82 FR 60611 - Keith J. Pierce: Debarment Order
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 244 (December 21, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 244 (December 21, 2017)
| Page Range | 60611-60612 | |
| FR Document | 2017-27485 |
[Federal Register Volume 82, Number 244 (Thursday, December 21, 2017)] [Notices] [Pages 60611-60612] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27485] [[Page 60611]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1277] Keith J. Pierce: Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Dr. Keith J. Pierce for a period of 5 years 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 Dr. Pierce was convicted of a misdemeanor 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. Pierce was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Pierce failed to request a hearing. Dr. Pierce's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action. DATES: This order is applicable December 21, 2017. 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: Kenny Shade, Division of Enforcement, Office of Enforcement and Import Operations, Office of Regulatory Affairs (ELEM 4144), Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-4640. SUPPLEMENTARY INFORMATION: I. Background Section 306(b)(2)(B) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)) permits debarment of an individual if FDA finds that the individual has been convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. On March 3, 2016, the U.S. District Court for the Eastern District of Michigan entered judgment against Dr. Pierce for one count of failure to maintain records required under section 505(i) of the FD&C Act (21 U.S.C. 355(i)) and FDA's regulations at Sec. 312.62(b) (21 CFR 312.62(b)), a Federal misdemeanor offense under the FD&C Act sections 301(e) and 303(a) (21 U.S.C. 331(e) and 333(a)(1)). FDA's finding that the debarment is appropriate is based on the misdemeanor conviction referenced herein. The factual basis for this conviction was as follows: At the time the conduct underlying the conviction occurred, Dr. Pierce was licensed to practice medicine under the laws of Michigan. In 2003, Aventis Pharmaceuticals operated a clinical trial for KETEK (telithromycin), investigating its use as a drug to treat acute maxillary sinusitis (AMS). This clinical trial was conducted pursuant to an investigational new drug application (IND) held by Aventis Pharmaceuticals, and was therefore subject to FDA's oversight and jurisdiction. (see section 505(i) of the FD&C Act and part 312 (21 CFR part 312)). Between approximately April and July 2003, Dr. Pierce served as an investigator under the IND by conducting clinical testing of KETEK on patients in his medical practice. FDA's regulations at part 312 require, among other things, that clinical investigators prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation. The failure to establish or maintain any record required under section 505(i) of the FD&C Act is a prohibited act under sections 301(e) and 303(a) of the FD&C Act. Records required under section 505(i) of the FD&C Act include records required to be kept under FDA's regulations at Sec. 312.62. Between approximately April and July 2003, Dr. Pierce failed to maintain adequate and accurate case histories on each individual administered the investigational drug or employed as a control in the investigation, as required by Sec. 312.62. In particular, Dr. Pierce failed to adequately and accurately document information about trial participants' previous research participation and relevant medical histories. As a result of his conviction, on July 17, 2017, FDA sent Dr. Pierce a notice by certified mail proposing to debar him for a period of 5 years 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(b)(2)(B) of the FD&C Act, that Dr. Pierce was convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. FDA determined that Dr. Pierce's misdemeanor conviction was for illegal conduct relating to the development or approval of KETEK (telithromycin) for the treatment of AMS in that he failed to maintain adequate and accurate case histories for individuals in his clinical investigations. FDA finds that Dr. Pierce's conduct undermined the Agency's ability to rely on clinical data obtained in the process of developing new drugs for approval and therefore related to the development or approval of a drug product under the FD&C Act. The proposal also offered Dr. Pierce 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. The proposal was received on July 24, 2017. Dr. Pierce failed to respond within the timeframe prescribed by regulation 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 Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs, under section 306(b)(2)(B) of the FD&C Act, under authority delegated to him (Staff Manual Guide 1410.35), finds that Dr. Keith J. Pierce has been convicted of a misdemeanor 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, Dr. Keith J. Pierce is debarred for 5 years 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), effective (see DATES) (see sections 201(dd), 306(c)(1)(B), and 306(c)(2)(A)(iii) of the FD&C Act (21 U.S.C. 321(dd), 335a(c)(1)(B), and 335a(c)(2)(A)(iii)). 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. Pierce, in any capacity 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 Dr. Pierce provides services in any capacity to a person with [[Page 60612]] 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 Dr. Pierce during his period of debarment (section 306(c)(1)(B) of the FD&C Act). Any application by Dr. Pierce for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA-2017-N-1277 and sent to the Dockets Management Staff (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by Sec. 10.20. Publicly available submissions may be seen in the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. Dated: December 14, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27485 Filed 12-20-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 244 / Thursday, December 21, 2017 / Notices 60611
DEPARTMENT OF HEALTH AND regulations at § 312.62(b) (21 CFR including the process for development
HUMAN SERVICES 312.62(b)), a Federal misdemeanor or approval, of any drug product under
offense under the FD&C Act sections the FD&C Act. FDA determined that Dr.
