Three members of an Institute of Medicine committee that looked at the ethics and science of FDA-required postmarketing safety research say such studies place on the agency “a measure of ethical responsibility for the welfare of the study participants.” The committee members described their work and recommendations in an article published online by the New England Journal of Medicine.
They said that FDA's ethical responsibility is particularly strong when the patients' treatment is determined by the study, such as in a randomized trial.
The report said that “the responsibilities of FDA to research participants mean that it should mandate a randomized design only if it ‘has concluded that that an observational study could not provide the necessary information [to help answer the important public health question at issue], that a randomized, controlled trial is likely to generate the information within the necessary timeframe, and that the necessary randomized, controlled trial is ethically acceptable.”
While “the IoM committee stopped short of calling on FDA to increase public access to such data,” according to the report, it “recommended that the agency initiate a process to determine ways to ‘appropriately balance public health, privacy, and proprietary interests.'”