Legislative and Administrative Changes Needed to Improve Regulation of Drug Industry

摘要

A considerable amount of misbranded and adulterated drug products get on the market because the Food and Drug Administration (FDA) does not have legislative authority to detain the products administratively prior to formal seizure action. The Congress should amend the Food, Drug, and Cosmetic Act to give FDA this authority. FDA has increased emphasis on voluntary compliance with regulations. However, FDA does not know the extent to which voluntary compliance is working. FDA needs to develop a mechanism to measure the extent to which allowing voluntary corrective actions promised by firms violating FDA-administered laws and regulations result in compliance. This report also recommends actions FDA should take to reduce the number of proposed regulatory actions which are subsequently disapproved and to improve followup on unresolved deficiencies found in prior inspections.