Inspections, Compliance, Enforcement, and Criminal Investigations
[Federal Register: March 11, 1996 (Volume 61, Number 48)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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, 1996ADDRESSES: 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.
- Mr. Copanos' Arguments in Support of a Hearing
- Facts Underlying the Plea
- Ex Post Facto Argument
- Miscellaneous Arguments
- Findings and Order
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.
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,
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.
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.
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.
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.
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
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