Notice2022-10096
Marwan Massouh; Denial of Hearing; Final Debarment Order
Primary source
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Published
May 11, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 91 (Wednesday, May 11, 2022)</title>
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[Federal Register Volume 87, Number 91 (Wednesday, May 11, 2022)]
[Notices]
[Pages 28834-28836]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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
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</html>Indexed from Federal Register on May 11, 2022.
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