July 13, 2000: Minutes of the Joint Meeting of Nonprescription Drugs Advisory Committeee and the Endocrinological and Metabolic Drugs Advisory Committee
MevacorÒ NDA 21-213, lovastatin, 10mg, Merck and Company
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 Merck. 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 275 persons in attendance. The meeting started at 8 a.m. and ended at 5:30 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.,
Marie Gelato, M.D., Ph.D., Deborah Grady, M.D., M.P.H., William Tamborlane, M.D.
E&M Members Absent: Henry Bone, M.D., Thomas Aoki, M.D., Allan Sampson, Ph.D., Janet Silverstein, M.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 Temple, M.D., 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., Andrea Leonard Segal, M.D., Karen Lechter, J.D., Ph.D.
Open Public Hearing:
The following individuals made statements:
1. Rene F. Rodriguez, M.D., Inter-American College of Physicians and Surgeons
2. Waine Kong, Ph.D., J.D., CEO, Association of Black Cardiologists
3. Debra Judelson, M.D., American Medical Women’s Association
4. Sidney Wolfe, M.D., Director, Public Citizen Health Research Group
5. Thomas Pearson, M.D., Ph.D., Chair, Department of Community and Preventive Medicine, University of Rochester, N.Y.
9. Brett Kay, Program Associate, National Consumers League, Washington D.C.
10. Bernhard Kaston, M.D., Quest Diagnostics Incorporated
11. Warren Pinckert, CEO, Cholestech Corporation
Overview of Merck’s Presentation:
Eve Slater, M.D., presented the introduction. Polly Beere, M.D., Ph. D. discussed the benefit of lovastatin in an OTC Population. Scott Korn, M.D. presented on the safety of lovastatin. Edwin Hemwall, PhD concluded with a presentation on Label Development and Consumer Behavior .
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. Andrea Leonard Segal, 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 lovastatin 10 mg in the target population?
b. Based on the data submitted in the NDA, has the sponsor adequately demonstrated a clinical benefit, (defined as reduction of cardiovascular events) with lovastatin 10 mg in the target population?
Yes=1 No=11 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 13, 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