[Federal Register Volume 82, Number 244 (Thursday, December 21, 2017)]
[Notices]
[Pages 60611-60612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27485]



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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.

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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

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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]
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