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Experimental drug saves babies, but FDA hurdle remains
Dr. Mark Puder of Boston Children’s Hospital developed a treatment with a drug made with fish oil called Omegaven that he’s been using to help reverse fatal liver disease in infants. Despite the drug’s effectiveness, it has yet to be approved by the Food and Drug Administration. Puder says that the FDA has told him they want the usual rigorous controlled study where half the patients get the experimental drug and the other half does not. Puder refuses to do the randomized drug trial because it would mean that some infants may die. Dr. Nancy Snyderman reports.