Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Rockville MD 20857
NOTICE OF OPPORTUNITY FOR A HEARING
CERTIFIED MAIL-RESTRICTED DELIVERY
RETURN RECEIPT REQUESTED
JUN 28 1999
Howard E. Bogard, Esq.
Burr & Forman, L.L.P.
Post Office Box 83079
Birmingham, Alabama 35283-0719
Dear Mr. Bogard:
The Center for Drug Evaluation and Research (the Center) of the Food and Drug Administration (FDA) has information indicating that your client, Richard M. Allman, M.D., repeatedly and/or deliberately violated federal regulations in his capacity as an investigator in clinical studies with investigational new drugs. These violations provide the basis for withdrawal of Dr. Allman's eligibility as a clinical investigator to receive investigational new drugs.
The Center's findings are based on information obtained between June 10 and October 9, 1997, during FDA's inspection of Dr. Allman's conduct as the investigator of record for the following clinical studies:
1.. A Double-Blind, Randomized, Placebo-Controlled study of Thermazene Cream (1% silver sulfadiazine) in Chronic Wounds, conducted for Sherwood Medical Company [Protocol # (b)(4)].
2. Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Safety and Efficacy of Topically Applied (b)(4) in the Treatment of Grade III and IV Pressure Ulcers, conducted for (b)(4). [Protocol #(b)(4)
3. A Multicenter Randomized Clinical Investigation of (b)(4) in Patients with Pressure Ulcers, conducted for (b)(4) [Protocol #(b)(4)
4. Phase II Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel Study of the Safety and Efficacy of a (b)(4) in the Treatment of Pressure Ulcers, conducted for (b)(4). [Protocol # (b)(4).
Pursuant to section 312.70(a) of Title 21 of the Code of Federal Regulations (CFR) , the Center informed Dr. Allman, by letter titled "Notice of Initiation of Disqualification Proceedings and Opportunity to Explain" (NIDPOE) dated July 10, 1998, of the specific matters complained of and offered him an opportunity to respond to them- in writing or at an informal conference. The NIDPOE also offered Dr. Allman the option of entering into a consent agreement with the FDA, thereby terminating the administrative proceedings against him.
In response to the NIDPOE, you, as the attorney representing Dr. Allman, submitted a written explanation to the matters complained of in the NIDPOE. FDA has reviewed the explanation and accepts Dr. Allman's explanation for the following matters which pertain to protocol #(b)(4) sponsored by Sherwood Medical Company:
1. Item I.C.4. on page 4 of the NIDPOE, regarding exclusion of the subject with BUN >50 mg/dl.
2. Items I.D.1 through I.D.5. on pages 4 and 5 of the NIDPOE, regarding the preparation and maintenance of adequate and accurate records for the clinical study.
The Center has concluded that Dr. Allman's written explanation for the remaining matters is unacceptable because it fails to adequately address the violations set forth below. Item I.D.3. in the NIDPOE is removed as it is included under item I.A. of the NIDPOE.
Accordingly, Dr. Allman is being offered an opportunity for a regulatory hearing pursuant to 21 CFR Parts 16 and 312, to determine whether he is entitled to receive investigational new drugs. As you are aware, Dr. Allman has the right to be advised and represented by counsel at all times. Any regulatory hearing on this matter will be governed by the regulations in 21 CFR Part 16 and FDA's guidelines on electronic media coverage of administrative proceedings, 21 CFR Part 10, Subpart C. Enclosed you will find copies of these regulations. A listing of the specific violations follows. These are matters that will be considered at the regulatory hearing. Applicable provisions of the CFR are cited for each violation.
I. For Protocol Number: (b)(4) of the investigational drug Thermazene Cream 1%.
A. Dr. Allman failed to obtain legally effective informed consent for 21 of the 34 subjects in his study in violation of 21 CFR sections 50.20, 50.25, 50.27, and 312.60.
B. Dr. Allman failed to inform the institutional review board (IRB) of the details of-the consent process used in his study in violation of 21 CFR sections 50.27, and 312.66.
C. Dr. Allman failed to conduct the study in accordance with the approved protocol in violation of 21 CFR sections 312.53 (c) (1) (vi) (a), and 312.60, and did not obtain IRB approval for protocol amendments before making changes in the (b)(4) research in violation of 21 CFR section 312.66.
1. The approved protocol (section D.1.e) specified that the area of a wound eligible for inclusion in the study must be at least (b)(4). Twenty-one of the forty-eight wounds in Dr. Allman's study were ineligible for the study because they had surface areas less than (b)(4).
2. The study protocol specifically excluded patients who had SSD (Thermazene) wound care treatment within the preceding 14 days (section D.2.a). Records document that the subject with wound #(b)(6) had been treated with SSD within 14 days prior to study entry.
II. Dr. Allman failed to obtain legally effective informed consent for the following subjects in violation of 21 CFR sections 50.20, 50.25, 50.27, and 312.60:
A. subject #(b)(4) who participated in the (b)(4) study sponsored by (b)(4) [Protocol (b)(4)
B. Subject #(b)(6) who participated in the study evaluating (b)(4) treatment of pressure ulcers sponsored by (b)(4). [Protocol #(b)(4)]
C. Subjects #(b)(6), #(b)(6), (b)(6), and #(b)(6) who participated in the study evaluating (b)(4) pressure ulcers, sponsored by (b)(4) [Protocol #(b)(4)].
Dr. Allman's request for a hearing must be made, in writing, within ten (10) business 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, Maryland 20857, Telephone (301) 827-0425, FAX (301) 827-0482. If no response to this letter is received by that time, Dr. Allman will be deemed to have waived any right to a regulatory hearing, and a decision in this matter will be made without a hearing based on the facts available to FDA. No hearing will be held.
A request for a hearing may not rest upon mere allegations or denials but must present specific facts showing that there is a genuine and substantial issue of fact that warrants a hearing. Pursuant to 21 CFR 16.26, a request for a hearing may be denied, in whole or part, if the Commissioner or his delegate determines that no genuine and substantial issue of fact had been raised by the material submitted. A hearing will not be granted on issues of policy or law. Written notice of a determination of summary judgement will be provided, explaining the reasons for denial of the hearing.
If Dr. Allman wishes to respond but does not desire a hearing, he should contact Dr. McCormack within the time period specified above and send a written response containing his reply. The letter should state that Dr. Allman waives his right to a haring that he wants a decision on the matter to be based on his written response and other information available to FDA.
FDA's offer to enter into a consent agreement, attached to the NIDPOE dated July 10, 1998, remains available. Entering into a consent agreement would terminate the administrative procedures, but would not preclude the possibility of a corollary judicial proceeding.
No final decision by FDA has been made at this time on Dr. Allman's eligibility to continue to receive investigational new drugs. Moreover, there will be no prejudgement of this matter if Dr. Allman declines to enter into a consent agreement and decides instead either to request a regulatory hearing or to request that the decision be based on information currently available to FDA.
Please inform Dr. McCormack within ten (10) business days of whether Dr. Allman wishes to request a hearing or to have this matter resolved by consent agreement or information available to FDA.
Dennis E. Baker
Associate Commissioner for