Pharma Industry
Industry: Email Alert RSS FeedPediatric drug testing bill passes in Senate.(Markets)(Brief Article)
Chemical Market Reporter, August, 2003
THE SENATE has approved legislation that would require pharmaceutical companies to study the safety of their drugs in children. The House of Representatives must still pass the bill before it can become law. The Food and Drug Administration (FDA) had required pediatric drug testing, but a federal court ruled last October that the agency did not have the authority to require such studies.
Most drugs are tested only in adults. Up to three-quarters of all drugs prescribed for children are not tested specifically for their use. To encourage testing in children, Congress in 1997 created incentives for drugmakers, awarding them an extra six months of marketing exclusivity without generic competition for each medicine studied in children. Since then....
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