Critics Debate the Use of Unscientific Factors in FDA Drug Approvals
The Baltimore Sun on Monday examined how some critics are saying that FDA or another government entity should "look beyond the safety of the foods and drugs it regulates and consider decidedly unscientific factors, including the ethics and health care costs of approving certain products." Such a move would "represent a radical departure for the FDA, which prides itself on making data-driven decisions free from political and industry influence," according to the Sun.
The Sun reports that issues raising ethical and social behavioral issues include considerations of the emergency contraceptive Plan B for over-the-counter sales and the possibility of products that are derived from cloned animals being sold .
For example, a survey by the Pew Initiative on Food and Biotechnology in October 2005 found that 63% of 1,000 people interviewed believed the government should consider moral and ethical issues when making decisions about cloning or genetically modifying animals.
Michael Fernandez, executive director of the Pew Initiative, said the survey proves "moral and ethical issues are things that consumers feel are important parts of the public debate."
However, opponents of the stance say, if the agency were to consider such factors in its decisions, its credibility could suffer, and it could lose its scientific focus. "That's not what the FDA was created to do," Michael Taylor, a former deputy FDA commissioner for policy, said (Rockoff, Baltimore Sun, 1/9).