[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Notices]
[Pages 27235-27236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-11106]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0442]


Jerome Lentini; 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 Jerome 
Lentini's request for a hearing and is issuing an order under the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently 
debarring Lentini 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 Lentini was convicted of a felony under 
Federal law for conduct relating to the development or approval of a 
drug product or otherwise relating to the regulation of a drug product 
under the FD&C Act. Lentini 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 May 9, 2012.

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. Bldg. 32, Rm. 4210, Silver Spring, MD 20993, 301-796-4613.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 11, 2006, the United States District Court for the 
District of Oregon entered a criminal judgment against Lentini pursuant 
to his guilty plea. Lentini, formerly a medical doctor at ``A Younger 
You'' clinic, pled guilty to a felony under the FD&C Act, namely 
misbranding a drug with an intent to defraud or mislead while it was 
held for sale after shipment in interstate commerce in violation of 
sections 301(k) and 303(a)(2) of the FD&C Act (21 U.S.C. 331(k) and 
333(a)(2)) and 18 U.S.C. 2. The basis for this conviction was Lentini's 
admission that he misled patients from November 2003 through December 
2004, by injecting them with a drug product that he offered for sale as 
BOTOX/BOTOX Cosmetic (BOTOX). In fact, as defendant Lentini knew, he 
did not generally use BOTOX on patients but instead used another drug 
derived from botulinum toxin type A that had not been approved by FDA.
    Lentini is subject to debarment based on a finding, under section 
306(a)(2) of the FD&C Act (21 U.S.C. 335a(2)), that he was convicted of 
a felony under Federal law for conduct relating to the development or 
approval of a drug product or otherwise relating to the regulation of a 
drug product under the FD&C Act. By letter dated February 7, 2011, FDA 
notified Lentini of a proposal 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 February 19, 2011, Lentini 
requested a hearing on the proposal. In his request for a hearing, 
Lentini acknowledges his convictions under Federal law, as alleged by 
FDA, but he argues that he is actually innocent of the offense 
underlying his felony conviction.
    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 Chief Scientist and Deputy Commissioner for Science and Public 
Health has considered Lentini's arguments and concludes that they are 
unpersuasive and fail to raise a genuine and substantial issue of fact 
requiring a hearing.

II. Arguments

    In his request for a hearing, Lentini first argues that he did not 
misbrand the drug product at issue. Instead, he argues that the 
manufacturer of the drug product, Toxin Research International, Inc. 
(TRI), misbranded the product. As stated in the indictment in Lentini's 
criminal proceedings, however, a drug is misbranded under section 
502(i)(3) of the FD&C Act (21 U.S.C. 352(i)(3)) if a drug ``is offered 
for sale under the name of another drug.'' The specific count to which 
Lentini pled guilty charged him with ``misbrand[ing] a drug, namely

[[Page 27236]]

Botulinum Toxin Type A manufactured by [TRI] and known as `TRI-toxin,' 
* * * in that [he] offered the ``TRI-toxin for sale by injection to 
patients under the name of another drug, [BOTOX].'' In short, Lentini 
pled guilty to, and was convicted of, misbranding a drug under the FD&C 
Act.
    Section 306(a)(2) of the FD&C Act provides FDA with authority debar 
an individual who has been convicted of certain Federal felonies. The 
only relevant factual issue is whether Lentini was, in fact, convicted 
of a felony under Federal law for conduct relating to the development 
or approval of a drug product or otherwise relating to the regulation 
of a drug product under the FD&C Act. Lentini does not dispute that he 
pled guilty to violating the requirements for drugs under the FD&C Act. 
Section 306(l) of the FD&C Act includes in its definition of a 
conviction, a guilty plea. Accordingly, Lentini's arguments regarding 
the factual circumstances underlying his plea fail to raise a genuine 
and substantial issue of fact as to whether he was convicted of a 
felony under Federal law for conduct relating to the development or 
approval of a drug product or otherwise relating to the regulation of a 
drug product under the FD&C Act. Whether TRI also misbranded the drug 
is immaterial to the conduct underlying Lentini's conviction.
    Lentini next argues that he entered the guilty plea underlying his 
felony conviction while under ``extreme duress'' and only because his 
attorneys advised him that the prosecution would ``find a way to 
convict him legally or illegally'' and that he should sign the plea 
agreement ``despite the facts.'' In Lentini's petition to enter a 
guilty plea in the criminal proceedings, however, he specifically 
attested that he was voluntarily agreeing to plead guilty because he 
was guilty of the offense underlying his conviction. He also stated in 
the petition that he had carefully reviewed every part of the agreement 
with his attorney and that the attorney counseled and advised him on 
the nature and elements of the charge to which he was pleading guilty, 
as well as any possible defenses. Under these circumstances, and in 
light of the court's acceptance of his guilty plea, Lentini's mere 
allegation that he was actually innocent of the offense and signed the 
plea agreement only at the urging of his attorney is insufficient to 
create a genuine and substantial issue of fact for resolution at a 
hearing. (See 21 CFR 12.24(b)(1)-(2)). Moreover, the FD&C Act does not 
permit consideration of factors such as the circumstances of an 
individual's guilty plea. As stated in this document, section 306(a)(2) 
the FD&C Act is clear that an individual shall be debarred upon a 
finding that he has been convicted of a felony under Federal law for 
conduct relating to the development or approval of a drug product or 
otherwise relating to the regulation of a drug product under the FD&C 
Act. Lentini has been convicted of such a felony and is thus subject to 
debarment. If a court were to reverse Lentini's conviction on the 
ground that his plea was involuntary, or for any other reason, the 
order of debarment would be withdrawn pursuant to section 
306(d)(3)(B)(i) of the FD&C Act.

III. Findings and Order

    Therefore, the Chief Scientist and Deputy Commissioner for Science 
and Public Health, under section 306(a)(2) of the FD&C Act and under 
authority delegated to him, finds that Mr. Lentini has been convicted a 
of a felony under Federal law for conduct relating to the development 
or approval of a drug product or otherwise relating to the regulation 
of a drug product under the FD&C Act.
    As a result of the foregoing findings, Lentini 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 FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 
of the Public Health Service Act (42 U.S.C. 262), effective May 9, 2012 
(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 services of Lentini, in any capacity during his 
period of debarment, will be subject to civil money penalties. If 
Lentini, 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. In addition, 
FDA will not accept or review any abbreviated new drug applications 
submitted by or with the assistance of Lentini during his period of 
debarment.
    Any application by Lentini for termination of debarment under 
section 306(d) of the FD&C Act should be identified with Docket No. 
FDA-2010-N-0442 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 Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. 
Persons with access to the Internet may obtain documents in the Docket 
at http://www.regulations.gov.

    Dated: April 16, 2012.
Jesse L. Goodman,
Chief Scientist and Deputy Commissioner for Science and Public Health.
[FR Doc. 2012-11106 Filed 5-8-12; 8:45 am]
BILLING CODE 4160-01-P