94-27724. John D. Copanos; Proposal to Debar; Opportunity for a Hearing  

  • [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]
    
    
    -----------------------------------------------------------------------
    
    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.
    
    -----------------------------------------------------------------------
    
    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
    
    
    

Document Information

Published:
11/09/1994
Department:
Food and Drug Administration
Entry Type:
Uncategorized Document
Action:
Notice.
Document Number:
94-27724
Dates:
Written requests for a hearing by December 9, 1994; information in support of the hearing request due by January 9, 1995.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: November 9, 1994, Docket No. 94N-0033