryland 20993, 301-796-8618.
FR Citation		82 FR 49634

82 FR 49634 - Matthew Schroeder; Denial of Hearing; Final Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 206 (October 26, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration