[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, [email protected], 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]
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