[Federal Register Volume 83, Number 247 (Thursday, December 27, 2018)]
[Notices]
[Pages 66717-66718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27951]


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 DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1989]


Ranjan Bhandari: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
debarring Ranjan Bhandari, MD (Dr. Bhandari), for a period of 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. Bhandari was convicted of a misdemeanor under the FD&C 
Act for causing the introduction or delivery for introduction into 
interstate commerce of prescription drugs that were misbranded. In 
addition, FDA has determined that the type of conduct that served as 
the basis for the conviction undermines the process for the regulation 
of drugs. Dr. Bhandari was given notice of the proposed debarment and 
an opportunity to request a hearing within the timeframe prescribed by 
regulation. Dr. Bhandari failed to request a hearing. Dr. Bhandari's 
failure to request a hearing constitutes a waiver of his right to a 
hearing concerning this action.

DATES: This order is effective December 27, 2018.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade (ELEM-4144), Division of 
Enforcement, Food and Drug Administration, 12420 Parklawn Dr., 
Rockville, MD 20857, 301-796-4640.

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 debarment of an individual if FDA finds 
that 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 if FDA finds that the type of conduct that served as the 
basis for the conviction undermines the process for the regulation of 
drugs.
    On December 9, 2013, in the U.S. District Court for the Northern 
District of Ohio, judgment was entered against Dr. Bhandari after he 
entered a plea of guilty to one count of misbranding in violation of 
section 301(a) of the FD&C Act (21 U.S.C. 331(a)), which is a 
misdemeanor offense under section 303(a)(1) of the FD&C Act (21 U.S.C. 
333(a)(1)). FDA's finding that debarment is appropriate is based on the 
misdemeanor conviction referenced herein. The factual basis for this 
conviction is as follows: Between June 1, 2006, and March 31, 2008, Dr. 
Bhandari was a physician (oncologist) in Ohio. During this time, Dr. 
Bhandari purchased and received oncology drugs, including ZOMETA, 
IRINOTECAN, ELOXATIN, GEMZAR, HYCAMTIN, ARANESP, and TAXOTERE, from a 
drug distributor located in Canada. These new drugs originated outside 
the United States and were not approved by FDA for introduction or 
delivery for introduction into interstate commerce in the United 
States. Thus, Dr. Bhandari caused the introduction or delivery for 
introduction into interstate commerce of prescription drugs that were 
misbranded for lacking adequate directions for use in their labeling.
    As a result of this conviction, on August 29, 2018, FDA sent Dr. 
Bhandari a notice by certified mail proposing to debar him for 3 years 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
a finding under section 306(b)(2)(B)(i)(I) of the FD&C Act, that Dr. 
Bhandari was convicted of a misdemeanor under Federal law for conduct 
relating to the regulation of drug products under the FD&C Act, and 
that the type of conduct that served as the basis for the conviction 
undermines the process for the regulation of drugs.
    The proposal offered Dr. Bhandari an opportunity to request a 
hearing, provided him 30 days from the date of receipt of the letter in 
which to file the request, and advised him that failure to request a 
hearing constituted a waiver of the opportunity for a hearing and of 
any contentions concerning this action. Dr. Bhandari received the 
proposal on September 4, 2018. Dr. Bhandari did not request a hearing 
within the timeframe prescribed by regulation and, therefore, has 
waived his opportunity for a hearing and has waived any contentions 
concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import 
Operations, Office of Regulatory Affairs, under section 
306(b)(2)(B)(i)(I) of the FD&C Act, under authority delegated to the 
Director (Staff Manual Guide 1410.35), finds that Dr. Bhandari has been 
convicted of a misdemeanor under Federal law for conduct relating to 
the regulation of drug products under the FD&C Act, and that the type 
of conduct that served as the basis for the conviction undermines the 
process for the regulation of drugs.
    As a result of the foregoing findings and in consideration of the 
factors described in section 306(c)(3) of the FD&C Act, Dr. Bhandari is 
debarred for a period of 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 (see DATES) (see sections 306(c)(1)(B), 
(c)(3), and 201(dd) of the FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(3), 
and 321(dd))). Any person with an approved or pending drug product 
application who knowingly employs or retains as a consultant or 
contractor, or otherwise uses the services of Dr. Bhandari, 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. 
Bhandari provides services in any capacity to a person with an approved 
or pending drug product application during his period of debarment 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. Bhandari during 
his period of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Bhandari for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2018-N-1989 and sent to the Dockets Management Staff (see 
ADDRESSES). All such submissions are to be filed in four copies. The 
public availability of information in these submissions is governed by 
21 CFR 10.20(j).
    Publicly available submissions will be placed in the docket and 
will be viewable at https://www.regulations.gov or at the Dockets 
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.


[[Page 66718]]


    Dated: December 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27951 Filed 12-26-18; 8:45 am]
BILLING CODE 4164-01-P