DIETARY SUPPLEMENTS: FDA Under Fire for Pregnancy Drug
The FDA is drawing fire for its approval of dietary supplements to treat morning sickness and leg swelling in pregnant women without knowing what effects the drug will have on fetuses. Opponents of the rule, which will take effect Monday, argue that supplements are not subjected to the same safety and effectiveness testing other therapies are. The advocacy group Public Citizen brought the issue to the fore, sparking other criticism from leading experts. Dr. Godfrey Oakley, former director of the CDC's division on birth defects said, "In the public health community, the rules should not be in the direction of promoting the use of untested products for women during pregnancy" (Stolberg, New York Times, 2/4). Dr. Philip Landrigan of New York's Mount Sinai Hospital agreed, writing in a letter to the FDA that the rule "runs counter to medical understanding and practice." He added, "This decision has the potential to put pregnant women and their offspring at serious risk" (AP/Charlotte Observer, 2/4). An FDA spokesperson said the agency would "carefully consider" their concerns (New York Times, 2/4).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.