Notice2023-02161
Sami Anwar; Denial of Hearing; Final Debarment Order
Primary source
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Published
February 2, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is denying a request for a hearing submitted by Sami Anwar (Anwar) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Anwar from providing services in any capacity to a person having an approved or pending drug product application. FDA bases this order on a finding that Anwar was convicted of felonies under Federal law for conduct relating to the development or approval of any drug product or otherwise relating to the regulation of a drug product under the FD&C Act. Anwar failed to file with the Agency information and analysis sufficient to create a basis for a hearing concerning this action.
Full Text
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<title>Federal Register, Volume 88 Issue 22 (Thursday, February 2, 2023)</title>
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[Federal Register Volume 88, Number 22 (Thursday, February 2, 2023)]
[Notices]
[Pages 7093-7094]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-02161]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2109]
Sami Anwar; 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 the Agency) is
denying a request for a hearing submitted by Sami Anwar (Anwar) and is
issuing an order under the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) permanently debarring Anwar from providing services in any
capacity to a person having an approved or pending drug product
application. FDA bases this order on a finding that Anwar was convicted
of felonies under Federal law for conduct relating to the development
or approval of any drug product or otherwise relating to the regulation
of a drug product under the FD&C Act. Anwar failed to file with the
Agency information and analysis sufficient to create a basis for a
hearing concerning this action.
DATES: The order is applicable February 2, 2023.
ADDRESSES: Any application for special termination of debarment by
Anwar 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 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: Your application must include the Docket No. FDA-
2020-N-2109. 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(a)(2) of the FD&C Act (21 U.S.C. 335a(a)(2)) mandates
permanent debarment if FDA finds that the individual has been convicted
of a felony under Federal law for conduct relating to the development
or approval, including the process for development or approval, of any
drug product or otherwise relating to the regulation of any drug
product under the FD&C Act.
On October 1, 2020, the U.S. District Court for the Eastern
District of Washington entered a judgment against Anwar, after a jury
verdict, for 24 counts of wire fraud in violation of 18 U.S.C. 1349, 15
counts of mail fraud in violation of 18 U.S.C. 1341, 1 count of
conspiracy to commit mail fraud in violation of 18 U.S.C. 371, 6 counts
of fraudulently obtaining controlled substances in violation of 21
U.S.C. 843(a)(3), and 1 count of furnishing false or fraudulent
material information to
[[Page 7094]]
the Drug Enforcement Administration in violation of 21 U.S.C.
843(a)(4)(A). As described below, the basis of Anwar's convictions
stems from Anwar and his companies' falsifying research data for human
clinical trials, including forging and falsifying documents to make it
appear as though such clinical trials were performed and supervised by
a qualified and licensed physician and falsifying medical records and
data to admit dozens of ineligible subjects into the clinical trials.
By letter dated January 6, 2021, FDA's Office of Regulatory Affairs
(ORA) notified Anwar of a proposal to permanently debar him from
providing services in any capacity to a person that has an approved or
pending drug product application and provided him an opportunity to
request a hearing. As explained in the notice, the basis for the
proposed debarment is Anwar's felony convictions in the U.S. District
Court for the Eastern District of Washington. According to ORA, Anwar
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 felonies
under Federal law for conduct relating to the development or approval
of any drug product or otherwise relating to the regulation of a drug
product under the FD&C Act.
The proposal to debar states that the convictions relate to Anwar's
role as owner and operator of Mid-Columbia Research LLC and Zain
Research LLC, contract research organizations that oversaw and
conducted clinical research trials on a contract basis for various drug
sponsors. As described in the proposal, Anwar directed and carried out
a conspiracy to have his companies fraudulently pose as legitimate
human clinical research trial sites, and Anwar provided false clinical
research trial data regarding drug safety and drug efficacy to dozens
of drug companies and, through them, FDA, which regulates human
clinical trials in the United States. Anwar also posed as a doctor and
forged the signatures of the doctors he employed. In addition, Anwar
directed his employees to assist in committing the fraud, including:
(1) falsifying medical records and data to admit dozens of ineligible
research subjects, (2) falsifying research data vital signs, (3)
stealing blood samples taken from patients without their knowledge or
consent, (4) directing patients to dispose of study medications and
then falsely record dispensing as required by the study, (5)
fraudulently obtaining and acquiring opioids intended to be dispensed
to study subjects, and (6) falsifying subject diaries. In the proposal
to debar, ORA found that Anwar's convictions, and underlying conduct,
relate to the process for development or approval, including the
process for development or approval, of any drug product and for
conduct relating to the regulation of any drug product under the FD&C
Act.
In a letter dated January 22, 2021, Anwar submitted a ``request for
an extension of the hearing.'' This letter did not contain a request
for a hearing, but the Director of the Office of Scientific Integrity,
who has the authority to rule upon debarment matters, construed it as
one. In addition, Anwar was given an extension to submit any
information or factual analyses in support of his request for a hearing
until April 15, 2021. Anwar has not filed any additional information to
support his request.
Under the authority delegated to her by the Commissioner of Food
and Drugs, the Chief Scientist has considered Anwar's request for a
hearing. Hearings are granted only if there is a genuine and
substantial issue of fact. 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)).
Since Anwar has not presented any information to support his
hearing request, the Chief Scientist concludes that Anwar failed to
raise a genuine and substantial issue of fact requiring a hearing.
Therefore, the Chief Scientist denies Anwar's request for a hearing.
II. Findings and Order
The Chief Scientist, under section 306(a)(2) of the FD&C Act and
under the authority delegated to her, finds that Sami Anwar has been
convicted of felonies under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of any drug product or otherwise relating to the regulation
of a drug product under the FD&C Act.
As a result of the foregoing findings, Sami Anwar 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 Anwar, 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 Anwar, 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 Anwar
during his period of debarment.
Dated: January 27, 2023.
Namandj[eacute] N. Bumpus,
Chief Scientist.
[FR Doc. 2023-02161 Filed 2-1-23; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on February 2, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.