Losing deference in the FDA's second century: judicial review, politics, and a diminished legacy of expertise.

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 939 R I. THE IMPORTANCE OF DEFERENCE . . . . . . . . . . . . . . . . . . . . . . . . . 941 R II. THE PARTICIPANTS IN THE DEFERENCE DEBATE . . . . . . . . . . . . 942 R III. THE SUPREME COURT’S DEFERENCE TO THE FDA . . . . . . . . . 943 R IV. THE TYPES OF DEFERENCE ENJOYED BY THE FDA . . . . . . . . . . 945 R V. HOW THE FDA EARNED ITS LEGACY OF DEFERENCE . . . . . . . 948 R VI. HOW THE FDA’S POWERS EVOLVED WITH DEFERENCE . . . . . 950 R VII. EXCEPTIONS TO THE DEFERENCE NORMS . . . . . . . . . . . . . . . . . . 952 R VIII. WHY THE INDUSTRY SHIFTED TO FAVOR DEFERENCE . . . . . . . 953 R IX. HOW THE FDA’S INVOLVEMENT IN THE ECONOMICS OF DRUG APPROVAL EXPANDED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 955 R X. THE EXERCISE OF PRESIDENTIAL POLICY THROUGH APPOINTEES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 959 R XI. CRITICISM OF THE FDA’S DECISION PROCESSES INTENSIFIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 962 R XII. CASE STUDY: POLITICS AND “PLAN B” . . . . . . . . . . . . . . . . . . . . . 964 R XIII. CASE STUDY: PREEMPTION OF STATE TORTS . . . . . . . . . . . . . . . 967 R XIV. PRESS COVERAGE OF THE FDA . . . . . . . . . . . . . . . . . . . . . . . . . . . 972 R XV. GROWING DENIALS OF DEFERENCE DURING THE BUSH ADMINISTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 973 R XVI. ARE COURTS INFLUENCED BY MEDIA PERCEPTIONS? . . . . . . . . 976 R XVII. WOULD A LESS POLITICIZED FDA REGAIN DEFERENCE? . . . . 977 R CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 978 R