Inspections, Compliance, Enforcement, and Criminal Investigations

03/22/1996

[Federal Register: March 22, 1996 (Volume 61, Number 57)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr96-97]

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93N-0008]

John W. Bushlow; Denial of Hearing; Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is denying a hearing for and is issuing a final order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Mr. John W. Bushlow, 9704 Tartuffe Dr., Richmond, VA 23233, from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Bushlow was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. Mr. Bushlow has failed to file with the agency information and analyses sufficient to create a basis for a hearing concerning this action.

EFFECTIVE DATE: March 22, 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: Tamar S. Nordenberg, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-2041.

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SUPPLEMENTARY INFORMATION:

  1. Background

    On February 21, 1992, the United States District Court for the District of Maryland entered judgment against Mr. John W. Bushlow, former Vice President of Manufacturing and plant manager of Vitarine Pharmaceuticals, Inc., for one count of failing to establish and maintain records, with the intent to mislead, a Federal felony offense under 21 U.S.C. 331(e) and 333(a)(2). As a result of this conviction, FDA served Mr. Bushlow by certified mail on April 9, 1993, a notice proposing to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application, and offered him an opportunity for a hearing on the proposal. The proposal was based on a finding, under section 306(a)(2)(B) of the act (21 U.S.C. 335a(a)(2)(B)), that Mr. Bushlow was convicted of a felony under Federal law for conduct relating to the regulation of a drug product.

    The certified letter informed Mr. Bushlow 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. The letter also notified Mr. Bushlow 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 May 4, 1993, Mr. Bushlow requested a hearing. The letter in its entirety is as follows:

    In accordance with the requirements of 21 U.S.C. 335a(i), I set forth below the information relied upon to justify a hearing on the Food and Drug Administration's Proposed Notice to Debar, dated February 5, 1993.

    1. The Proposal to Permanently Debar Violates the Double Jeopardy Clause of the Fifth Amendment
    2. The Proposed Notice to Permanently Debar violates the Ex Post Facto Clause of the Constitution
  2. The Proposed Notice to Permanently Debar violates the Constitution in that it is too broad, too vague and too unspecific.

    In accordance, and within the required 60 days from receipt of the Proposal to Debar Notice, additional information will be filed to justify a hearing.

    Despite his stated intention, Mr. Bushlow did not follow up with additional information to justify a hearing.

    The Deputy Commissioner for Operations has considered Mr. Bushlow's letter and concludes that it is unpersuasive and fails to raise a genuine and substantial issue of fact requiring a hearing. The constitutional claims that Mr. Bushlow offers do not create a basis for a hearing because hearings are not granted on matters of policy or law, but only on genuine and substantial issues of fact (21 CFR 12.24(b)(1)). The constitutional arguments are, in any event, unconvincing, for the reasons discussed below.

  3. Mr. Bushlow's Arguments in Support of a Hearing

    Mr. Bushlow states that the debarment proposal violates the Ex Post Facto Clause and Double Jeopardy Clause of the U.S. Constitution. Mr. Bushlow was convicted on February 21, 1992, prior to the enactment of the Generic Drug Enforcement Act (GDEA) on May 13, 1992.

    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).)

    The Double Jeopardy Clause states that no person shall ``be subject for the same offense to be twice put in jeopardy of life or limb.''

    In determining whether a statutory provision such as the one being challenged is unconstitutional under the Ex Post Facto Clause or Double Jeopardy Clause, the critical consideration is whether the provision is remedial or punitive in nature. The intent of debarment under the GDEA is not to punish, but rather to remedy the past fraud and corruption in the drug industry. In upholding the GDEA against an ex post facto challenge, the court in Bae v. Shalala stated,

    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); see also, Manocchio v. Kusserow, 961 F.2d 1539, 1542 (11th Cir. 1992); Hawker v. New York, 170 U.S. 189, 190 (1898); DeVeau v. Braisted, 373 U.S. 154 (1960).) Therefore, Mr. Bushlow's claim that the GDEA violates the Ex Post Facto Clause and Double Jeopardy Clause is unpersuasive.

    Mr. Bushlow also asserts that the proposal to debar him is unconstitutional because it is "too broad, too vague, and too unspecific." Such an argument does not provide the basis for a hearing.

    Neither the proposal to debar nor the act's debarment provisions, on which the proposal to debar was based, are vague or unspecific. The debarment proposal sets forth expressly the conduct on which the proposal is based, the findings of FDA, the agency's proposed action, and the procedure for requesting a hearing. Section 306(a)(2)(B) of the act clearly mandates the debarment of an individual who has been convicted of a Federal felony for conduct relating to the regulation of any drug product. The act defines the conduct and felony conviction that lead to debarment. The period of debarment is also set forth in section 306(c)(2) of the act, which states that the debarment is permanent.

    Finally, Mr. Bushlow does not explain his argument that the debarment proposal is over broad. In fact, the debarment provisions are narrowly drawn to accomplish the legitimate government purposes of ensuring the integrity of the drug regulatory process and protecting the public health. The debarment provisions further the compelling governmental interest of "restor[ing] consumer confidence in generic drugs by eradicating the widespread corruption in the generic drug approval process." (Bae v. Shalala, 44 F.3d 489, 493 (7th Cir. 1995).)

    Mr. Bushlow does not dispute the fact that he was convicted as alleged by FDA in its proposal to debar him, and he has raised no genuine and substantial issue of fact regarding this conviction. Also, Mr. Bushlow's legal arguments do not create a basis for a hearing and, in any event, are unpersuasive. Accordingly, the Deputy Commissioner for Operations denies Mr. Bushlow's request for a hearing.

  4. 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 Mr. John W. Bushlow has been convicted of a felony 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, Mr. John W. Bushlow is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 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 March 22, 1996, (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C. 321(dd)). Any person with an approved or pending drug product application who knowingly uses the

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    services of Mr. Bushlow, in any capacity, during his period of debarment, will be subject to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6)). If Mr. Bushlow, 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 civil money penalties (section 307(a)(7) of the act). In addition, FDA will not accept or review any abbreviated new drug applications from Mr. Bushlow during his period of debarment.

    Any application by Mr. Bushlow for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 93N- 0008 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: March 3, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-6941 Filed 3-21-96; 8:45 am]
BILLING CODE 4160-01-F

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