[Federal Register Volume 88, Number 26 (Wednesday, February 8, 2023)]
[Notices]
[Pages 8292-8295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02634]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1996]


Hassan Tahsildar; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
denying Hassan Tahsildar's (Dr. Tahsildar's) request for a hearing and 
issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) debarring Dr. Tahsildar for 2 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. Tahsildar was 
convicted of a misdemeanor under Federal law for causing the 
introduction or delivery for introduction of misbranded drugs into 
interstate commerce. Additionally, FDA finds that the conduct 
underlying Dr. Tahsildar's conviction related to the regulation of 
drugs under the FD&C Act and that the type of conduct underlying his 
conviction undermines the process for the regulation of drugs. In 
determining the appropriateness and period of Dr. Tahsildar's 
debarment, FDA considered the relevant factors listed in the FD&C Act 
and concluded that a hearing is unnecessary.

DATES: This order is applicable February 8, 2023.

ADDRESSES: Any application for termination of debarment by Dr. 
Tahsildar under section 306(d) of the FD&C Act (21 U.S.C. 335a(d)) 
(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.

[[Page 8293]]

     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-1996. Received applications will be placed in the docket and, 
except for those 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(b)(2)(B)(i)(I) of the FD&C Act 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 type of conduct 
underlying the conviction undermines the process for the regulation of 
drugs.
    On September 30, 2013, Dr. Tahsildar pled guilty to a misdemeanor 
for introducing, or causing the introduction of, a misbranded drug into 
interstate commerce, in violation of section 301(a) of the FD&C Act (21 
U.S.C. 331(a)). According to the criminal information to which Dr. 
Tahsildar pled guilty, between January 10, 2006, and March 12, 2009, 
Dr. Tahsildar ``purchased and received'' prescription oncology drugs 
from Canada. In pleading guilty, Dr. Tahsildar's admitted that his 
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. On January 28, 2014, the U.S. District Court for the Northern 
District of Ohio entered a judgment of conviction against Dr. Tahsildar 
for his violation of section 301(a) of the FD&C Act and sentenced him 
to 1 year of probation.
    By letter dated July 13, 2018, FDA's Office of Regulatory Affairs 
(ORA) proposed to debar Dr. Tahsildar 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 ORA based the 
proposed debarment on his misdemeanor conviction and concluded that a 
3-year debarment is appropriate.
    By letter dated September 10, 2018, Dr. Tahsildar, through counsel, 
requested a hearing on the proposal. Dr. Tahsildar argues that there 
are genuine and substantial issues of fact that support his request for 
a hearing. He contends that, in contrast to the findings in ORA's 
proposal to debar him, he did not receive notices from FDA that certain 
drugs being shipped from Canada to the medical practice in which he was 
a partner had been detained on the ground that they appeared to be 
unapproved drugs. He also asserts that he was never involved in the 
management or daily operations of the medical practice in which he was 
a ``junior partner,'' including contracting with drug suppliers or 
ordering drugs for use in the practice.
    Under the authority delegated to her by the Commissioner of Food 
and Drugs, the Chief Scientist has considered Dr. Tahsildar'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)).
    The Chief Scientist has considered Dr. Tahsildar's arguments, as 
well as the proposal to debar, and concludes that there is no genuine 
and substantial issue of fact requiring a hearing.

II. Arguments

    In response to the proposal to debar, Dr. Tahsildar does not appear 
to challenge that he is subject to debarment under section 306(b)(2)(B) 
of the FD&C Act. Instead, Dr. Tahsildar disputes the factual basis for 
ORA's findings with respect to the considerations under section 
306(c)(3) of the FD&C Act. ORA's proposal outlined findings concerning 
the four factors that ORA considered in determining the appropriateness 
and period of debarment: (1) the nature and seriousness of the offense, 
(2) the nature and extent of management participation in the offense, 
(3) the nature and extent of voluntary steps to mitigate the impact on 
the public, and (4) prior convictions under the FD&C Act or other acts 
involving matters within FDA's jurisdiction. ORA found that the first 
two factors were unfavorable factors and that the latter two factors 
were favorable for Dr. Tahsildar. The proposal concluded that the 
unfavorable factors outweigh the favorable factors and that a 3-year 
debarment is thus appropriate.
    With respect to the nature and seriousness of his offense under 
section 306(c)(3)(A) of the FD&C Act, ORA found in the proposal that 
the conduct underlying Dr. Tahsildar's misdemeanor conviction included 
``purchasing and receiving numerous units of unapproved oncology drugs 
. . . from a Canadian distributor.'' ORA further found that Dr. 
Tahsildar ``continued purchasing these drugs despite being notified by 
FDA on multiple occasions that foreign drug shipments destined for 
[his] office had been detained and appeared to be unlawfully marketed 
unapproved new drugs.'' Relying on those factual findings, ORA 
determined that his conduct ``created a risk of injury to consumers'' 
and ``undermined the