Food and Drug Administration 301(e) and 303(a) (21 U.S.C. 331(e) and Pierce’s misdemeanor conviction was
[Docket No. FDA–2017–N–1277] 333(a)(1)). for illegal conduct relating to the
FDA’s finding that the debarment is development or approval of KETEK
Keith J. Pierce: Debarment Order appropriate is based on the (telithromycin) for the treatment of AMS
misdemeanor conviction referenced in that he failed to maintain adequate
AGENCY: Food and Drug Administration, herein. The factual basis for this and accurate case histories for
HHS. conviction was as follows: At the time individuals in his clinical
ACTION: Notice. the conduct underlying the conviction investigations. FDA finds that Dr.
occurred, Dr. Pierce was licensed to Pierce’s conduct undermined the
SUMMARY: The U.S. Food and Drug practice medicine under the laws of Agency’s ability to rely on clinical data
Administration (FDA or Agency) is Michigan. In 2003, Aventis obtained in the process of developing
issuing an order under the Federal Pharmaceuticals operated a clinical trial new drugs for approval and therefore
Food, Drug, and Cosmetic Act (the for KETEK (telithromycin), investigating related to the development or approval
FD&C Act) debarring Dr. Keith J. Pierce its use as a drug to treat acute maxillary of a drug product under the FD&C Act.
for a period of 5 years from providing sinusitis (AMS). This clinical trial was The proposal also offered Dr. Pierce an
services in any capacity to a person that conducted pursuant to an opportunity to request a hearing,
has an approved or pending drug investigational new drug application providing him 30 days from the date of
product application. FDA bases this (IND) held by Aventis Pharmaceuticals, receipt of the letter in which to file the
order on a finding that Dr. Pierce was and was therefore subject to FDA’s request, and advised him that failure to
convicted of a misdemeanor under oversight and jurisdiction. (see section request a hearing constituted a waiver of
Federal law for conduct relating to the 505(i) of the FD&C Act and part 312 (21 the opportunity for a hearing and of any
development or approval, including the CFR part 312)). Between approximately contentions concerning this action. The
process for development or approval, of April and July 2003, Dr. Pierce served proposal was received on July 24, 2017.
a drug product under the FD&C Act. Dr. as an investigator under the IND by Dr. Pierce failed to respond within the
Pierce was given notice of the proposed conducting clinical testing of KETEK on timeframe prescribed by regulation and
debarment and an opportunity to patients in his medical practice. FDA’s has, therefore, waived his opportunity
request a hearing within the timeframe regulations at part 312 require, among for a hearing and any contentions
prescribed by regulation. Dr. Pierce other things, that clinical investigators concerning his debarment (21 CFR part
failed to request a hearing. Dr. Pierce’s prepare and maintain adequate and 12).
failure to request a hearing constitutes a accurate case histories that record all
waiver of his right to a hearing observations and other data pertinent to II. Findings and Order
concerning this action. the investigation on each individual Therefore, the Director, Office of
DATES: This order is applicable administered the investigational drug or Enforcement and Import Operations,
December 21, 2017. employed as a control in the Office of Regulatory Affairs, under
investigation. The failure to establish or section 306(b)(2)(B) of the FD&C Act,
ADDRESSES: Submit applications for
maintain any record required under under authority delegated to him (Staff
special termination of debarment to the
section 505(i) of the FD&C Act is a Manual Guide 1410.35), finds that Dr.
Dockets Management Staff (HFA–305),
prohibited act under sections 301(e) and Keith J. Pierce has been convicted of a
Food and Drug Administration, 5630
303(a) of the FD&C Act. Records misdemeanor under Federal law for
Fishers Lane, Rm. 1061, Rockville, MD conduct relating to the development or
required under section 505(i) of the
20852. approval, including the process for
FD&C Act include records required to be
FOR FURTHER INFORMATION CONTACT: kept under FDA’s regulations at development or approval, of a drug
Kenny Shade, Division of Enforcement, § 312.62. Between approximately April product under the FD&C Act.
