[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