[[Page 8294]]

Agency's drug approval process and the Agency's oversight of the 
manufacture, importation, and sale of drug products in interstate 
commerce in the United States.''
    In support of his hearing request, Dr. Tahsildar maintains not only 
that he had ``no intention of violating the law'' but also that ``he 
had no prior knowledge that any of the medications coming into his 
practice were imported from Canada.'' He explains that he first learned 
that the practice's Texas supplier had been ``shipping Canadian drugs 
to the practice'' when two agents from FDA visited the practice and 
provided that information to him, at which point the practice severed 
its relationship with the Texas supplier and ``never received 
medications from Canada or the Texas supplier again.'' Indeed, he 
specifically challenges as inaccurate ORA's finding that ``he continued 
purchasing [the] drugs despite being notified by FDA on multiple 
occasions that foreign drug shipments destined for [his] office had 
been detained and appeared to be unlawfully marketed unapproved new 
drugs'' :

    Please note that there is an inaccuracy in [ORA's proposal.] Dr. 
Tahsildar did not continue to purchase the Canadian drugs and was 
not notified by the FDA on multiple occasions that foreign drug 
shipments destined for his office had been detained and appeared to 
be unlawfully marketed unapproved new drugs. I believe [ORA is] 
referring to the four notices from the FDA with status dates of May 
2, June 27, October 21, and November 17, 2008. All such notices were 
addressed to [his partner] and were not brought to Dr. Tahsildar's 
attention until after the two FDA agents came to the office in 2009.

    He further points to the findings of the State Medical Board of 
Ohio in support of these assertions. As quoted by Dr. Tahsildar, the 
State Medical Board determined that ``[r]eprints of FDA detainer 
notices . . . clearly show that they had been addressed to'' his 
partner.
    Insofar as Dr. Tahsildar argues that he did not intend to violate 
the FD&C Act, he has not raised a genuine and substantial issue of fact 
with respect to the nature and seriousness of his misdemeanor offense. 
A misdemeanor violation of the FD&C Act itself is a strict liability 
offense under section 303(a)(1) of the FD&C Act (21 U.S.C. 333(a)(1)) 
and requires no showing of any criminal intent, and his mere assertion 
that he lacked any intent to violate the law is of no moment 
whatsoever. On the other hand, the Chief Scientist need not address 
whether Dr. Tahsildar's factual challenges to ORA's key finding that he 
continued to order the oncology drugs at issue after FDA provided him 
notice that they were unapproved and thus violated the FD&C Act raise a 
genuine and substantial issue of fact with respect to that finding 
because the Chief Scientist will assume for purposes of determining the 
appropriateness and period of his debarment that he received no such 
notice and that the medical practice discontinued ordering such drugs 
after he learned they were unapproved.
    With respect to ORA's findings as to the nature and seriousness of 
his offense under section 306(c)(3)(A) of the FD&C Act, Dr. Tahsildar 
also challenges ORA's finding that the conduct underlying his 
misdemeanor offense ``created a risk of injury to consumers.'' Dr. 
Tahsildar contends that Federal prosecutors ``made no allegations 
whatsoever that [he] engaged in any conduct that put his patients at 
risk'' and that ``the FDA agents [who visited the practice] told him 
that the FDA was not concerned that drugs at issue were inferior'' and 
that the practice could continue using the drugs. This factual 
challenge does not raise a genuine and substantial issue of fact. 
Violating the FD&C Act in a manner that results in administering 
unapproved drugs to patients creates an inherent risk to those 
patients, notwithstanding any alleged statements to the contrary by FDA 
agents or the failure of Federal prosecutors to rely on those facts as 
part of the criminal prosecution.
    Dr. Tahsildar next challenges ORA's findings regarding nature and 
extent of his management participation under section 306(c)(3)(B) of 
the FD&C Act. In its proposal, ORA stated that, as a licensed 
physician, Dr. Tahsildar ``held a position of authority in [his] 
medical practice where [his] conduct served as an example for his 
employees.'' ORA found that his conduct was more serious than if he 
were a mere employee and found this factor to be unfavorable for Dr. 
Tahsildar.
    In response to these findings, Dr. Tahsildar states that ``he was 
never involved in the management or daily operations of the practice, 
including contracting with medication suppliers or ordering any 
medications'' :

    When [he] was hired by [the senior partner] in 1995, he was a 
first-time practicing physician, coming directly out of fellowship. 
In 1998, Dr. Tahsildar became a junior partner of [the] practice. 
[The senior partner] retained a 51% ownership interest in the 
practice, and Dr. Tahsildar purchased a 49% ownership interest. [The 
senior partner] remained in control of the management and day-to-day 
operations of the practice, giving no control to Dr. Tahsildar. This 
[arrangement], however, worked well for Dr. Tahsildar because he had 
wanted to remain a clinician only and had been happy to leave the 
management and financial aspects of the practice to [the senior 
partner], who in turn received a three[-]percent management fee for 
doing so. Dr. Tahsildar received no such management fee.

