[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)]
[Notices]
[Pages 63657-63658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26722]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1994]


David J. Fishman: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. 
David J. Fishman 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. Fishman 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. 
Fishman was given notice of the proposed debarment and an opportunity 
to request a hearing within the timeframe prescribed by regulation. Dr. 
Fishman failed to request a hearing. Dr. Fishman's failure to

[[Page 63658]]

request a hearing constitutes a waiver of his right to a hearing 
concerning this action.

DATES: This order is applicable December 11, 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, 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 November 19, 2013, in the United States District Court for the 
Northern District of Ohio, judgment was entered against Dr. Fishman 
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 January 10, 2006, and March 12, 2009, 
Dr. Fishman was a physician (oncologist) in Ohio. During this time, Dr. 
Fishman purchased and received oncology drugs, including TAXOTERE 
(docetaxel) and NOVANTRONE (mitoxantrone), 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. 
Fishman 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 July 27, 2018, FDA sent Dr. 
Fishman 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. 
Fishman 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. Fishman an opportunity to request a 
hearing, providing 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. Fishman received the 
proposal on August 2, 2018. Dr. Fishman did not request a hearing 
within the timeframe prescribed by regulation and has, therefore, 
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. David J. Fishman 
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. David J. 
Fishman 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 (see DATES) (see sections 306(c)(1)(B), (c)(3), and 
201(dd) (21 U.S.C. 321(dd)) of the FD&C Act). 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. Fishman 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. Fishman 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. Fishman during his period of debarment (section 
306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Fishman for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2018-N-1994 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.

    Dated: December 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26722 Filed 12-10-18; 8:45 am]
 BILLING CODE 4164-01-P