[Federal Register Volume 77, Number 178 (Thursday, September 13, 2012)]
[Notices]
[Pages 56646-56647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22606]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0355]
Wayne E. Spencer: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
permanently debarring Wayne E. Spencer from providing services in any
capacity to a person that has an approved or pending drug product
application. We base this order on a finding that Dr. Spencer was
convicted of a felony under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of a drug product under the FD&C Act. Dr. Spencer was given
notice of the proposed permanent debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation, but
failed to respond. Dr. Spencer's failure to respond constitutes a
waiver of his right to a hearing concerning this action.
DATES: This order is effective September 13, 2012.
ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Compliance
Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs,
Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857,
301-796-4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A))
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 development or
[[Page 56647]]
approval, including the process for development or approval, of a drug
product under the FD&C Act.
On March 7, 2012, the U.S. District Court for the District of
Kansas entered judgment against Dr. Spencer after he entered a guilty
plea to, among others, a felony count of failing to prepare and
maintain records required under section 505(i) of the FD&C Act, with
the intent to defraud and mislead, in violation of sections 301(e) and
303(a)(2) of the FD&C Act (21 U.S.C. 331(e), 333(a)(2), and 18 U.S.C.
2).
FDA's finding that debarment is appropriate is based on the felony
conviction referenced herein for conduct relating to the development or
approval, including the process for development or approval, of a drug
product under the FD&C Act.
The factual basis for this conviction is as follows: Dr. Spencer
was a licensed medical doctor practicing medicine in the District of
Kansas. Schering/Plough was a pharmaceutical company engaged in
developing and marketing pharmaceutical products. In or about July
2009, Schering/Plough chose Lee Research Institute, Dr. Spencer's
employer, to perform a clinical study known as ``A 28-Day Study
Evaluating the Safety of Ragweed Sublingual Tablet in Adult Subjects 50
Years of Age and Older with Ragweed-Induced Rhino Conjunctivitis.'' Dr.
Spencer was the principal investigator for the clinical study.
Before beginning the clinical study, FDA required Schering/Plough
to provide the Agency with a study protocol. The study protocol
contained information about how the clinical study would be conducted,
where studies would be done and by whom, how the drug's safety would be
evaluated, and what findings would require the study to be changed or
halted. According to the study protocol, each subject had to be 50
years of age or older. Additionally, the study protocol excluded
subjects who were a member or a family member of the personnel of the
investigational or sponsor staff directly involved with the clinical
trial. Under section 505(i) of the FD&C Act (21 U.S.C. 355(i)) and 21
CFR 312.62(b), Dr. Spencer was required to maintain adequate and
accurate case histories on each individual who was administered
Schering/Plough's investigational drug.
Beginning in or about January 2010, and continuing through in or
about May 2010, Dr. Spencer, with the intent to defraud and mislead,
failed to prepare and maintain the records required described above.
Specifically, Dr. Spencer falsified the birth dates of two participants
such that they appeared to be older than 50 years of age; falsely
indicated that physical examinations had been performed when they had
not been performed; and indicated on required forms that two
participants met the inclusion criteria and had no reasons for
exclusion when he knew that the participants did not meet the inclusion
criteria of age and should have been excluded as employees of Lee
Research Institute.
As a result of his conviction, on June 20, 2012, FDA sent Dr.
Spencer a notice by certified mail 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)(A) of the FD&C Act (21 U.S.C.
335a(a)(2)(A)), that Dr. Spencer was convicted of a felony under
Federal law for conduct relating to the development or approval,
including the process for development or approval, of a drug product
under the FD&C Act.
The proposal also offered Dr. Spencer 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 request a
hearing constituted a waiver of the opportunity for a hearing and of
any contentions concerning this action. Dr. Spencer received the
proposal on June 25, 2012. He failed to respond and has, therefore,
waived his opportunity for a hearing and has waived any contentions
concerning his debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(a)(2)(A) of the FD&C Act (21
U.S.C. 335a(a)(2)(A)), under authority delegated to the Director (Staff
Manual Guide 1410.35), finds that Wayne E. Spencer has been convicted
of a felony under Federal law for conduct relating to the development
or approval, including the process for development or approval, of a
drug product under the FD&C Act.
As a result of the foregoing finding, Wayne E. Spencer 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 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 (see DATES) (see section 306(c)(1)(B), (c)(2)(A)(ii), and
201(dd) of the FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii), and
321(dd))). Any person with an approved or pending drug product
application who knowingly employs or retains as a consultant or
contractor, or otherwise uses the services of Dr. Spencer, in any
capacity during Dr. Spencer's 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 Dr. Spencer 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 (21 U.S.C. 335b(a)(7))). In addition, FDA
will not accept or review any abbreviated new drug applications
submitted by or with the assistance of Dr. Spencer during his period of
debarment (section 306(c)(1)(A) of the FD&C Act (21 U.S.C.
335a(c)(1)(A))).
Any application by Dr. Spencer for special termination of debarment
under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) should
be identified with Docket No. FDA-2012-N-0355 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.
Dated: September 4, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-22606 Filed 9-12-12; 8:45 am]
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