[Federal Register Volume 61, Number 48 (Monday, March 11, 1996)]
[Notices]
[Pages 9711-9713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5687]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0033]
John D. Copanos; Denial of Hearing; Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) denies John D. Copanos'
request for a hearing and issues a final order under section 306(a) of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 335a(a))
permanently debarring John D. Copanos, 6504 Montrose Ave., Baltimore,
MD 21212, from providing services in any capacity to a person that has
an approved or pending drug product application. FDA bases this order
on its 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.
EFFECTIVE DATE: March 11, 1996
ADDRESSES: Application for termination of debarment to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., Rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-2041.
SUPPLEMENTARY INFORMATION:
I. Background-
John D. Copanos was the owner and president of John D. Copanos and
Sons, Inc., and Kanasco, Ltd., when, on November 13, 1989, he agreed to
plead guilty to one count of distributing misbranded drugs with intent
to mislead, a Federal felony offense under sections 301(a) of the act
(21 U.S.C. 331(a)) and 303(a)(2)(previously 303(b)) of the act (21
U.S.C. 333(a)(2)) (previously 21 U.S.C. 333(b)), and one count of
causing the adulteration of drugs with intent to mislead, a Federal
felony offense under sections 301(k) and 303(a)(2) of the act. 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 these felonies. The bases for these convictions were as
follows.
Mr. Copanos distributed a drug that was misbranded because its
labeling failed to bear adequate directions for use and because it
failed to warn of the presence of phenylalanine, a component of
aspartame. In fact, adequate testing had not been conducted to
determine the effect of aspartame on the stability, potency, and
effectiveness of this drug. This drug was also misbranded because it
failed to reveal the presence and amount of phenylalanine.
In addition, Mr. Copanos pled guilty to causing the adulteration of
a drug with intent to mislead by failing to comply with current good
manufacturing practice.
In a notice published in the Federal Register of November 9, 1994
(59 FR 55846), FDA offered Mr. Copanos an opportunity for a hearing on
the agency's proposal to issue an order under section 306(a) of the act
debarring Mr. Copanos from providing services in any capacity to a
person that has an approved or pending drug product application. FDA
based the proposal to debar Mr. Copanos on its finding that he had been
convicted of felonies under Federal law for conduct relating to the
regulation of a drug product. -
In the Federal Register notice of November 9, 1994, FDA informed
Mr. Copanos that his request for a hearing could not rest upon mere
allegations or denials but must present specific facts showing that
there was a genuine and substantial issue of fact requiring a hearing.
FDA also informed Mr. Copanos that if it conclusively appeared from the
face of the information and factual analyses in his request for a
hearing that there was no genuine and substantial issue of fact which
precluded the order of debarment, FDA would enter summary judgment
against him and deny his request for a hearing.
In a letter dated December 8, 1994, Mr. Copanos requested a
hearing, and in a letter dated January 6, 1995, Mr. Copanos submitted
arguments and information in support of his hearing request. In his
request for a hearing, Mr. Copanos does not dispute that he was
convicted of a felony under Federal law as alleged by FDA. However, Mr.
Copanos argues that: (1) He did not receive proper notice; (2) he is
entitled to a hearing to contest or explain the facts underlying his
plea; (3) some factual statements in the agency's proposal are
inaccurate; (4) the agency's reliance on portions of the indictment is
inappropriate; (5) and the agency's proposal to debar him is
unconstitutional.
The Deputy Commissioner for Operations has considered Mr. Copanos'
arguments and concludes that they are unpersuasive and fail to raise a
genuine and substantial issue of fact requiring a hearing. Moreover,
the legal arguments that Mr. Copanos offers do not create the bases for
a hearing (see 21 CFR 12.24(b)(1)). Mr. Copanos' arguments are
discussed below.
