ABSTRACT
Introduction ........................................................................................................... 2 The Evolution of the FDA-A Century of Laws and Policies ............................. 3
The History (1848-1979) ................................................................................. 3 1980 to the Present: AIDS, Orphans, Terrorism, Economic Incentives, and the Food and Drug Administration Safety and Innovation Act ................. 6 Biologics Price Competition and Innovation Act of 2009 ............................. 13 FDASIA ......................................................................................................... 14
Summary ............................................................................................................. 17 Agency Role and Organization ........................................................................... 17 New Drug Development and Approval Summary .............................................. 19 Preclinical Investigation ...................................................................................... 20 Investigational New Drug Application ................................................................ 20
Phase I ............................................................................................................ 22 Phase II ........................................................................................................... 22 Phase III ......................................................................................................... 22 New Drug Application ................................................................................... 22
Fast Track, Accelerated Approval, Priority Review, and “Breakthrough Therapy” Designations ........................................................................................ 24 Phase IV and Postmarketing Surveillance .......................................................... 26 Orphan Drugs ...................................................................................................... 26 Abbreviated New Drug Applications .................................................................. 26 OTC Regulations ................................................................................................. 28 Biologics ............................................................................................................. 29 Devices ................................................................................................................ 31 Regulating Drug and Device Marketing ............................................................. 33 Violations and Enforcement ................................................................................ 33 Conclusion .......................................................................................................... 35 Notes ................................................................................................................... 35 References ........................................................................................................... 36
The Food and Drug Administration (FDA), a single agency, regulates a trillion dollars of products, roughly 25 cents in every dollar spent, ranging from 80% of the US food supply to all human health-care products, prescription drugs and devices, electronic products that emit radiation, animal products, cosmetics, and even manufacture of tobacco products. FDA is responsible for the quality of shellfish, safety of cardiac stents, Over the Counter (OTC) cough syrups, HIV drug regimens, tetanus shots, artificial sweeteners, mammography standards, toothpaste, pediatric medicines, pet food, vitamins, and lipsticks, not to mention the readability of calorie and trans fat information on a bag of potato chips. The scope of FDA’s activities is so broad, and the number of decisions, approvals, clearances, recalls, hearings, and regulatory reports generated is too widespread to easily summarize. The FDA has created a portal on its Web page to present links to information and reports. That portal, titled “FDA-Track: Agency-Wide Program Performance,”1 organizes noteworthy developments and performance reports for each center and also links to those reports by month and year. The economic impact of the FDA is difficult to calculate, the scientific challenges and increasing medical needs overwhelming, and the expectations contradictory.
