[Federal Register Volume 61, Number 57 (Friday, March 22, 1996)]
[Notices]
[Pages 11846-11848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6941]



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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.

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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.


[[Page 11847]]

SUPPLEMENTARY INFORMATION:
I. 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.
    I. The Proposal to Permanently Debar Violates the Double 
Jeopardy Clause of the Fifth Amendment
    II. The Proposed Notice to Permanently Debar violates the Ex 
Post Facto Clause of the Constitution
    III. 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.
II. 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.
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 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

[[Page 11848]]

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