Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Rockville MD 20857|
APR 2 1997
NOTICE OF OPPORTUNITY OF HEARING
Return Receipt Requested
Charles M. Singleton, M.D.
1301 McCullough Street, Suite 600
San Antonio, Texas 78212
Dear Dr. Singleton:
The Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) has information indicating that you failed to maintain adequate and accurate records of all observations, failed to maintain adequate drug accountability records, and failed to adequately identify your study site and repeatedly and/or deliberately violated federal regulations in your conduct of a clinical trial (Protocol No. 654D-321) with the Wyeth Ayerst Research investigational drug Etodolac Extended Release.
Pursuant to section 312.70(a) of Title 21, Code of Federal Regulations (CFR), CDER informed you, by letter dated July 2, 1996, of the specific matters complained of and offered you an opportunity to respond in writing or at an informal conference. That same letter gave you the option of entering into a consent agreement with the agency, thereby terminating any administrative proceeding against you. By not responding to the letter of July 2, 1996, you waived your opportunity for an informal conference and for a written response.
Pursuant to sections 16.24 and 312.70(a) of Title 21 Code of Federal Regulations, you are hereby notified of your opportunity for a regulatory hearing before the Agency to determine whether you are entitled to receive investigational new drugs. Under Federal regulations you have the right to be advised and represented by counsel at all times. Because of the seriousness of this matter, you are strongly urged to exercise this right. Any public hearing on this matter will be governed by the regulations in Title 21 CFR Part 16 and the Agency's guidelines on electronic media coverage of public administrative proceedings, Title 21 CFR Part 10, Subpart C. Copies of those regulations are enclosed.
The matters to be considered at the regulatory hearing are set forth in sections 1, 2 and 3 below.
1. Failure to maintain adequate and accurate records of all observations and other data pertinent to the investigation on each individual treated with the investigational drug or employed as a control in the investigation, as required under 21 CFR Part 312.62 (b), in that:
a. The source documents were not available for FDA inspection for 16 of the 21 subjects enrolled into your study (e.g., laboratory reports, x-ray films and radiology reports, medical records, electrocardiogram tracings, ESR (Westergren) results, urine dip stick results for salicylates, history of positive therapeutic response to non-steroidial anti-inflammatory drugs).
b. The patient diaries were not available for inspection for any of the 21 subjects.
c. Copies of the original case report forms were not available for inspection for any of the 21 subjects who participated in your study.
2. Failure to maintain adequate drug accountability records as required under 21 CFR 312.62 (a), in that:
a. You did not maintain documentation to support the receipt of the Patient Package from Wyeth Ayerst Research that contained the study medication administered to subject #31 (randomization #91).
b. You failed to maintain records of receipt from Wyeth Ayerst Research of the 300 mg Etodolac Capsules that were administered to the study's subjects.
3. You failed to identify on the FDA Form 1572, as required under 21 CFR 312.53 (c)(1)(iii), the Arthritis Clinic of South Texas, 305 E. Euclid Avenue, Suite #101, San Antonio, Texas 78212, as a study site. You enrolled five subjects in the study at this site.
Your response to this letter should be made within fifteen (15) calendar days after receipt of this letter and directed to Dr. James F. McCormack, Coordinator, Bioresearch Monitoring Program, Office of Enforcement, Division of Compliance Policy (HFC-230), 5600 Fishers Lane, Rockville, MD 20857, Telephone (301) 827-0425, FAX (301) 827-0482. If no response to this letter is received by that time, you will be deemed to have waived any right to a regulatory hearing, and a decision in this matter will be made based on the facts available to the agency.
You may respond to this letter by submitting a written request for a regulatory hearing. If you wish to respond but do not want to avail yourself of the opportunity for a hearing, you should contact Dr. McCormack within the time allowance specified above and send a written response containing your reply and stating that you waive any right to a hearing and that you want a decision on the matter to be made based on your response and other information available to the agency. Your written response should be sent no later than thirty (30) calendar days after the receipt of this letter.
The agency's offer to enter into a consent agreement remains available. I emphasize that no final decision by FDA has been made at this time on your eligibility to continue to use investigational drugs. Moreover, there will be no prejudgment of this matter if you decline to enter into the consent agreement and decide instead either" to request a regulatory hearing or to request that the decision be based on information currently available to the agency. Entering into a consent agreement would terminate the administrative procedures, but would not preclude the possibility of a corollary judicial proceeding.
Ronald G. Chesemore
Associate Commissioner for