Notice2023-01419
Poornanand Palaparty; Denial of Hearing; Final Debarment Order
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Published
January 25, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is denying Poornanand Palaparty's (Dr. Palaparty's) request for a hearing and issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. Palaparty for 3 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. Palaparty was convicted of a misdemeanor under Federal law for causing the introduction or delivery for introduction into interstate commerce of drugs that were misbranded under the FD&C Act. Additionally, FDA finds that the type of conduct underlying Dr. Palaparty's conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Dr. Palaparty's debarment, FDA considered the relevant factors listed in the FD&C Act. Dr. Palaparty failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Full Text
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<title>Federal Register, Volume 88 Issue 16 (Wednesday, January 25, 2023)</title>
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[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Notices]
[Pages 4830-4832]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-01419]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1988]
Poornanand Palaparty; 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, Agency, or we) is
denying Poornanand Palaparty's (Dr. Palaparty's) request for a hearing
and issuing an order under the Federal Food, Drug, and Cosmetic Act
(FD&C Act) debarring Dr. Palaparty for 3 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.
Palaparty was convicted of a misdemeanor under Federal law for causing
the introduction or delivery for introduction into interstate commerce
of drugs that were misbranded under the FD&C Act. Additionally, FDA
finds that the type of conduct underlying Dr. Palaparty's conviction
undermines the process for the regulation of drugs. In determining the
appropriateness and period of Dr. Palaparty's debarment, FDA considered
the relevant factors listed in the FD&C Act. Dr. Palaparty failed to
file with the Agency information and analyses sufficient to create a
basis for a hearing concerning this action.
DATES: This order is applicable January 25, 2023.
ADDRESSES: Any application for termination of debarment by Dr.
Palaparty 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: All applications must include the Docket No. FDA-
2018-N-1988. 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 (21 U.S.C.
335a(b)(2)(B)(i)(I)) 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
[[Page 4831]]
FD&C Act and (2) the type of conduct underlying the conviction
undermines the process for the regulation of drugs under the FD&C Act.
On September 5, 2013, Dr. Palaparty pled guilty to a misdemeanor
for introducing 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. Palaparty pled
guilty, between July 4, 2004, and February 26, 2009, Dr. Palaparty, an
oncologist, purchased and received prescription oncology drugs from a
distributer located in Canada. Dr. Palaparty's 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 November
12, 2014, the U.S. District Court for the Northern District of Ohio
entered a judgment of conviction against Dr. Palaparty for his
violation of section 301(a) and sentenced him to 1 year of probation.
By letter dated July 13, 2018, FDA's Office of Regulatory Affairs
(ORA) proposed to debar him for 3 years from providing services in any
capacity to a person that has an approved or pending drug product
application and provided him with an opportunity to request a hearing.
The proposal explained that FDA based the proposed debarment on his
misdemeanor conviction. The proposal outlined findings concerning the
four relevant factors that ORA considered in determining the
appropriateness and period of debarment, as provided in section
306(c)(3) of the FD&C Act: (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 the last two
factors were favorable for Dr. Palaparty. The notice concluded that the
unfavorable factors outweighed the favorable factors and that a 3-year
debarment was appropriate.
By letters dated August 10, 2018, and September 10, 2018, Dr.
Palaparty, through counsel, requested a hearing on the proposal. Dr.
Palaparty argues that FDA failed to consider certain facts underlying
his conviction and therefore inappropriately weighed the factors under
section 306(c)(3) of the FD&C Act. Dr. Palaparty primarily disputes
ORA's assessment of the nature and seriousness of his offense.
Separately, Dr. Palaparty requests that FDA consider a settlement
between the Agency and himself as an alternative to debarment.
Under the authority delegated to her by the Commissioner of Food
and Drugs, the Chief Scientist has considered Dr. Palaparty'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 Sec. 12.24(b) (21 CFR
12.24(b))).
Based on this review, the Chief Scientist concludes that Dr.
Palaparty has failed to raise a genuine and substantial issue of fact
requiring a hearing and that he has thus not justified a hearing. Given
the undisputed factual findings in the proposal to debar, the Chief
Scientist finds that a 3-year debarment period is appropriate.
II. Arguments
In the proposal to debar, ORA relied on the criminal information
and the Government's sentencing memorandum in addressing the nature and
seriousness of the offense. ORA noted that Dr. Palaparty ``continued
purchasing misbranded drugs despite being notified by FDA on multiple
occasions between 2004 and 2009 that foreign drug shipments destined
for [his] office had been detained and appeared to be unlawfully
marketed unapproved new drugs.'' ORA found that his ``conduct created a
risk of injury to consumers by exposing patients to unapproved new
drugs'' and that his conduct undermined the Agency's drug approval
process and oversight of the manufacture, importation, and sale of drug
products in interstate commerce in the United States.
