[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44899-44900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5923]


Paul J. Elmer: Final 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 (the FD&C Act) 
permanently debarring Paul J. Elmer 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. Elmer was 
convicted of a felony under Federal law for conduct that relates to the 
regulation of a drug product under the FD&C Act. Mr. Elmer was given 
notice of the proposed permanent debarment and was given an opportunity 
to request a hearing to show why he should not be debarred. As of March 
11, 2020 (30 days after receipt of the notice), Mr. Elmer had not 
responded. Mr. Elmer's failure to respond and request a hearing 
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is applicable July 24, 2020.

ADDRESSES: Submit applications for special 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: Jaime Espinosa (ELEM-4029) Division of 
Enforcement, Office of Strategic Planning and Operational Policy, 
Office of Regulatory Affairs, Food and Drug Administration, 12420 
Parklawn Dr., Rockville, MD 20857, debarments@fda.hhs.gov, or at 240-
402-8743.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) 
requires debarment of an individual from providing services in any 
capacity to a person that has an approved or pending drug product 
application if FDA finds that the individual has been convicted of a 
felony under Federal law for conduct relating to the regulation of any 
drug product under the FD&C Act. On September 23, 2019, Mr. Elmer was 
convicted as defined in section 306(l)(1) of the FD&C Act when judgment 
was entered against him in the U.S. District Court for the Southern 
District of Indiana to one count of conspiracy in violation of 18 
U.S.C. 371, three counts of introduction of adulterated drugs into 
interstate commerce in violation of 21 U.S.C. 331(a), 333(a)(1), and 
351, and six counts of adulterating drugs while holding for sale after 
shipment in interstate commerce in violation of 21 U.S.C. 331(k), 
333(a)(1), and 351.
    The factual basis for this conviction is as follows: as contained 
in in counts 1 and 3-11 of the indictment, filed on February 7, 2019, 
Mr. Elmer was the president and owner of Pharmakon Pharmaceuticals, 
Inc. (Pharmakon). Pharmakon compounded sterile drugs for public, 
private, and military hospitals and medical centers located throughout 
the United States. In that capacity Mr. Elmer conspired to defraud the 
United States by interfering with and obstructing, through deceitful 
and dishonest means, the lawful functions of FDA and to commit an 
offense against the United States by corruptly influencing, 
obstructing, and impeding, and endeavoring to influence, obstruct, and 
impede, the due and proper administration of the law under which a 
pending proceeding was being had before an agency of the United States, 
specifically FDA inspections of Pharmakon. Among other things, Mr. 
Elmer and his co-conspirators provided or directed others to provide 
false statements, during three inspections and in related 
correspondence, to FDA regarding the practices at Pharmakon. In 
addition, on three separate occasions Mr. Elmer introduced and 
delivered for introduction into interstate commerce, and caused to be 
introduced and delivered for introduction into interstate commerce, 
adulterated drugs which were adulterated because the drugs were

[[Page 44900]]

purported to be and represented as drugs which were recognized in an 
official compendium and the strength of such drugs differed from the 
standard set forth in such compendium: fentanyl, promethazine, and 
morphine sulfate. On six other occasions Mr. Elmer caused drugs, that 
were being held for sale after the shipment of a drug component in 
interstate commerce, to become adulterated because the drugs were 
purported to be and represented as drugs which were recognized in an 
official compendium and the strength of such drugs differed from the 
standard set forth in such compendium: midazolam, fentanyl citrate, 
phenylephrine, and morphine sulfate.
    As a result of this conviction, FDA sent Mr. Elmer by certified 
mail on February 3, 2020, a notice proposing to permanently debar him 
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(a)(2)(B) of the FD&C Act, that Mr. Elmer 
was convicted of felonies under Federal law for conduct relating to the 
regulation of a drug product under the FD&C Act. The proposal also 
offered Mr. Elmer 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 
an election not to use the opportunity for a hearing and a waiver of 
any contentions concerning this action. Mr. Elmer received the proposal 
on February 10, 2020. Mr. Elmer did not request a hearing within the 
timeframe prescribed by regulation and has, therefore, waived his 
opportunity for a hearing and any contentions concerning his debarment 
(21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal 
Food Operations, under section 306(a)(2)(B) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Paul J. 
Elmer, has been convicted of a felony under Federal law for conduct 
otherwise relating to the regulation of a drug product under the FD&C 
Act.
    As a result of the foregoing finding, Paul J. Elmer, is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application, effective (see DATES) 
(see sections 306(a)(2)(B) and 306(c)(2)(A)(ii) 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 Paul J. Elmer, 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 Mr. Elmer 
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 from Mr. Elmer during his period of debarment, other 
than in connection with an audit under section 306 of the FD&C Act 
(section 306(c)(1)(B) of the FD&C Act). Note that, for purposes of 
section 306 of the FD&C Act, a ``drug product'' is defined as a drug 
subject to regulation under section 505, 512, or 802 of the FD&C Act 
(21 U.S.C. 355, 360b, 382) or under section 351 of the Public Health 
Service Act (42 U.S.C. 262) (section 201(dd) of the FD&C Act (21 U.S.C. 
321(dd))).
    Any application by Mr. Elmer for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2019-N-5923 and sent to the Dockets Management Staff 
(see ADDRESSES). The public availability of information in these 
submissions is governed by 21 CFR 10.20.
    Publicly available submissions may be seen in the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 17, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16069 Filed 7-23-20; 8:45 am]
BILLING CODE 4164-01-P


