Notice2026-19654
Naveed Aslam: Final Debarment Order
Primary source
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Published
September 25, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Naveed Aslam 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. Aslam was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Dr. Aslam was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of July 9, 2026 (30 days after receipt of the notice), Dr. Aslam has not responded. Dr. Aslam's failure to respond and request a hearing constitutes a waiver of Dr. Aslam's right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 91 Issue 185 (Friday, September 25, 2026)</title>
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[Federal Register Volume 91, Number 185 (Friday, September 25, 2026)]
[Notices]
[Pages 60961-60962]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19654]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-7395]
Naveed Aslam: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Naveed Aslam 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. Aslam was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Dr. Aslam was given
notice of the proposed debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation. As of July 9,
2026 (30 days after receipt of the notice), Dr. Aslam has not
responded. Dr. Aslam's failure to respond and request a hearing
constitutes a waiver of Dr. Aslam's right to a hearing concerning this
matter.
DATES: This order is applicable September 25, 2026.
ADDRESSES: Any application by Dr. Aslam for special termination of
debarment under section 306(d)(4) of the FD&C Act (21 U.S.C.
335a(d)(4)) may be submitted at any time 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
<bullet> 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.
<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-
2025-N-7395. Received applications will be placed in the docket and,
except for those 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 comments 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: Jaime Espinosa, Division of Field
Enforcement, Office of Field Regulatory Operations, Office of
Inspections and Investigations, Food and Drug Administration, 240-402-
8743, or <a href="/cdn-cgi/l/email-protection#593d3c3b382b343c372d2a193f3d387731312a773e362f"><span class="__cf_email__" data-cfemail="cca8a9aeadbea1a9a2b8bf8caaa8ade2a4a4bfe2aba3ba">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act requires debarment of an
individual from providing services in any capacity to a person that has
an approved or pending drug product application if FDA finds that the
individual has been convicted of a felony under Federal law
[[Page 60962]]
for conduct relating to the regulation of any drug product under the
FD&C Act. On November 17, 2025, Dr. Aslam was convicted as defined in
section 306(l)(1) of the FD&C Act in the U.S. District Court for the
Eastern District of Michigan, when the court entered judgment against
him after his plea of guilty to one count of the illegal sale or trade
of prescription drugs, in violation of 21 U.S.C. 333(a)(2) (section
303(a)(2) of the FD&C Act), which constitutes a felony under Federal
law.
The underlying facts supporting the conviction are as follows: As
described in the Indictment and Plea Agreement in Dr. Aslam's case, Dr.
Aslam was a licensed oncologist practicing medicine at Somerset
Hematology Oncology, P.C. (Somerset). Dr. Aslam and Somerset were
healthcare entities under 21 CFR 203.3(q) because Dr. Aslam, through
Somerset, provided medical treatment to patients. Through Somerset, Dr.
Aslam had access to several prescription cancer medications that he
could buy from drug distributors, including Distributor-1, a publicly
traded company that distributed prescription drugs including
Enhertu[supreg], Padcev[supreg], Poteligo[supreg], Tivdak[supreg], and
Trodelvy[supreg].
Samer Youssef owned and operated SMA Patient Care LLC (SMA), which
was both a retail pharmacy and engaged in the wholesale distribution of
prescription drugs. SMA and its customers were not healthcare entities
under 21 CFR 203.3(q). Youssef operated SMA with the assistance of
Houda Bazzi. As part of Youssef and Bazzi's business, they learned
about customers who wanted to purchase certain prescription drugs, and
they worked to acquire the prescription drugs and re-sell them at a
profit. Youssef and Bazzi, however, did not have access to several
prescription cancer drugs.
Dr. Aslam came to an agreement with Youssef and Bazzi to purchase
and acquire prescription cancer drugs for purposes of selling these
drugs to and through SMA and its customers. But as a healthcare entity,
it was unlawful for Dr. Aslam to buy and resell prescription cancer
drugs because he was only allowed to buy drugs to administer to his
patients. Thus, to obtain these prescription drugs from Distributor-1
for purposes of the illegal resale to SMA and its customers, Dr. Aslam
made or caused to be made numerous false and misleading statements
including that these drugs were to be purchased to treat patients
pursuant to a valid prescription and that they would be resold in
compliance with the law. Immediately after receiving the prescription
drugs, Dr. Aslam contacted Bazzi and Youssef, and they arranged to pick
up the drugs from Somerset for resale to their customers.
From 2019 to 2023, Dr. Aslam used his medical license and
arrangement with Distributor-1 to purchase more than 20 different
prescription cancer drugs that he resold to and through SMA, including
for example, Enhertu[supreg], Poteligeo[supreg], Tivdak[supreg], and
Trodelvy[supreg]. He did so without ensuring the drugs--many of which
required special handling or were infusion drugs--were shipped
properly. None of the prescription drugs were administered or intended
to be administered to treat patients as required by law and the
applicable contract terms with Distributor-1. Dr. Aslam profited from
his purchase and resale of illegally purchased prescription cancer
drugs by charging SMA more than he paid Distributor-1, sharing the
profit when SMA resold the drugs for more than he charged SMA for the
drugs, and receiving rebates and discounts from Distributor-1 based on
the amount of qualifying drugs he purchased. During this time period,
Dr. Aslam bought from Distributor-1 more than $16 million in
prescription drugs that he resold to SMA. Based on a comparison of
records showing how much Dr. Aslam paid Distributor-1 and how much SMA
paid Dr. Aslam and Somerset, Dr. Aslam received $2,601,568.47 in
proceeds from the sales.
As a result of this conviction, FDA sent Dr. Aslam, by certified
mail, on June 1, 2026, 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 Dr. Aslam was
convicted of a felony under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. The proposal informed
Dr. Aslam of the proposed debarment and offered him 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 request a hearing constituted a waiver of the opportunity for a
hearing and of any contentions concerning this action. Dr. Aslam
received the proposal and notice of opportunity for a hearing on June
9, 2026. Dr. Aslam failed to request a hearing within the timeframe
prescribed by regulation and has, therefore, waived his opportunity for
a hearing and waived any contentions concerning his debarment (21 CFR
part 12).
II. Findings and Order
Therefore, the Division of Field Enforcement Director, Office of
Inspections and Investigations, under section 306(a)(2)(B) of the FD&C
Act, under authority delegated to the Director, Division of
Enforcement, finds that Dr. Naveed Aslam 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, Dr. Aslam is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(B) and 306(c)(2)(A)(ii) of the FD&C Act.
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 Dr. Aslam 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. Aslam 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 application from Dr.
Aslam during his period of debarment, other than in connection with an
audit under section 306(c)(1)(B) of the FD&C Act. Note that, for
purposes of sections 306 and 307 of the FD&C Act, a ``drug product'' is
defined as a ``drug subject to regulation under section 505, 512, or
802 of this [FD&C] Act [(21 U.S.C. 355, 360b, 382)] or under section
351 of the Public Health Service Act [(42 U.S.C. 262)]'' (section
201(dd) of the FD&C Act (21 U.S.C. 321(dd))).
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19654 Filed 9-24-26; 8:45 am]
BILLING CODE 4164-01-P
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