Medical licensure laws and legal informed consent requirements protect patient safety, promote shared decision making, and foster public trust in the profession. In the view of April contributors, however, other types of regulation are more troubling. These include mandated actions—e.g., making a woman view an ultrasound before an abortion and reporting possible child neglect—and prohibited actions—e.g., the “gag” on discussing gun safety with parents. Third-party activities that restrict access to certain drugs or function to maintain high drug prices also interfere with ideal standards of clinical patient care.
Fifty-seven percent of women in a recent large study did not want to view their ultrasounds before their abortions, suggesting that mandated viewing interferes with uncoerced consent to care, a hallmark of medical ethics.
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.