[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15790-15791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05714]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3591]


Gerald Tighe: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
permanently debarring Gerald Tighe 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. Tighe was 
convicted of a felony under Federal law for conduct that relates to the 
regulation of a drug product under the FD&C Act. Mr. Tighe was given 
notice of the proposed permanent debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Mr. 
Tighe failed to respond. Mr. Tighe's failure to request a hearing 
within the prescribed timeframe constitutes a waiver of his right to a 
hearing concerning this action.

DATES: This order is applicable March 19, 2020.

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

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of 
Enforcement, Office of Strategic Planning and Operational Policy, 
Office of Regulatory Affairs, Food and Drug Administration, 12420 
Parklawn Dr., Rockville, MD 20857, debarments@fda.hhs.gov, or 240-402-
8743.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) 
requires debarment of an individual if FDA finds that the individual 
has been convicted of a felony under Federal law for conduct relating 
to the regulation of any drug product under the FD&C Act. On July 14, 
2017, Mr. Tighe pleaded guilty to one count of conspiracy to commit 
wire fraud, a felony offense, in violation of 18 U.S.C. 371. On 
December 19, 2017, judgment was entered against Mr. Tighe in the U. S. 
District Court for the Eastern District of New York.
    The factual basis for this conviction is as follows: Mr. Tighe was 
the founder, sole owner, and president of Med Prep Consulting, Inc. 
(Med Prep), a medical drug repackager located and incorporated in New 
Jersey in 1994. Med Prep manufactured, repackaged, processed, packed, 
labeled, held, compounded, and distributed various drug products, 
including pain management medications, anesthesia and operating room 
drugs, and oncology and dialysis drugs. As president of Med Prep, Mr. 
Tighe was the highest-ranking corporate official, and he was 
responsible for and oversaw all aspects of its business, including its 
manufacturing and quality operations. Between approximately January 
2007 and April 2013, Mr. Tighe knowingly and intentionally conspired 
with other individuals to devise a scheme and artifice to defraud 
healthcare providers and to obtain money and property from them by 
means of materially false and fraudulent pretenses, representations, 
and promises, and for the purpose of executing such scheme and 
artifice, and attempting to do so, to transmit and cause to be 
transmitted, by means of wire communication in interstate commerce, 
writings, signs, signals, pictures, and sounds.
    Specifically, during this time period, Mr. Tighe conspired with 
others to introduce and introduced, or caused the introduction of, 
adulterated and misbranded drugs into interstate commerce, all with the 
intent to defraud and mislead healthcare providers. The adulterated 
drugs Mr. Tighe introduced or caused to be introduced into interstate 
commerce were adulterated because they were prepared, packed, and held 
under insanitary conditions and because the drugs consisted in whole or 
in part of a filthy, putrid, and decomposed substance. The misbranded 
drugs Mr. Tighe introduced or caused to

[[Page 15791]]

be introduced in interstate commerce were misbranded because the drugs 
were dangerous to health when used as labeled and because the labeling 
on the drugs regarding use by dates and the strength of the ingredients 
were false and misleading. Mr. Tighe assured healthcare providers that 
they were receiving drug products from Med Prep that were produced in 
full compliance with the law, were compounded and packaged in 
compliance with chapter 797 of the United States Pharmacopeia (USP 797) 
and would be safe for patients. Mr. Tighe also told healthcare 
providers that the beyond use dates that Mr. Tighe assigned to sterile 
drug products were supported by sterility testing that satisfied the 
requirements of USP 797. These representations were made in, among 
other places, quarterly reports that were sent by email to healthcare 
providers and on Med Prep's website. Mr. Tighe did not inform 
healthcare providers of failures to comply with USP 797 and basic 
sterility practices, and breaches of aseptic technique in Med Prep's 
cleanroom, which occurred repeatedly at Med Prep's facility.
    By engaging in this conduct, Mr. Tighe violated Federal and State 
law applicable to drug preparation and created serious risks for 
patients who were being treated for cancer and other illnesses. Mr. 
Tighe misrepresented the quality of Med Prep's drug processing and 
repackaging operations to increase market share, and he engaged in 
substandard practices to save money and increase his profits. Relying 
on these misrepresentations and omissions, healthcare providers paid 
Med Prep approximately $34,970,881 for its services between 
approximately 2007 and 2012.
    Based on his conviction, FDA sent Mr. Tighe by certified mail on 
October 25, 2019, a notice proposing to permanently debar him from 
providing services in any capacity to a person that has an approved or 
pending drug product application. The proposal was based on a finding, 
under section 306(a)(2)(B) of the FD&C Act, that Mr. Tighe was 
convicted, as set forth in section 306(l)(1) of the FD&C Act, of a 
felony under Federal law for conduct relating to the regulation of a 
drug product under the FD&C Act. The proposal also offered Mr. Tighe an 
opportunity to request a hearing, providing him 30 days from the date 
of receipt of the letter in which to file the request, and advised him 
that failure to file a timely request for a hearing constituted a 
waiver of the opportunity for a hearing and of any contentions 
concerning this action. Mr. Tighe received the proposal on October 31, 
2019. Mr. Tighe did not request a hearing and has, therefore, waived 
his opportunity for a hearing and any contentions concerning his 
debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal 
Food Operations, under section 306(a)(2)(B) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Gerald 
Tighe has been convicted of a felony under Federal law for conduct 
relating to the regulation of a drug product under the FD&C Act.
    As a result of the foregoing finding, Gerald Tighe is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application under sections 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), applicable (see 
DATES) (see sections 201(dd) and 306(c)(1)(B) and (c)(2)(A)(ii) of the 
FD&C Act (21 U.S.C. 321(dd) and 335a(c)(1)(B) and (c)(2)(A)(ii))). Any 
person with an approved or pending drug product application who 
knowingly employs or retains as a consultant or contractor, or 
otherwise uses in any capacity the services of Gerald Tighe during his 
debarment, will be subject to civil money penalties (section 307(a)(6) 
of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Tighe provides services 
in any capacity to a person with an approved or pending drug product 
application during his period of debarment, he will be subject to civil 
money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA 
will not accept or review any abbreviated new drug applications from 
Mr. Tighe during his period of debarment (section 306(c)(1)(B) of the 
FD&C Act).
    Any application by Mr. Tighe for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2019-N-3591 and sent to the Dockets Management Staff 
(see ADDRESSES). You can submit only one copy for all such submissions. 
The public availability of information in these submissions is governed 
by 21 CFR 10.20.
    Publicly available submissions may be seen in the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05714 Filed 3-18-20; 8:45 am]
 BILLING CODE 4164-01-P


