[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41483-41486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16350]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0658]


Vithal K. Patel; 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) is denying a request 
for a hearing submitted by Vithal K. Patel (Mr. Patel) and issuing an 
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
debarring Mr. Patel for 1 year 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 Mr. Patel was convicted of 
conspiracy to commit a felony under Federal law for conduct relating to 
the regulation of drug products under the FD&C Act and that the type of 
conduct underlying the conviction undermined the process for the 
regulation of drugs. In determining the appropriateness and period of 
Mr. Patel's debarment, FDA considered the relevant factors listed in 
the FD&C Act. Mr. Patel has 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 August 2, 2021.

ADDRESSES: Any application for termination of debarment by Mr. Patel 
under section 306(d) of the FD&C Act (application) may be submitted as 
follows:

Electronic Submissions

    <bullet> 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.
    <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-
2011-N-0658. 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.
    <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 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

[[Page 41484]]

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)(II) of the FD&C Act (21 U.S.C. 
335a(b)(2)(B)(i)(II)) permits FDA to debar an individual if it finds: 
(1) That the individual has been convicted of a conspiracy to commit a 
felony under Federal law for conduct relating to the regulation of any 
drug product under the FD&C Act and (2) that the type of conduct 
serving as the basis of the conviction undermines the process for the 
regulation of drugs.
    On August 7, 2007, Mr. Patel pled guilty to a felony count of 
conspiracy to distribute misbranded and adulterated drugs in violation 
of 18 U.S.C. 371. On December 16, 2010, the U.S. District Court for the 
District of New Jersey entered the conviction, sentenced Mr. Patel to 2 
years of probation, and imposed a $3,000 fine. Mr. Patel's conviction 
stemmed from his employment at Able Laboratories, Inc. (Able), where he 
was a Research and Development Manager and later the Associate Director 
for Technical Service. Mr. Patel and others conspired to cause the 
introduction of misbranded and adulterated drugs into interstate 
commerce with the intent to defraud and mislead the United States, in 
violation of sections 301(a) and 303(a)(2) of the FD&C Act (21 U.S.C. 
331(a) and 333(a)(2)). According to the criminal information to which 
he pled guilty under a plea agreement, Mr. Patel and his coconspirators 
agreed to violate FDA's regulations regarding good manufacturing 
practice for drugs by, among other things, manipulating and falsifying 
testing data and information. Mr. Patel specifically admitted to an 
overt act in furtherance of the conspiracy, namely supervising the 
manipulation of the process for manufacturing promethazine, a 
prescription antihistamine medication.
    By letter dated January 6, 2012, FDA's Office of Regulatory Affairs 
(ORA) notified Mr. Patel of an opportunity for a hearing on a proposal 
to debar him for 5 years from providing services in any capacity to a 
person having an approved or pending drug product application. In its 
proposal, ORA concluded that Mr. Patel should be debarred for 5 years 
based on four applicable considerations in section 306(c)(3) of the 
FD&C Act: (1) The nature and seriousness of his offense, (2) the nature 
and extent of management participation in the offense, (3) the nature 
and extent of voluntary steps taken to mitigate the impact on the 
public, and (4) prior convictions involving matters within FDA's 
jurisdiction. ORA found that the first three of those considerations 
weigh in favor of debarment and noted, as to the fourth consideration, 
that FDA is unaware of any prior convictions.
    In a letter dated March 8, 2012, Mr. Patel requested a hearing on 
the proposal and submitted materials and arguments in support of his 
request. In his submission, Mr. Patel acknowledges his conviction of a 
conspiracy to commit a felony under Federal law and does not dispute 
that the conduct underlying that conviction related to the regulation 
of a drug product or that conduct of that type undermines the process 
for the regulation of drugs. He argues, however, that with respect to 
the considerations for determining the appropriateness and period of 
debarment under section 306(c)(3) of the FD&C Act, there are genuine 
and substantial issues of fact for resolution at a hearing.

