Drug policy in United States of America

Abstract

The USA federal prescription drug policies are inconsistent. The federal government regulates the development, production, marketing and safety of prescription drugs in the country through various legal mechanisms as well as private and governmental institutions. Patent laws also play an important role in this process protecting the pharmaceutical industry. The government has no direct mechanism to control prices of prescription drugs nor does it have a policy to cover the whole US population with a prescription drug benefit. The FDA is the agency charged with regulation of medicines. Various laws have been enacted over the years to improve quality control, safety and ensure efficacy of prescription drugs as: Prescription Drug User Fee Act (PDUFA) and Food and Drug Administration Modernization Act (FDAMA), as well as increase patient access to prescription drugs (Fast Track; Orphan Drug Act, Pediatric exclusivity). The Hatch-Waxman Act, named for its authors, has played an important role in the development of generic drugs with much success and a significant effect on drug prices. The insurance health system is voluntary and also inconsistent offering various forms of insurance that range from the individual applying for insurance personally, through employer financed health insurance, to government run health insurance systems. All health insurance may or may not have a prescription drug benefit.