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Which drugs need pediatric testing?

In an effort to get more drugs tested and appropriately labeled for children, the Food and Drug Administration Modernization Act (FDAMA) was signed into law in November 1997. FDAMA includes a provision to provide pharmaceutical companies a six-month extension of market exclusivity for drugs studied for pediatric use. To provide guidance to the pharmaceutical industry, the FDA worked with the Academy to compile a list of more than 500 drugs that need pediatric studies.

In spite of the generic drug industry's lawsuit against FDAMA, the FDA is moving the process forward. In this current phase, the agency must decide which of the 500 drugs will be tested first. Again, the agency is looking to the expertise of AAP members for advice. Based on your personal experience or subspecialty, which drugs are most important to be studied first? Please include up to 20 of your top recommendations, including age groups and indications for which the drug needs to be studied. If you are interested in viewing the FDA's current list of 500, you can find it on the Web at www.fda.gov/cder/pediatric/ and click on "List of Approved Drugs for Which Additional Pediatric Information is Needed."