II. Statutory and Regulatory Framework Regarding Part 12 Hearings

    Under the authority delegated by the Commissioner of Food and 
Drugs, the Chief Scientist has considered Mr. Patel's submission. Under 
Sec.  12.24(a)(2) (21 CFR 12.24(a)(2)), the Agency reviews a hearing 
request to determine whether a hearing is justified. FDA has the 
authority to deny a hearing when it appears from the hearing request 
that there are no material disputes of fact. See Costle v. Pacific 
Legal Found., 445 U.S. 198, 214 (1980) (a party seeking a hearing is 
required to meet a ``threshold burden of tendering evidence suggesting 
the need for a hearing''), reh'g denied, 446 U.S. 947 (1980), citing 
Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 620-21 
(1973); Pineapple Growers Ass'n v. FDA, 673 F.2d 1083, 1085-86 (9th 
Cir. 1982) (holding that no hearing is necessary unless ``material 
issues of fact'' have been raised).
    In determining whether there are material issues of fact suitable 
for a hearing, FDA considers the specific criteria set out in Sec.  
12.24(b) and grants a hearing only if the material submitted in support 
of the request shows the following: (1) There is a genuine and 
substantial factual issue for resolution at a hearing; a hearing will 
not be granted on issues of policy or law; (2) the factual issue can be 
resolved by available and specifically identified reliable evidence; a 
hearing will not be granted on the basis of mere allegations or denials 
or general descriptions of positions and contentions; (3) the data and 
information submitted, if established at a hearing, would be adequate 
to justify resolution of the factual issue in the way sought by the 
requestor; a hearing will be denied if the Agency concludes that the 
data and information submitted are insufficient to justify the factual 
determination urged, even if accurate; (4) resolution of the factual 
issue in the way sought by the person is adequate to justify the action 
requested; a hearing will not be granted on factual issues that are not 
determinative with respect to the action requested (e.g., if the Agency 
concludes that the action would be the same even if the factual issue 
were resolved in the way sought); (5) the action requested is not 
inconsistent with any provision in the FD&C Act or any FDA regulation; 
and (6) the requirements in other applicable regulations, e.g., 21 CFR 
10.20, 12.21, and 12.22, and in the notice of an opportunity for 
hearing are met.

III. Arguments

    In his request for a hearing, Mr. Patel challenges ORA's findings 
with respect to the three considerations that it concluded weighed in 
favor of his debarment. Mr. Patel also contends that there are two 
additional considerations under section 306(c)(3) of the FD&C Act that 
were not considered by ORA and should weigh in his favor against 
debarment. Section 306(c)(3) of the FD&C Act explicitly requires that 
FDA consider, ``where applicable,'' certain factors ``[i]n determining 
the appropriateness and the period of debarment'' for any permissive 
debarment.

A. Nature and Seriousness of the Offense

    Regarding the nature and seriousness of his offense, Mr. Patel 
contends that, in reaching its conclusion regarding the nature and 
seriousness of his felony

[[Page 41485]]

offense, ORA failed to consider certain important facts. Specifically, 
Mr. Patel argues that the overt act underlying his conspiracy 
conviction--namely supervising manipulation of the process for 
manufacturing promethazine--involved merely failing to document or 
follow proper procedures for a nitrogen flush and ``posed no danger to 
the end users, the public at large, or coworkers at Able.'' He reasons 
that, ``as an inert gas, nitrogen could not possibly interact with the 
[promethazine hydrochloride] in any way.'' Mr. Patel maintains that 
this factor should therefore not have weighed in favor of his 
debarment. However, as part of his guilty plea, Mr. Patel admitted to 
conspiring to cause the introduction of misbranded and adulterated 
products into interstate commerce, with the intent to defraud and 
mislead the United States. Therefore, even assuming that Mr. Patel did 
not intend for his conduct to harm anyone, the offense to which Mr. 
Patel pled guilty remains serious and weighs in favor of debarment.

