Clinton Plans New Rules On Child Drug Safety

US President Bill Clinton has proposed rules to make drugmakers test ifprescription and over-the-counter medicines sold to adults are safe and effective for children, and to put this information on drug labels. The plan would cost the US drug industry an estimated $13.5-$20.9 million annually.

Currently, doctors often have to guess safe children's dosages and, according to the draft rules, they are sometimes forced to choose between "prescribing prescription drugs without well-founded dosing and safety information or utilizing other potentially less effective therapy."

Under the plan, the Food and Drug Administration would decide, when a company seeks approval to test an experimental drug, if it has pediatric use potential. If this was the case, the company would have to provide a plan to find the safe and effective children's dose. Large clinical trials would not be required, just testing to find the correct pediatric dosage, which it is felt could be determined within three to six months. About 12 new drug approvals each year are expected to be affected, said the FDA, but while firms which do not comply with the rules will face court action and fines, it would be unethical to delay approvals or use product recalls to force the issue.