[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Notices]
[Pages 27235-27236]
From the Federal Register Online via the Government Printing 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