II. Mr. Copanos' Arguments in Support of a Hearing
A. Notice
Mr. Copanos objects to being notified of his proposed debarment
through publication in the Federal Register. It is the policy of the
agency to send a notice of proposed debarment by certified mail. If
certified mail delivery is unsuccessful, the agency attempts to deliver
the notice to the individual personally. If this attempt fails also,
[[Page 9712]]
notice is given through publication in the Federal Register. FDA
attempted to serve Mr. Copanos by certified mail but was unable to do
so. In September 1994, FDA's Baltimore District Office learned that Mr.
Copanos was out of the country. Agents from FDA's Baltimore District
Office visited Mr. Copanos' home weekly to determine if he had
returned. FDA's Office of Criminal Investigation arranged with U.S.
Customs to be notified if Mr. Copanos returned to the country. When Mr.
Copanos did not return to the country, the debarment notice was
published in the Federal Register on November 9, 1994.
Mr. Copanos requested a hearing on his proposed debarment and made
arguments in support of that request. Thus, it is clear that Mr.
Copanos received actual notice of the agency's proposed action and has
not been deprived of any procedural rights by virtue of publication of
the debarment notice in the Federal Register.
B. Facts Underlying the Plea
Mr. Copanos makes the following statements relating to the facts
underlying his plea. He states that he held a management position and
did not personally misbrand or manufacture adulterated drugs, that none
of the drugs or products involved were put into commerce, and that the
first count of the plea related to a facility that was not under his
full control at the time. Mr. Copanos also states that the agency's
proposal sets forth areas of indictment information and factual
statements of allegations rather than actual proof.
Mr. Copanos is correct that the agency's proposal contained some
inaccuracies. Although Mr. Copanos pled guilty to counts four and six
of the indictment against him, he did not plead guilty to all the
particulars listed in the indictment. In its debarment proposal, the
agency mistakenly referred to parts of the indictment to which Mr.
Copanos did not plead. The agency very much regrets this error.
However, this misplaced reliance does not raise a genuine and
substantial issue of fact requiring a hearing.
The act requires FDA to mandatorily debar an individual who has
been convicted of certain Federal felonies. The only relevant factual
issue is whether Mr. Copanos was, in fact, convicted. Mr. Copanos does
not dispute that he pled guilty to two Federal felony counts for
actions that relate to the regulation of a drug product. Section 306(l)
of the act includes in its definition of a conviction, a guilty plea.
Accordingly, Mr. Copanos' statements regarding the factual
circumstances underlying his plea fail to raise a genuine and
substantial issue of fact justifying a hearing.
C. Ex Post Facto Argument
Mr. Copanos argues that the ex post facto clause of the U.S.
Constitution prohibits application of section 306(a)(2) of the act to
him because this section was not in effect at the time of Mr. Copanos'
criminal conduct. The Generic Drug Enforcement Act (GDEA) of 1992,
including section 306(a)(2), was enacted on May 13, 1992, and Mr.
Copanos was convicted on February 16, 1990.
An ex post facto law is one that reaches back to punish acts that
occurred before enactment of the law or that adds a new punishment to
one that was in effect when the crime was committed. (Ex Parte Garland,
4 Wall. 333, 377, 18 L. Ed. 366 (1866); Collins v. Youngblood, 497 U.S.
37 (1990).)
Mr. Copanos' claim that application of the mandatory debarment
provisions of the act is prohibited by the ex post facto clause is
unpersuasive, because the intent of debarment is remedial, not
punitive. Congress created the GDEA in response to findings of fraud
and corruption in the generic drug industry. Both the language of the
GDEA and its legislative history reveal that the purpose of the
debarment provisions set forth in the GDEA is ``to restore and ensure
the integrity of the abbreviated new drug application (ANDA) approval
process and to protect the public health.'' (See section 1, Pub. L.
102-282, GDEA of 1992.)
In a suit challenging a debarment order issued by FDA (58 FR 69368,
December 30, 1993), the constitutionality of the debarment provision
was upheld against a similar challenge under the ex post facto clause.
The reviewing court affirmed the remedial character of debarment:
Without question, the GDEA serves compelling governmental
interests unrelated to punishment. The punitive effects of the GDEA
are merely incidental to its overriding purpose to safeguard the
integrity of the generic drug industry while protecting public
health.
