Notice2021-16350
Vithal K. Patel; Denial of Hearing; Final Debarment Order
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Published
August 2, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 145 (Monday, August 2, 2021)</title>
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[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41483-41486]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <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-
2011-N-0658. 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
[[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: <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)(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
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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
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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
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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.