[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