Research is often conducted without the knowledge or consent of those whose tissues are banked and poses possible harms to social groups if information about a few members is unscientifically applied to all.
Some commentators say comparative trials of FDA-approved drugs are overburdened by current Common Rule regulations and that researchers should not be required to obtain explicit consent for participation in the most innocuous of these trials.
The FDA’s approval for over-the-counter sales of emergency contraception marked a departure from its standard approval process and obstructed access to a safe and effective drug. That departure could set a dangerous precedent for future decisions.