Joint Meeting of the

Nonprescription Drugs Advisory Committee

and the

Endocrinologic and Metabolic Drugs Advisory Committee

January 14, 2005


Open Public Hearing

Open Public Hearing Speakers [htm] [pdf] [ppt]

Should Statins Be Approved for Over-the-Counter, Laurie Tansman, MS, RD, CDN (HTM) (PPT)

Are OTC Statins the Right Option for America?, James McKenney (HTM) (PPT)

Presentation by Impact Health, Stewart Levy, R.Ph (HTM) (PPT)

Human Teratogenicity of Lovastatin: A Safety Concern?, Dr. Robin Edison, MD, MPH and Dr. Maximilian Muenke, MD (HTM) (PPT)

Association of Black Cardiologists, Inc. 2003 Annual Report, Dr. John Barnes (PDF)

The Serious Public Health Dangers of Prescription-to-OTC Switch of Lovastatin, Dr. Sidney Wolfe, MD (PDF)

The Safety and Efficacy of Mevacor as an OTC Product, Bob Dufour, R.Ph, Wal-Mart Stores, Inc. (PDF)

APhA Task Force, Dr. Jan Engle, Pharmd, FAPhA, American Pharmacists Assoc. (PPT)

Presentation Regarding Mevocor OTC?, Tom Scherer, Civil Rights Activist, Law Student (PDF)

Presentation by Suzanne Hughes (PDF)

Presentation by the National Consumers League (NCL) (PDF)

Support for FDA approval of OTC Statin Drugs, Dr. Penny Kris-Etherton, PhD, RD, Penn State University (PDF)

American Society of Health-System Pharmacists Statement on the Over-the-Counter Availability of Statins, Dr. William Greene, PharmD BCPS, FASHP (PDF)

Presentation by the National Lipid Association, Dr. James McKenney (PDF)

Presentation by the American Pharmacists Association, Dr. John Gans, PharmD (PDF)

Presentation by CVS Pharmacy, Thomas Davis, RPh (PDF)

Proposing Over-the-Counter (OTC) Use of Lovastatin (Mevacor), Dr. Anthony Means, PhD, The Endocrine Society (PDF)

Presentation by the American Association of Clinical Endocrinologists (AACE), Dr. Carlos Hamilton, Jr., MD, FACE (PDF)

Presentation by Pfizer Global Pharmaceuticals, Dr. Cathryn Clary, MD (PDF)

Presentation by the Teva Pharmaceuticals USA, Inc., Philip Erickson, RPh (PDF)

Presentation the US Consumer Product Safety Commission, Dr. Suzanne Barone, PhD (PDF)