Office of Enforcement and Import and July 2003, Dr. Pierce failed to As a result of the foregoing finding,
Operations, Office of Regulatory Affairs maintain adequate and accurate case Dr. Keith J. Pierce is debarred for 5 years
(ELEM 4144), Food and Drug histories on each individual from providing services in any capacity
Administration, 12420 Parklawn Dr., administered the investigational drug or to a person with an approved or
Rockville, MD 20857, 301–796–4640. employed as a control in the pending drug product application under
SUPPLEMENTARY INFORMATION: investigation, as required by § 312.62. In sections 505, 512, or 802 of the FD&C
particular, Dr. Pierce failed to Act (21 U.S.C. 355, 360b, or 382), or
I. Background under section 351 of the Public Health
adequately and accurately document
Section 306(b)(2)(B) of the FD&C Act information about trial participants’ Service Act (42 U.S.C. 262), effective
(21 U.S.C. 335a(b)(2)(B)) permits previous research participation and (see DATES) (see sections 201(dd),
debarment of an individual if FDA finds relevant medical histories. 306(c)(1)(B), and 306(c)(2)(A)(iii) of the
that the individual has been convicted As a result of his conviction, on July FD&C Act (21 U.S.C. 321(dd),
of a misdemeanor under Federal law for 17, 2017, FDA sent Dr. Pierce a notice 335a(c)(1)(B), and 335a(c)(2)(A)(iii)).
conduct relating to the development or by certified mail proposing to debar him Any person with an approved or
approval, including the process for for a period of 5 years from providing pending drug product application who
development or approval, of any drug services in any capacity to a person that knowingly employs or retains as a
daltland on DSKBBV9HB2PROD with NOTICES
product under the FD&C Act. On March has an approved or pending drug consultant or contractor, or otherwise
3, 2016, the U.S. District Court for the product application. The proposal was uses the services of Dr. Pierce, in any
Eastern District of Michigan entered based on a finding, under section capacity during his debarment, will be
judgment against Dr. Pierce for one 306(b)(2)(B) of the FD&C Act, that Dr. subject to civil money penalties (section
count of failure to maintain records Pierce was convicted of a misdemeanor 307(a)(6) of the FD&C Act (21 U.S.C.
required under section 505(i) of the under Federal law for conduct relating 335b(a)(6))). If Dr. Pierce provides
FD&C Act (21 U.S.C. 355(i)) and FDA’s to the development or approval, services in any capacity to a person with
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![60612 Federal Register / Vol. 82, No. 244 / Thursday, December 21, 2017 / Notices
an approved or pending drug product change to this notice. The matching adverse action against the individual, as
application during his period of program will be conducted for an initial required by 5 U.S.C. 552a(p).
debarment he will be subject to civil term of 18 months (approximately 4. Report the matching program to
money penalties (section 307(a)(7) of the January 13, 2018 through July 13, 2019) Congress and the OMB, in advance and
FD&C Act). In addition, FDA will not and within 3 months of expiration may annually, as required by 5 U.S.C.
accept or review any abbreviated new be renewed for up to 12 additional 552a(o) (2)(A)(i), (r), and (u)(3)(D).
drug applications from Dr. Pierce during months if the parties make no change to 5. Publish advance notice of the
his period of debarment (section the matching program and certify that matching program in the Federal
306(c)(1)(B) of the FD&C Act). the program has been conducted in Register as required by 5 U.S.C.
Any application by Dr. Pierce for compliance with the matching 552a(e)(12).
termination of debarment under section agreement. This matching program meets these
306(d)(1) of the FD&C Act should be ADDRESSES: Interested parties may requirements.
identified with Docket No. FDA–2017– submit written comments on this notice,
N–1277 and sent to the Dockets Participating Agencies
by mail or email, to Linda Boyer,
Management Staff (see ADDRESSES). All Director, Division of Federal Systems, Office of Child Support Enforcement
such submissions are to be filed in four Office of Child Support Enforcement, (OCSE) is the source agency, and state
copies. The public availability of Administration for Children and workforce agencies (SWAs)
information in these submissions is Families, by email at linda.boyer@ administering the Unemployment
governed by § 10.20. acf.hhs.gov, or by mail at Mary E. Compensation (UC) Program are the
Publicly available submissions may Switzer Building, 330 C Street SW, 5th recipient agencies.
be seen in the Dockets Management Floor, Washington, DC 20201.
