[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Notices]
[Pages 4830-4832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

     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: 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 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 (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