[Federal Register Volume 59, Number 216 (Wednesday, November 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27724]
[[Page Unknown]]
[Federal Register: November 9, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0033]
John D. Copanos; Proposal to Debar; Opportunity for a Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to issue
an order permanently debarring Mr. John D. Copanos under the Federal
Food, Drug, and Cosmetic Act (the act). Once debarred, Mr. Copanos
would be prohibited from providing services in any capacity to a person
that has an approved or pending drug product application. FDA bases
this proposal on a finding that Mr. Copanos was convicted of a felony
under Federal law for conduct relating to the regulation of a drug
product under the act. This notice also offers Mr. Copanos an
opportunity for a hearing on the proposal. The agency is issuing this
notice in the Federal Register because all other appropriate means of
service of the notice upon Mr. Copanos have proven ineffective.
DATES: Written requests for a hearing by December 9, 1994; information
in support of the hearing request due by January 9, 1995.
ADDRESSES: Submit written requests for a hearing and supporting
information to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Megan L. Foster, Center for Drug
Evaluation and Research (HFD-366), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-2041.
SUPPLEMENTARY INFORMATION:
I. Conduct Related to Conviction
On November 13, 1989, Mr. Copanos agreed to plead guilty to one
count of distributing misbranded drugs with intent to defraud and
mislead, a Federal felony offense under 21 U.S.C. 331(a) and 333(a)(2)
(formerly 333(b)), and one count of manufacturing adulterated drugs
with intent to defraud and mislead, a Federal felony offense under 21
U.S.C. 331(k) and 333(a)(2). On February 16, 1990, the United States
District Court for the District of Maryland accepted Mr. Copanos' plea
of guilty and entered judgment against him for one count of
distributing misbranded drugs with intent to defraud and mislead. The
underlying facts supporting these felony convictions are as follows:
Mr. Copanos is and was, at the time of his criminal actions, the
owner and president of John D. Copanos and Sons, Inc., and Kanasco,
Ltd., both companies located at a common facility in Baltimore, MD. He
was directly responsible for the manufacturing, packaging, and shipping
of his firms' drug products for consumption by the public. Inherent in
these responsibilities was the duty to ensure that a drug was
manufactured in conformance with the current good manufacturing
practice (CGMP) regulations, incluing, but not limited to, the duty to
ensure that accurate manufacturing and testing records were ept and
that the components of the drugs were pure, safe, and unadulterated.
An investigation, conducted prior to Mr. Copanos' conviction,
revealed that he engaged in numerous illegal and fraudulent acts. In
April 1989, the U.S. Attorney for the District of Maryland filed a 20-
count indictment against him, his firms, and 3 employees of his firms.
In November 1989, he agreed to plead guilty to two counts of this
indictment.
The first count revealed that Mr. Copanos, along with other
employees of his firms, distributed a drug for public use that was
misbranded in that its labeling failed to bear adequate directions for
use because its labeling failed to warn of the presence of
phenylalanine, a component of aspartame. In fact, Mr. Copanos could not
accurately describe the conditions for use because he had not conducted
adequate testing to determine the effect of aspartame on the stability,
potency, and effectiveness of this drug. This drug was also misbranded
because its labeling was misleading in that it failed to reveal the
presence and amount of phenylalanine, information that is pertinent to
the treatment of children afflicted with phenylketonuria, who could
suffer irreversible mental retardation if they ingested too much
phenylalanine.
The second count for which Mr. Copanos was charged also revealed
his disregard for CGMP by his intentional failure to prepare and
maintain batch production and control records in order to disguise the
adulteration of several of his products. Specifically, Mr. Copanos
failed to prepare and maintain results of laboratory tests concerning
the sterility of his injectable drug products which tests showed that
the product samples tested were contaminated with bacteria.
II. FDA's Finding
Section 306(a)(2)(B) of the act (21 U.S.C. 335a(a)(2)(B) requires
debarment of an individual 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. Mr. Copanos' felony convictions for
distributing misbranded drugs and for manufacturing adulterated drugs
are both related to the regulation of a drug product in that the
convictions themselves are felony drug-related convictions under the
act. The illegal acts leading to the convictions are direct violations
of the primary legislation (the act) regulating drugs. In addition, the
convictions relate to, in part, Mr. Copanos' failure to follow the CGMP
regulations, which are enforced by FDA, to ensure the safety, identity,
strength, quality, and purity of drug products.
Under section 306(l)(2) of the act (21 U.S.C. 335a(1)(2)),
mandatory debarment pursuant to section 306(a)(2) applies to an
individual convicted of up to 5 years prior to initiation of agency
debarment action (such as this notice). Section 306(c)(2)(A)(ii) of the
act (21 U.S.C. 335a(c)(2)(A)(ii)) requires that Mr. Copanos' debarment
be permanent.
III. Proposed Action and Notice of Opportunity for a Hearing
Based on the findings discussed above, FDA proposes to issue an
order under section 306(a)(2)(B) of the act, permanently debarring Mr.
John D. Copanos from providing services in any capacity to a person
that has an approved or pending drug product application.
In accordance with section 306 of the act and 21 CFR part 12, Mr.
Copanos is hereby given an opportunity for a hearing to show why he
should not be debarred.
If Mr. Copanos decides to seek a hearing, he must file: (1) A
written notice of appearance and request for a hearing on or before
December 9, 1994; and (2) the information on which he relies to justify
a hearing on or before January 9, 1995. The procedures and requirements
governing this notice of opportunity for a hearing, a notice of
appearance and request for a hearing, information and analyses to
justify a hearing, and a grant or denial of a hearing are contained in
21 CFR part 12 and section 306(i) of the act (21 U.S.C. 335a(i)).
Mr. Copanos' failure to file a timely written notice of appearance
and request for a hearing constitutes an election by him not to use the
opportunity for a hearing concerning the action proposed, and a waiver
of any contentions concerning his debarment. If he does not request a
hearing in the manner prescribed by the regulations, the agency will
not hold a hearing and will issue the debarment order as proposed in
this notice.
A request for a hearing may not rest upon mere allegations or
denials but must present specific facts showing that there is a genuine
and substantial issue of fact that requires a hearing. If it
conclusively appears from the face of the information and factual
analyses in Mr. Copanos' request for a hearing that there is no genuine
and substantial issue of fact which precludes the order of debarment,
the Commissioner of Food and Drugs will enter summary judgment against
him, making findings and conclusions, and denying a hearing.
The facts underlying Mr. Copanos' conviction are not at issue in
this proceeding. The only material issue is whether Mr. Copanos was
convicted as alleged in this notice and, if so, whether, as a matter of
law, this conviction mandates his debarment.
A request for a hearing, including any information or factual
analyses relied on to justify a hearing, must be identified with Docket
No. 94N-0033, and sent to the Dockets Management Branch (address
above). All submissions pursuant to this notice of opportunity for a
hearing 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 may be seen in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
This notice is issued under section 306 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 335a) and under authority delegated to the
Interim Deputy Commissioner for Operations (21 CFR 5.20).
Dated: November 2, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-27724; Filed 11-8-94; 8:45 am]
BILLING CODE 4160-01-F