The REMS Ramp Up: FDA Using New Safety Tools More Frequently In Year Two
• By Michael McCaughan
FDA has invoked formal Risk Evaluation & Mitigation Strategy Authority almost as often the last five months as it did in the first full year of the program. Use of more intense REMS-those with communication plans and elements to assure safe use-is increasing even faster, and indications are this is the leading edge of a wave of new restrictive programs. REMS unquestionably delay approvals, FDA officials acknowledge-and yet, more drugs are coming out of FDA.
FDA is using its new Risk Evaluation & Mitigation Strategy
authorities much more frequently in the second year since the law
took effect.
The REMS provisions began in March 2008. By FDA's count, the
agency invoked the new authority 34 times during the ensuing 12
months.
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