FDA introduction 美国FDA简介.pptVIP

FDA - INTRODUCTION TO DRUG REGULATION Edward P. Richards Director, Program in Law, Science, and Public Health Louisiana State University Law Center Basic Mission Safety Efficacy Drugs Medical Devices Truthful Labeling Adulteration Misbranding FDAs Structure and Organization The Commissioner President Appoints, Senate Confirms 4th Tier in HHS Not an Independent Agency Insulation From Politics (Old Days) Few Political Appointees Scientific Basis of Its Decisions Visibility Protects It From Presidential Pressure Does Congress Defer to the FDA? No, Congress Constantly Reviews the Agency in Committee Meetings Why? Lots of Money Lots of Powerful Interests Drugs, Food Labeling Food and Drug Cranks What Does the FDA Regulate? Food (with Agriculture Department) Drugs Biologics Medical Devices Cosmetics Anything That Produces Dangerous Radiation 25% of the Consumer Dollar Food Supplements Did Regulate Food Supplements and “Health Foods” Began to Crack Down on Unproven Claims and Raise Questions about Safety Congress was Lobbied (Oren Hatch) Pulled the FDA Authority to Regulate Food Supplements Can Only Act on Evidence of Post-Marketing Harm No Pre-Market Approval What Is a Drug? 201(g) (A) Articles Recognized in the Official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or Any Supplement to Any of Them Does the FDA Really Treat Every Thing in These As Drugs? What Is a Drug? 201(g) (B) Articles Intended for Use in the Diagnosis, Cure, Mitigation, Treatment, or Prevention of Disease in Man or Other Animals How Do You Judge This? Manufacturer or Sellers Representations Are These Limited to Labels and Advertising? No, Sec Info Is an Example Can Consider Consumer Expectations in Exceptional Circumstances What Is a Drug? 201(g) (C) Articles (Other Than Food) Intended to Affect the Structure or Any Function of the Body of Man or Other Animals Do They Really Mean This? (Guns, Bullets) (D) Articles In