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###### Department of Health and Human Services

###### Food and Drug Administration

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

# Agency:

Food and Drug Administration, HHS.

# ACTION:

 Notice.

# 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:                          ( print 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.                

## 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                           ( print 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.

# Footnotes

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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