[Federal Register Volume 87, Number 91 (Wednesday, May 11, 2022)]
[Notices]
[Pages 28834-28836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10096]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1992]


Marwan Massouh; 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 or Agency) is denying 
Marwan Massouh's (Dr. Massouh's) request for a hearing and issuing an 
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
debarring Dr. Massouh for 3 years 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 Dr. Massouh was 
convicted of a misdemeanor under Federal law for causing the 
introduction or delivery for introduction into interstate commerce of 
drugs that were misbranded under the FD&C Act. Additionally, FDA finds 
that the conduct underlying Dr. Massouh's conviction undermines the 
process for the regulation of drugs. In determining the appropriateness 
and period of Dr. Massouh's debarment, FDA considered the relevant 
factors listed in the FD&C Act. Dr. Massouh 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 May 11, 2022.

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

Electronic Submissions

    <bullet> 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.
    <bullet> 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:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets

[[Page 28835]]

Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> 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: All applications must include the Docket No. FDA-
2018-N-1992. 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, 240-402-7500.
    <bullet> 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.govinfo.gov/content/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. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of 
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if FDA finds 
that (1) the individual has been convicted of a misdemeanor under 
Federal law for conduct relating to the regulation of drug products 
under the FD&C Act, and (2) the conduct underlying the conviction 
undermines the process for the regulation of drugs.
    In September 2013, Dr. Massouh pled guilty to a misdemeanor for 
introducing a misbranded drug into interstate commerce, in violation of 
section 301(a) of the FD&C Act (21 U.S.C. 331(a)). On October 16, 2013, 
the U.S. District Court for the Northern District of Ohio entered a 
judgment of conviction against Dr. Massouh for his violation of section 
301(a) and sentenced him to 1 year of probation. According to the 
criminal information to which Dr. Massouh pled guilty, between January 
3, 2006, and March 31, 2009, Dr. Massouh, an oncologist, purchased and 
received oncology drugs from a drug distributor located in Canada. Dr. 
Massouh's actions caused the introduction into interstate commerce of 
drugs that were misbranded under section 502(f)(1) of the FD&C Act (21 
U.S.C. 352(f)(1)) because their labeling did not bear adequate 
directions for use.
    By letter dated July 13, 2018, FDA's Office of Regulatory Affairs 
(ORA) notified Dr. Massouh of a proposal to debar him for 3 years from 
providing services in any capacity to a person that has an approved or 
pending drug product application. The proposal explained that FDA based 
the proposed debarment on his misdemeanor conviction. The proposal 
outlined findings concerning the four relevant factors that ORA 
considered in determining the appropriateness and period of debarment, 
as provided in section 306(c)(3) of the FD&C Act: (1) The nature and 
seriousness of the offense under section 306(c)(3)(A); (2) the nature 
and extent of management participation in the offense under section 
306(c)(3)(B); (3) the nature and extent of voluntary steps to mitigate 
the impact on the public under section 306(c)(3)(C); and (4) prior 
convictions under the FD&C Act or other acts involving matters within 
FDA's jurisdiction under section 306(c)(3)(F). ORA found that the first 
two were unfavorable factors and the last two were favorable factors 
for Dr. Massouh. The notice concluded that ``the unfavorable factors 
cumulatively outweigh the favorable factors and that debarment is 
appropriate.''
    The proposal offered Dr. Massouh the opportunity to request a 
hearing and provided him 30 days from the date of receipt of the letter 
to file the request and 60 days from the date of receipt of the letter 
to support his request with information sufficient to justify a 
hearing. In a submission dated August 17, 2018, through counsel, Dr. 
Massouh ``request[ed] a hearing relative to the Food and Drug 
Administration's Notice of Opportunity for Hearing'' but did not 
include information to support his request. Further, Dr. Massouh did 
not state whether information justifying the hearing request would be 
forthcoming. However, more than 60 days have elapsed since Dr. 
Massouh's receipt of ORA's letter, and he has not filed any 
information, or any legal or policy arguments, to support his request.
    Under the authority delegated to her by the Commissioner of Food 
and Drugs, the Acting Chief Scientist has considered Dr. Massouh'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 12.24(b)).
    Inasmuch as Dr. Massouh has not presented any information to 
support his hearing request, the Acting Chief Scientist concludes that 
Dr. Massouh has failed to raise a genuine and substantial issue of fact 
requiring a hearing. Therefore, the Acting Chief Scientist denies Dr. 
Massouh's request for a hearing. Further, Dr. Massouh has not presented 
any arguments concerning whether debarment is appropriate for his 
conviction or whether the proposed debarment period is appropriate. 
Based on the factual findings in the proposal to debar, the Acting 
Chief Scientist finds that a 3-year debarment period is appropriate.

II. Findings and Order

    Therefore, the Acting Chief Scientist, under section 
306(b)(2)(B)(i)(I) of the FD&C Act and under the authority delegated to 
her by the Commissioner of Food and Drugs, finds that (1) Dr. Massouh 
has been convicted of a misdemeanor under Federal law for causing the 
introduction into interstate commerce of prescription drugs that were 
misbranded under the FD&C Act and (2) that the conduct underlying the 
conviction undermines the process for the regulation of drugs. FDA 
considered

[[Page 28836]]

the applicable factors listed in section 306(c)(3) of the FD&C Act and 
determined that a 3-year debarment is appropriate.
    As a result of the foregoing findings, Dr. Massouh is debarred for 
3 years 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), effective (DATE 
of NOTICE), (see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and 21 
U.S.C. 321(dd)). Any person with an approved or pending drug 
application who knowingly uses the services of Dr. Massouh, 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 Dr. 
Massouh, 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 (section 
307(a)(7) of the FD&C Act). In addition, FDA will not accept or review 
any abbreviated new drug applications submitted by or with the 
assistance of Dr. Massouh during his period of debarment (section 
306(c)(1)(B) of the FD&C Act).

    Dated: April 21, 2022.
Jacqueline A. O'Shaughnessy,
Acting Chief Scientist.
[FR Doc. 2022-10096 Filed 5-10-22; 8:45 am]
BILLING CODE 4164-01-P