FDA's ideas for safer drugs

FDA has issued a series of concept papers recommending specific pre- and post-marketing strategies to improve the safety of approved drugs. The papers, which are posted for comment on FDA's website, focus on methods to optimize safety studies and pharmacovigilance, without addressing how approval times for new products might be affected.

In its "Premarketing Risk Assessment" concept paper, the agency offers suggestions for what an ideal product safety database would look like - including recommendations for safety data from placebo- or comparator-controlled safety trials. Specifically, FDA calls for comparative safety trials to be conducted when background rates of adverse events need to be characterized; to establish comparable safety or tolerability to a marketed product; and to claim superiority over a marketed compound. ...