In his request for a hearing, Dr. Palaparty disagrees with ORA's
assertion that his conduct created a risk of injury to consumers by
exposing patients to unapproved new drugs. Dr. Palaparty claims that
Agency investigators ``told him that he could use the rest of the
unapproved drugs as long as he did not order more of them.'' Dr.
Palaparty suggests that ``[i]f these drugs truly posed a great risk to
the public, the investigators would have instructed him to destroy the
remaining drugs and would not have allowed him to use his remaining
supply.''
Even if we assume what Dr. Palaparty asserts is true--that, on a
given day in 2009, FDA agents told Dr. Palaparty he could use up the
limited stock of unapproved new drugs he had in his office, instead of
destroying the drugs--this alone would not establish that his overall
pattern of conduct posed no risk to his patients and thus the public.
Instead, his overall pattern of conduct over a 5-year period
establishes that Dr. Palaparty willingly created a risk of injury to
his patients. Dr. Palaparty does not dispute that, between 2004 and
2009, he placed multiple orders for unapproved oncology drugs,
including Kytril, Gemzar, Oxaliplatin, Irinotecan, Camptosar, Zometa,
Gemcitabine, Campto, Zoledronic Acid, and Carboplatin, manufactured
outside of the United States. Additionally, Dr. Palaparty does not
dispute that he continued purchasing these misbranded drugs despite
being notified by FDA, on multiple occasions between 2004 and 2007,
that these foreign drug shipments destined for his office had been
detained and appeared to be unlawfully marketed unapproved new drugs.
These undisputed facts, combined with the record underlying Dr.
Palaparty's guilty plea, provide an ample basis for ORA to conclude
that Dr. Palaparty should be debarred and that the ``nature and
seriousness of [his] . . . offense'' is a factor that should be weighed
against him in determining the length of his debarment.
Under Sec. 12.24(b)(3), FDA will deny a hearing if ``the data and
information submitted are insufficient to justify the factual
determination urged, even if accurate.'' Applying this standard, Dr.
Palaparty has offered allegations that, even if true, are insufficient
to justify the larger factual determination he seeks: namely, that the
larger pattern of his conduct posed no risk to his patients and the
public and thus, by extension, did not interfere with FDA's ability to
oversee the manufacture, importation, and sale of drug products in
interstate commerce. Therefore, Dr. Palaparty fails to create an issue
for hearing with respect to whether the nature and seriousness of the
offense is an unfavorable factor in determining the appropriateness and
length of debarment.
Dr. Palaparty does not object to the rest of ORA's findings in the
proposal to debar. Regarding the nature and extent of management
participation in the offense, Dr. Palaparty concedes that he held a
position of authority in his medical practice as a licensed physician.
Dr. Palaparty's admission to his position of authority warrants
treating the management participation factor as an unfavorable factor
in determining the appropriateness and
[[Page 4832]]
length of debarment. With respect to the third and fourth factors, he
supports the findings that he mitigated the impact of his offenses on
the public by fully cooperating with investigators and that he had no
convictions involving matters within the jurisdiction of FDA.
Considering all the applicable factors listed in section 306(c)(3)
of the FD&C Act, the Chief Scientist finds that Dr. Palaparty's
conviction and underlying conduct warrant the 3-year debarment proposed
by ORA. It is undisputed that Dr. Palaparty pled guilty to a serious
misdemeanor offense by causing the introduction into interstate
commerce of drugs that were misbranded by virtue of their unapproved
status. It is undisputed that Dr. Palaparty had a managerial role,
further cementing the serious nature of Dr. Palaparty's conduct. While
Dr. Palaparty ultimately took voluntary steps to mitigate the effect on
the public health from the unlawful conduct and does not have any
previous criminal convictions related to matters within FDA's
jurisdiction, those considerations do not outweigh the nature and
seriousness of the conduct to a degree that would warrant a debarment
period of less than 3 years. Therefore, a 3-year debarment is
appropriate.
Separately, Dr. Palaparty 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. Palaparty appears to be proposing an informal
resolution of this debarment matter. However, his request is now moot,
given the foregoing findings, which establish that Dr. Palaparty has
failed to justify a hearing with respect to ORA's proposal to debar him
for 3 years, and support his debarment for the proposed time.
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. Palaparty has been convicted of a misdemeanor
under Federal law for causing the introduction into interstate commerce
of prescription drugs that were misbranded under the FD&C Act and that
the conduct underlying the conviction undermines the process for the
regulation of drugs. FDA considered the relevant factors listed in
section 306(c)(3) of the FD&C Act and determined that a 3-year
debarment is appropriate.
As a result of the foregoing findings, Dr. Palaparty is debarred
for 3 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 January
25, 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. Palaparty, 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. Palaparty,
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. Palaparty
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
Dated: January 19, 2023.
Namandje N. Bumpus,
Chief Scientist.
[FR Doc. 2023-01419 Filed 1-24-23; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on January 25, 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.