FDA: Ex-Official Blasts New Pediatric Trial Requirement

      The Food and Drug Administration's new requirement that pharmaceutical companies include pediatric testing in the drug approval process will raise drug prices and is a "rigid centralized governmental solution to a nonproblem," former FDA official Dr. Henry Miller argues in yesterday's Baltimore Sun. Miller states that the FDA seems not to care about the difficulties involved in testing drugs in children, such as ethical problems, a scarcity of disease participants and the many age-groups -- newborns, infants, preschoolers, primary schoolers and teenagers -- that must be tested. As evidence that the FDA imposes "expansive, rigid" and unnecessary regulations that are "inimical to free-market forces," Miller cites an approval process that has increased from an average of 8.1 years to 15.2 years over the past three decades, and notes that "the United States' $500 million tab for each drug approved is by far the most expensive in the world." He proposes some alternatives, such as requiring prominent labeling on drugs indicating they have not been tested on children, or publishing an annual list of such drugs. Predicting that newly-sworn FDA commissioner Jane Henney will "show a greater commitment to rhetoric than to the reality of protecting the public health," Miller concludes, "The FDA's new regulation is the latest example of Big Brother deciding where the private sector's scarce resources for research and development are best spent" (12/21). Click here for previous coverage of pediatric drug testing.