[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Pages 49634-49635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23275]


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

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.

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

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.gpo.gov/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