Staff (see ADDRESSES) between 9 a.m. Authority for Conducting the Matching
Comments received will be available for Program
and 4 p.m., Monday through Friday. public inspection at this address from
Dated: December 14, 2017. 9:00 a.m. to 5:00 p.m. ET, Monday 42 U.S.C. 653(j)(8).
Leslie Kux, through Friday. Purpose(s)
Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT:
General questions about the matching The matching program provides each
[FR Doc. 2017–27485 Filed 12–20–17; 8:45 am]
program may be submitted to Linda SWA with new hire and quarterly wage
BILLING CODE 4164–01–P
Boyer, Director, Division of Federal information from OCSE’s National
Systems, Office of Child Support Directory of New Hires (NDNH) system
Enforcement, Administration for of records, pertaining to adult UC
DEPARTMENT OF HEALTH AND
Children and Families, by email at applicants and recipients, resulting from
HUMAN SERVICES
linda.boyer@acf.hhs.gov, by mail at comparing client name and Social
Privacy Act of 1974; Matching Program Mary E. Switzer Building, 330 C Street Security number combinations in the
SW, 5th Floor, Washington, DC 20201, SWA’s files to data in NDNH. The
AGENCY: Administration for Children match results assist the SWAs in
or by telephone at 202–401–5410.
and Families, Department of Health and establishing or verifying eligibility for
SUPPLEMENTARY INFORMATION: The
Human Services. assistance, reducing payment errors,
Privacy Act of 1974, as amended (5
ACTION: Notice of a new matching U.S.C. 552a), provides for certain and maintaining program integrity,
program. protections for individuals applying for including determining whether
duplicate participation exists or if the
SUMMARY: In accordance with subsection and receiving federal benefits. The law client resides in another state. The
(e)(12) of the Privacy Act of 1974, as governs the use of computer matching
SWAs may also use the NDNH
amended, the Department of Health and by federal agencies when records in a information for secondary purposes,
Human Services, Administration for system of records (meaning, records
about individual retrieved by personal such as updating UC recipients’
Children and Families, Office of Child reported participation in work activities,
Support Enforcement (HHS/ACF/ identifier) are matched with other
federal or state agency records. The updating recipients’ and their
OCSE), is providing notice of a re- employers’ contact information, and
established matching program between Privacy Act requires agencies involved
in a matching program to: administering the SWAs’ tax
OCSE and state workforce agencies compliance function.
1. Enter into a written agreement,
(SWAs) administering the
which must be prepared in accordance Categories of Individuals
Unemployment Compensation (UC)
with the Privacy Act, approved by the
Program. The matching program will The categories of individuals whose
Data Integrity Board of each
provide SWAs with new hire (i.e., information is involved in the matching
participating federal agency, provided to
employment status) and quarterly wage program are adult members of
Congress and the Office of Management
information from OCSE’s National households who receive or have applied
and Budget (OMB), and made available
Directory of New Hires (NDNH) system for UC benefits.
to the public, as required by 5 U.S.C.
of records, for the purpose of assisting
552a(o), (u)(3)(A), and (u)(4). Categories of Records
SWAs in preventing, detecting, and
2. Notify the individuals whose
addressing program violations and The categories of records involved in
information will be used in the
errors, and for related secondary the matching program are new hire and
matching program that the information
daltland on DSKBBV9HB2PROD with NOTICES
purposes. quarterly wage information. The specific
they provide is subject to verification
DATES: The deadline for comments on through matching, as required by 5 data elements that will be provided to
this notice is January 22, 2018. The re- U.S.C. 552a(o)(1)(D). OCSE in a SWA input file are:
established matching program will 3. Verify match findings before • Submitting state code (2-digit FIPS
commence not sooner than 30 days after suspending, terminating, reducing, or code)
publication of this notice, provided no making a final denial of an individual’s • Date stamp (input file transmission
comments are received that warrant a benefits or payments or taking other date)
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Document Created: 2018-10-25 11:00:46
Document Modified: 2018-10-25 11:00:46
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | This order is applicable December 21, 2017. | |
| Contact | Kenny Shade, Division of Enforcement, Office of Enforcement and Import Operations, Office of Regulatory Affairs (ELEM 4144), Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-4640. | |
| FR Citation | 82 FR 60611 |
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