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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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03/22/1996

[Federal Register: March 22, 1996 (Volume 61, Number 57)]

[Notices]              

[Page 11846-11848]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr22mr96-97]

 

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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