[Federal Register Volume 75, Number 7 (Tuesday, January 12, 2010)]
[Notices]
[Pages 1623-1625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-289]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0305]


Jason Vale; 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 Jason Vale's 
request for a hearing and is issuing an order under the Federal Food, 
Drug, and Cosmetic Act (the act) permanently debarring Mr. Vale 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. Vale was convicted of a felony under Federal law for conduct 
relating to the regulation of a drug product under the act. Mr. Vale 
has failed to file with the agency information and analyses sufficient 
to create a basis for a hearing concerning this action.

DATES: The order is effective January 12, 2010.

ADDRESSES: Submit applications for termination of debarment to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: G. Matthew Warren, Office of 
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 301-796-4613.

SUPPLEMENTARY INFORMATION:

[[Page 1624]]

I. Background

    On July 21, 2003, a Federal jury found Mr. Vale, formerly the 
president of Christian Brother's Inc., guilty of three counts of 
criminal contempt in violation of 18 U.S.C. 401(3). On June 18, 2004, 
the U.S. District Court for the Eastern District of New York sentenced 
Mr. Vale to 63 months in prison on each of the three counts, to be 
served concurrently. On January 26, 2006, on remand from the Court of 
Appeals for the Second Circuit, the district court reduced the sentence 
to 60 months.
    Mr. Vale is subject to permanent debarment based on a finding, 
under section 306(a)(2) of the act (21 U.S.C. 335a(a)(2)), that he was 
convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product. Mr. Vale's convictions for contempt 
stemmed from his violation of consent decrees of preliminary and 
permanent injunction prohibiting him from distributing unapproved or 
misbranded drugs, including any drugs or other products, containing or 
purporting to contain, Laetrile, ``Vitamin B-17,'' amygdalin, or 
apricot seeds. The evidence introduced at Mr. Vale's criminal contempt 
trial showed that, in violation of the two injunctions, he continued to 
promote and sell amygdalin-based products and apricot seeds under a 
different business name. Mr. Vale acquired a post office box in Arizona 
under the name ``Praise Distributing'' (Praise), began referring former 
and incoming customers of Christian Brothers to a Praise phone number 
for purchase of those products, and continued to sell those products to 
his customers through Praise, with the assistance of others employed by 
Christian Brothers. Mr. Vale's convictions for criminal contempt under 
18 U.S.C. 401(3) related directly to the regulation of drug products 
under the act. By continuing to market amygdalin-based products and 
apricot seeds, Mr. Vale ignored two injunctions, which were intended to 
prevent him from violating the requirements for drug products in the 
act.
    By letter dated June 26, 2008, FDA served Mr. Vale a notice 
proposing to permanently debar him from providing services in any 
capacity to a person having an approved or pending drug product 
application. In a letter dated August 13, 2008, Mr. Vale requested a 
hearing on the proposal. In his request for a hearing, Mr. Vale 
acknowledges his convictions under Federal law, as alleged by FDA. 
However, he argues that his convictions for criminal contempt under 18 
U.S.C. 401(3) are not felony convictions subjecting him to permanent 
debarment under section 306(a)(2) of the act.
    We reviewed Mr. Vale's request for a hearing and find that Mr. Vale 
has not created a basis for a hearing because hearings will be granted 
only if there is a genuine and substantial issue of fact. Hearings will 
not be granted on issues of policy or law, on mere allegations, 
denials, or general descriptions of positions and contentions, or on 
data and information insufficient to justify the factual determination 
urged (see 21 CFR 12.24(b)).
    The Acting Chief Scientist and Deputy Commissioner has considered 
Mr. Vale's arguments and concludes that they are unpersuasive and fail 
to raise a genuine and substantial issue of fact requiring a hearing.