Bae v. Shalala, 44 F.3d 489, 493 (7th Cir. 1995). Because the intent of
the GDEA is remedial rather than punitive, Mr. Copanos' argument that
the GDEA violates the ex post facto clause must fail. See id. at 496-
97.
D. Miscellaneous Arguments
Mr. Copanos argues that his debarment would be ``an
unconstitutional taking of the right to earn a living in the United
States.'' It appears that Mr. Copanos is referring to a ``taking'' of
property under the Fifth Amendment. Mr. Copanos further states that he
has sold his company, including all of its approved applications, and
that to debar him now ``1would be a malicious act'' on the part of the
agency. Mr. Copanos also argues that he should not be debarred because
his guilty plea was made at an emotional and stressful time.
None of these arguments raise a genuine and substantial issue of
fact requiring resolution at a hearing. Mr. Copanos has not established
that his debarment affects any property interest protected by the Fifth
Amendment. The expectation of employment is not recognized as a
protected property interest under the Fifth Amendment. Hoopa Valley
Tribe v. Christie, 812 F.2d 1097, 1102 (9th Cir. 1986); Chang v. United
States, 859 F.2d 893, 896-97 (Fed. Cir. 1988). Loss of potential profit
is not a sufficient basis for a ``takings'' claim. Andrus v. Allard,
444 U.S. 51, 66 (1979). To have a protected property interest, one must
have a ``legitimate claim of entitlement'' to that interest. Erikson v.
United States, 67 F.3d 858 (9th Cir. 1995). One who voluntarily enters
a pervasively regulated industry, such as the pharmaceutical industry,
and then violates its regulations, cannot successfully claim that he
has a protected property interest when he is no longer entitled to the
benefits of that industry. Id.
Mr. Copanos does not dispute that he was convicted as alleged by
FDA. Under section 306(l)(1)(B) of the act a conviction includes a
guilty plea. The facts underlying Mr. Copanos' conviction are not at
issue. Moreover, the act does not permit consideration of factors such
as emotional stress; rather, the act is clear that an individual shall
be debarred if convicted of a felony under Federal law for conduct
relating to the regulation of any drug product (see section
306(a)(2)(B) of the act). Mr. Copanos has been convicted of such a
felony. Accordingly, the Deputy Commissioner for Operations denies Mr.
Copanos' request for a hearing.
III. Findings and Order
Therefore, the Deputy Commissioner for Operations, under section
306(a) of the act and under authority delegated to him (21 CFR 5.20),
finds that John D. Copanos has been convicted of felonies under Federal
law for conduct relating to the regulation of a drug product (21 U.S.C.
335a(a)(2)(B)).
As a result of the foregoing findings, John D. Copanos is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application
[[Page 9713]]
under section 505, 507, 512, or 802 of the act (21 U.S.C. 355, 357,
360b, or 382), or under section 351 of the Public Health Service Act
(42 U.S.C. 262), effective (insert date of publication in the Federal
Register), (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii)). Any person with
an approved or pending drug product application who knowingly uses the
services of Mr. Copanos, in any capacity, during his period of
debarment, will be subject to a civil money penalty (section 307(a)(6)
of the act (21 U.S.C. 335b(a)(6))). If Mr. Copanos, during his period
of debarment, provides services in any capacity to a person with an
approved or pending drug product application, he will be subject to a
civil penalty (section 307(a)(7) of the act). In addition, FDA will not
accept or review any ANDA or abbreviated antibiotic drug application
submitted by or with Mr. Copanos' assistance during his period of
debarment.
Mr. Copanos may file an application to attempt to terminate his
debarment pursuant to section 306(d)(4)(A) of the act. Any such
application would be reviewed under the criteria and processes set
forth in section 306(d)(4)(C) and (d)(4)(D) of the act. Such an
application should be identified with Docket No. 94N-0033 and sent to
the Dockets Management Branch (address above). 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 may be seen in the Dockets Management Branch between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: February 22, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-5687 Filed 3-8-96; 8:45 am]
BILLING CODE 4160-01-F
