Notice2023-02634
Hassan Tahsildar; Denial of Hearing; Final Debarment Order
Primary source
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Published
February 8, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 26 (Wednesday, February 8, 2023)</title>
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[Federal Register Volume 88, Number 26 (Wednesday, February 8, 2023)]
[Notices]
[Pages 8292-8295]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-02634]
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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.
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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
<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.
[[Page 8293]]
<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-1996. 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 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 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
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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
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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
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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.