[Federal Register Volume 88, Number 22 (Thursday, February 2, 2023)]
[Notices]
[Pages 7093-7094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

     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-
2020-N-2109. 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.
     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(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


