July 14, 2000: Minutes of the Joint Meeting of Nonprescription Drugs Advisory Committee and the Endocrinological and Metabolic Drugs Advisory Committee
PravacholÒ NDA 21-198, pravastatin sodium, 10mg, Bristol Myers Squibb
Proposed Indication: to treat individuals with total cholesterol levels of 200-240mg /dl and low density lipoprotein levels (LDL) over 130mg /dl. The proposed indication is for men over 40 years of age and postmenopausal women who do not have established cardiovascular disease or diabetes.
The meeting was held at the Holiday Inn, Bethesda, MD. Prior to the meeting, the members, consultants and guests had reviewed background material from the FDA and from BMS. In order for the public to be informed, the background material was also available on the Dockets page the day before the meeting. There were approximately 250 persons in attendance. The meeting started at 8 a.m. and ended at 4:30 p.m.
NDAC Members Present: Eric Brass, M.D., Ph.D., Chair, Richard Neill, M.D., Edward Krenzelok, Pharm.D., Edwin Gilliam, Ph.D., Julie Johnson, Pharm.D.,
Donald Uden, Pharm.D., Henry Williams, M.D. , George Blewitt, M.D.,(non voting)
NDAC Members Absent: Hari Sachs, M.D., Louis Cantilena, M.D., Ph.D., Francis Lam, Pharm.D.
E&M Members Present: Jaime Davidson, M.D., Barbara Luckert, M.D.,
Janet Silverstein, M.D., Marie Gelato, M.D., Ph.D., Deborah Grady, M.D., M.P.H., William Tamborlane, M.D.,
E&M Absent: Henry Bone, M.D., Thomas Aoki, M.D., Allan Sampson, Ph.D.,
Jules Hirsch, M.D.
Consultants: Janet Elashoff, M.D., Mark Molitch, M.D,
Non voting Guest: Luther T. Clark, M.D.
FDA Participants: Robert DeLap, M.D., Ph.D., Charley Ganley, M.D., Linda Katz, M.D., John Jenkins, M.D., David Orloff, M.D., Mary Parks, M.D., Daiva Shetty, M.D., Karen Lechter, J.D., Ph.D.
Overview of BMS Presentation:
Mark Kreston introduced the program. Jerome Cohen, M.D., gave an overview of cardiovascular risk factors and the OTC rationale. Rene Belder, M.D., reviewed pravachol safety followed by Carola Friedman, M.D., who reviewed the clinical data. Patricia Kriger described the plans for education in post market studies.
Overview of FDA’s Presentation:
David Orloff, M.D., gave an opening overview of the issues. Mary H. Parks, M.D. gave the medical review. Daiva Shetty, M. D., described the actual use trials. Karen Lechter, J.D., Ph.D critiqued the label comprehension study. Linda Katz. M.D., MPH, gave the charge to the committee.
Efficacy and Safety in the Proposed Target Population
The committee altered the question and broke it into the following two:
a. Based on the data submitted in the NDA, has the sponsor adequately demonstrated a clinical benefit, (defined as lowering of LDL) with pravastatin 10 mg in the target population?
Yes=13 No=0 Abstain=1
A verbatim transcript of this meeting will be available on the FDA’s Dockets Management Branch Website approximately 30 days after the meeting. The address is HTTP://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
I certify that I attended the July 14, 2000 meeting of the Joint Meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Advisory Committee and that these minutes accurately reflect what transpired.
Sandra Titus, Ph.D. Date Eric Brass, M.D., Ph.D. Date
Executive Secretary, NDAC Chair, NDAC