US FDA to tighten drug reporting

The US Food and Drug Administration is planning new regulations totighten company reporting on drug reaction issues and will, for the first time, require manufacturers to provide an overall evaluation of a particular product's safety profile.

Under the new rule, manufacturers would be required to issue safety updates on a periodic basis, which would include data on patient numbers taking the drug, details of their age and sex and their reactions to it worldwide.

Anne Trontell, a deputy director in the agency's Office of Postmarketing Drug Risk Assessment, said that some painful lessons had been learned from trying to contain problems once dangerous reactions in marketed drugs had been detected, and that sending "Dear Doctor" letters describing side effects and how to prevent them had proved largely ineffective, reports Reuters.