    Dr. Tahsildar further contends that he ``did not negotiate or sign 
contracts on behalf of the practice (including any medication supplier 
contracts), nor did he sign checks on behalf of the practice, with the 
exception of one occasion.'' He also maintains that he was never 
involved in ordering any drugs for the medical practice. Dr. Tahsildar 
argues, therefore, that the Agency should consider his management 
participation in the offense under section 306(c)(3)(B) of the FD&C Act 
as a favorable factor.
    As a preliminary matter, the Chief Scientist notes that Dr. 
Tahsildar admitted during the criminal proceedings against him that he 
``purchased and received'' the oncology drugs at issue when he pled 
guilty pursuant to a criminal information charging him with that 
conduct. His assertions to the contrary do not raise a genuine and 
substantial issue of fact. Nevertheless, his contentions regarding his 
role in the practice, though not in direct conflict with the findings 
in ORA's proposal, do provide additional factual context for ORA's 
findings and thus warrant consideration under section 306(c)(3)(B) of 
the FD&C Act. However, notwithstanding Dr. Tahsildar's claims that he 
did not take an active role in managing the practice, including 
ordering drug products, it is undisputed that Dr. Tahsildar was in a 
position of authority in the practice, even if he was not the 
managerial equal to the senior partner. By his own admission, Dr. 
Tahsildar was one of two partners in a medical practice, and he failed 
to ensure that his patients were receiving FDA-approved drugs. The 
Chief Scientist will nonetheless account for Dr. Tahsildar's provision 
of additional factual context regarding his role in the practice in 
assessing the consideration under section under 306(c)(3)(B) of the 
FD&C Act in determining the appropriateness and period of his 
debarment, as discussed below.
    Considering all the applicable factors listed in section 306(c)(3) 
of the FD&C Act, the Chief Scientist finds that Dr. Tahsildar's 
misdemeanor offense and underlying conduct warrant a 2-year debarment 
period, as opposed to the 3-year period of debarment proposed by ORA. 
Although the Chief Scientist has assumed that Dr. Tahsildar had no 
prior

[[Page 8295]]

notice that the oncology drugs at issue were unapproved and that the 
medical practice discontinued ordering those drugs when he learned of 
that regulatory status, as discussed above, it is undisputed that the 
offense to which he pled guilty led to his administering foreign, 
unapproved drug products to his patients. Even assuming Dr. Tahsildar's 
representations with respect to his reduced role as a manager in the 
practice to be true, the Chief Scientist also cannot conclude that his 
managerial role is a favorable consideration, given his status as a 
partner and a physician in that practice. Balancing the applicable 
considerations--including his voluntary steps in mitigation under 
section 306(c)(3)(C) of the FD&C Act and the absence of previous 
criminal convictions related to matters within the jurisdiction of FDA 
under section 306(c)(3)(F)--the Chief Scientist has determined that a 
2-year debarment period is appropriate. Inasmuch as there are no 
material factual disputes for resolution at a hearing, the Chief 
Scientist is also denying Dr. Tahsildar's hearing request.
    Separately, Dr. Tahsildar requests that, in lieu of debarment by 
FDA, he enter into a settlement agreement with FDA whereby he would 
voluntarily agree to the terms of the proposed debarment for the 
proposed period of debarment and to not provide services in any 
capacity to a person that has an approved or pending drug product 
application. Dr. Tahsildar appears to be proposing an informal 
resolution of this debarment matter. However, his request is now moot 
given that the foregoing findings support debarment for a 2-year 
period.

III. Findings and Order

    Therefore, the Chief Scientist, under section 306(b)(2)(B)(i)(I) of 
the FD&C Act and authority delegated to her by the Commissioner of Food 
and Drugs, finds that Dr. Tahsildar has been convicted of a misdemeanor 
under Federal law for conduct related to the regulation of drugs under 
the FD&C Act and that the type of conduct underlying the conviction 
undermines the regulation of drugs. FDA has considered the relevant 
factors listed in section 306(c)(3) of the FD&C Act and determined that 
a 2-year debarment is appropriate.
    As a result of the foregoing findings, Dr. Tahsildar is debarred 
for 2 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 
February 8, 2023, (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. Tahsildar, 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. 
Tahsildar, 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. Tahsildar during his period of debarment (section 
306(c)(1)(B) of the FD&C Act).

    Dated: February 2, 2023.
Namandj[eacute] N. Bumpus,
Chief Scientist.
[FR Doc. 2023-02634 Filed 2-7-23; 8:45 am]
BILLING CODE 4164-01-P