[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:
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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