II. Argument

    Mr. Vale raises a single legal argument in support of his hearing 
request. Citing Frank v. United States, 395 U.S. 147, 149-52 (1969), he 
contends that his convictions for criminal contempt under 18 U.S.C. 
401(3) may not be characterized as felony convictions for purposes of 
section 306(a)(2) of the act because criminal contempt is not a felony 
under Federal law. An offense is typically a felony if the maximum term 
authorized is more than 1 year. (See 18 U.S.C. 3559(a)(1)-(5) 
(categorizing offenses as felonies if maximum terms of imprisonment are 
greater than 1 year); United States v. Wildes, 120 F.3d 468, 470 (4th 
Cir. 1997) (relying on 18 U.S.C. 3559 to conclude that a felony is any 
offense punishable by more than one year in prison)). Under 18 U.S.C. 
401, however, there is no specific term of imprisonment authorized; a 
Federal court has the power to punish criminal contempt by imprisonment 
``at its discretion.''
    In Frank, the U.S. Supreme Court addressed whether a particular 
offense under 18 U.S.C. 401 was ``petty'' or ``serious'' for purposes 
of the criminal contemnor's right to a jury trial under the Sixth 
Amendment. (395 U.S. at 148-52.) The Supreme Court acknowledged that 
criminal contempt is a sui generis offense (id. at n.5, citing Cheff v. 
Schnackenberg, 384 U.S. 373, 379-80 (1966)) in that ``a person may be 
found in contempt for a great many different types of offenses, ranging 
from disrespect for the court to acts otherwise criminal.'' (Frank, 395 
U.S. at 149.) But the Court found that ``in prosecutions for criminal 
contempt where no maximum penalty is authorized, the severity of the 
penalty actually imposed is the best indication of the seriousness of 
the particular offense.'' (Id.) The Court concluded that the particular 
offense at issue was ``petty'' because the contemnor received less than 
6 months in prison. (Id. at 152)
    In short, the Supreme Court held in Frank that, when sentence has 
been imposed, the length of that sentence is an appropriate measure for 
determining whether a criminal contempt conviction is a petty offense, 
misdemeanor, or felony.\1\ FDA will therefore look to the sentence 
imposed on Mr. Vale upon his conviction to evaluate whether his offense 
under 18 U.S.C. 401(3) was a felony. At 5 years for each conviction, 
Mr. Vale's sentences far exceeded 1 year, and thus his convictions were 
clearly for felony offenses. Accordingly, FDA concludes that all three 
of his convictions of criminal contempt subject him to mandatory 
debarment under section 306(a)(2) of the act.
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    \1\ There is, however, a split among the Federal Circuits with 
respect to whether a conviction for criminal contempt may be treated 
as a felony. The Court of Appeals for the Fifth Circuit has read the 
Supreme Court's decisions in Frank and Cheff to mean that criminal 
contempt can never be a felony. (United States v. Holmes, 822 F.2d 
481, 493-94 (5th Cir. 1987) (citing those cases for the proposition 
that criminal contempt is neither a misdemeanor nor a felony)). The 
Court of Appeals for the Ninth Circuit, however, has relied on the 
decision in Frank to conclude that a conviction of criminal contempt 
may be treated as a felony based on the defendant's sentencing 
range. (United States v. Carpenter, 91 F.3d 1282, 1283-86 (9th Cir. 
1996) (holding that courts should look to the appropriate sentencing 
guideline range to determine whether a particular offense under 18 
U.S.C. 401 is a felony); see also In re Cohn, 525 F.Supp.2d 1316, 
1321 (S.D.Fla. 2007) (holding that criminal contempt is always a 
Class A felony under 18 U.S.C. 3559(a) because the maximum sentence 
is life in prison)).
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III. Findings and Order

    Therefore, the Acting Chief Scientist and Deputy Commissioner, 
under section 306(a)(2)(B) of the act and under authority delegated to 
him, finds that Mr. Vale has been convicted of a felony under Federal 
law for conduct relating to the regulation of a drug product under the 
act.
    As a result of the foregoing findings, Mr. Vale is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application under section 505, 512, or 
802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351 of 
the Public Health Service Act (42 U.S.C. 262), (see DATES) (see section 
306(c)(1)(B) and (c)(2)(A)(ii) and section 201(dd) of the act (21 
U.S.C. 321(dd))). Any person with an approved or pending drug product 
application who knowingly uses the services of Mr. Vale, in any 
capacity during his period of debarment, will be subject to civil money 
penalties. If Mr. Vale, during his period of debarment, provides 
services in any capacity to a person with an

[[Page 1625]]

approved or pending drug product application, he will be subject to 
civil money penalties. In addition, FDA will not accept or review any 
ANDAs submitted by or with the assistance of Mr. Vale during his period 
of debarment.
    Any application by Mr. Vale for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. FDA-
2008-N-0305 and sent to the Division of Dockets Management (see 
ADDRESSES). 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: January 4, 2010.
Jesse L. Goodman,
Acting Chief Scientist and Deputy Commissioner for Science and Public 
Health.
[FR Doc. 2010-289 Filed 1-11-10; 8:45 am]
BILLING CODE 4160-01-S