B. Nature and Extent of Management Participation in the Offense

    As to the consideration addressing the nature and extent of 
management participation, Mr. Patel argues that ORA's analysis 
overlooks the nature and extent of Mr. Patel's management participation 
in the offense and reaches the conclusion that this factor is 
unfavorable ``simply because Mr. Patel was not an entry level worker.'' 
In fact, Mr. Patel insists that he ``never participated in the 
production of commercial products at Able Labs'' and, as such, 
``exercised no `management' authority in connection with the nitrogen 
flush'' and ``had no input into or control over Able Labs' `corporate 
policies and practices' or `institutional controls' with respect to 
production processes.'' To the contrary, Mr. Patel emphasizes that 
``both the United States Attorney's Office and [the court] confirmed 
that Mr. Patel was acting on the order of his superior managers to 
observe the nitrogen flush and was in fear the he would be terminated 
if he refused.''

    In the proposal to debar, ORA stated:
    As a Research and Development Manager and Associate Director of 
Technical Service, you were responsible for supervising numerous 
chemists and technicians who manufactured test batches to ensure 
product safety and effectiveness. Your management position also 
entailed monitoring the chemists' compliance with GMPs, as required 
by FDA, and SOPs established by the company and ensuring compliance 
with Able's SOPs, including protocols for investigating, logging, 
and archiving any aberrant, deviant, or failing analytical 
laboratory results. As supervisor, you held a position of authority 
in which your conduct served as an example to other employees. 
Accordingly, the Agency will consider this an unfavorable factor.

    Mr. Patel does not dispute that he was in a supervisory position at 
Able. Even assuming Mr. Patel reasonably feared termination related to 
the conspiracy he joined, Mr. Patel does not contest that he worked in 
a position of authority at Able and had the responsibilities outlined 
in ORA's proposal to debar him for 5 years. Therefore, Mr. Patel has 
failed to create an issue for hearing with respect to whether the 
nature and extent of his management participation in the offense should 
weigh against debarment.

C. Changes in Ownership, Management, or Operations

    Next, Mr. Patel argues that ORA incorrectly failed to consider 
``whether the extent to which changes in ownership, management, or 
operations have corrected the causes of any offense involved and 
provide reasonable assurances that the offense will not occur in the 
future,'' under section 306(c)(3)(D) of the FD&C Act. Mr. Patel states 
that an offense will not occur here in the future because ``Able Labs 
is now defunct'' and he ``voluntarily left the pharmaceutical industry 
in 2007.''
    FDA must consider, where applicable, ``whether the extent to which 
changes in ownership, management, or operations have corrected the 
causes of any offense involved and provide reasonable assurances that 
the offense will not occur in the future.'' The considerations in 
section 306(c)(3) of the FD&C Act are not only for individuals but also 
for corporations, partnerships, and associations subject to permissive 
debarment. This consideration does not typically apply to individuals 
because individuals are incapable of changes in ownership or management 
and could only alter the current operations of a business enterprise in 
which they are currently engaged. Even assuming for the sake of 
argument that an individual could point to changes in his or her 
current business practices as an applicable consideration under section 
306(c)(3) of the FD&C Act, Mr. Patel's contention that, because he 
voluntarily left the pharmaceutical industry he has provided reasonable 
assurances that he will not commit the offense again given the 
opportunity, fails to create a genuine and substantial issue of fact 
that warrants a hearing. Furthermore, given that this debarment 
proceeding focuses on Mr. Patel rather than Able, it is immaterial that 
Able Labs is no longer in business.

D. Abbreviated New Drug Applications (ANDAs)

    Mr. Patel argues that ``whether the person to be debarred is able 
to present adequate evidence that current production of drugs subject 
to abbreviated drug applications and all pending abbreviated drug 
applications are free of fraud or material false statements'' under 
section 306(c)(3)(E) of the FD&C Act should be considered in his favor 
because the improper manufacturing procedures for which Mr. Patel was 
convicted ``had no relation to a drug application in any way.'' This 
factor is only relevant for persons that have an ANDA. Mr. Patel has 
not presented any evidence that he has any existing abbreviated drug 
applications for consideration in his own name, and thus, this factor 
is not relevant in determining the appropriateness and length of 
debarment and fails to create a genuine and substantial issue of fact 
that warrants a hearing.

E. Nature and Extent of Voluntary Steps To Mitigate

    Lastly, under section 306(c)(3)(C) of the FD&C Act, in determining 
the appropriateness and period of debarment, FDA must consider, where 
applicable, ``the nature and extent of voluntary steps to mitigate the 
effect on the public,'' including whether the person took specified 
corrective actions after the criminal violation or fully cooperated 
with any investigations. In the proposal to debar, ORA concluded that 
Mr. Patel's ``failure to take voluntary steps to mitigate the offense 
[he] committed'' rendered this an unfavorable factor. ORA based this 
conclusion on the fact that ``FDA has no information demonstrating that 
[Mr. Patel] took any voluntary steps to mitigate the impact of [his] 
actions on the public.''
    In his hearing request, Mr. Patel maintains that he did, in fact, 
take voluntary steps to mitigate the effect of his offense on the 
public, including ``full cooperation with any investigations'' under 
section 306(c)(3)(C) of the FD&C Act. In support, Mr. Patel submits a 
letter from an Assistant U.S. Attorney who participated in his 
prosecution and a transcript of his sentencing. Quoting this letter, 
Mr. Patel maintains that his cooperation enabled the Government to 
``expand its investigation to other individuals and to develop a better 
understanding of the misbranding conspiracy at Able Labs'' and 
``permitted the government to vet the information . . . received from 
other

[[Page 41486]]

individuals and to follow new leads.'' Furthermore, he adds that he 
provided valuable ``details about events and discussions demonstrating 
that Able Labs' management had made changes to drug protocols.'' He 
relies on these submissions to demonstrate not only that he cooperated 
with the government and contributed to the successful prosecution of 
others, including Able's top manager, but also that the government 
argued at his sentencing that he provided ``substantial assistance'' in 
those investigations and moved for a more lenient sentence on that 
basis. Mr. Patel's account of his cooperation and substantial 
assistance in the investigation is undisputed and supported by the 
transcript of his sentencing. Therefore, the nature and extent of the 
voluntary steps Mr. Patel took to mitigate the impact of his offense on 
the public under section 306(c)(3)(C) of the FD&C Act weigh in Mr. 
Patel's favor in determining the appropriateness and period of 
debarment.
    Given the undisputed facts described above, and after considering 
the applicable factors listed in section 306(c)(3) of the FD&C Act, the 
Chief Scientist finds that Mr. Patel's conviction warrants a 1-year 
debarment period. It is undisputed that Mr. Patel pled guilty to a 
serious offense and that he participated in the offense as a 
supervisor. However, Mr. Patel took significant steps to mitigate the 
effect of his offense on the public, as described in the Assistant U.S. 
Attorney's letter, and he has no prior convictions. Particularly in 
light of FDA's strong public policy interest in encouraging cooperation 
with authorities engaged in investigating wrongdoing related to the 
Agency's regulation of drugs, as reflected in section 306(c)(3)(C) of 
the FD&C Act, the Chief Scientist has determined that a debarment 
period of only 1 year is appropriate in this case.

IV. Findings and Order

    Therefore, the Chief Scientist, under section 306(b)(2)(B)(i)(II) 
of the FD&C Act and under authority delegated to her by the 
Commissioner of Food and Drugs, finds that: (1) Mr. Patel has been 
convicted of a conspiracy to commit a felony under Federal law for 
conduct relating to the regulation of a drug product under the FD&C Act 
and (2) that the conduct which served as the basis for the conviction 
undermines the process for the regulation of drugs. FDA has considered 
the applicable factors listed in section 306(c)(3) of the FD&C Act and 
determined that a debarment of 1 year is appropriate.
    As a result of the foregoing findings, Mr. Patel is debarred for 1 
year 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 August 
2, 2021 (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 product 
application, who knowingly uses the services of Mr. Patel, in any 
capacity during his period of 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 Mr. Patel, 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 Mr. Patel during his period of debarment (section 
306(c)(1)(B) of the FD&C Act).

    Dated: July 27, 2021.
Denise Hinton,
Chief Scientist.
[FR Doc. 2021-16350 Filed 7-30-21; 8:45 am]
BILLING CODE 4164-01-P