FDA forms risk subcommittee

FDA announced on Tuesday the creation of a new drug safety and risk management subcommittee of the Pharmaceutical Science Advisory Committee. The subcommittee primarily will focus on post-approval issues, Martin Himmel, deputy director of the office of postmarketing drug risk assessment at FDA told BioCentury. It will be consulted on risk management programs for specific drugs, and may hold joint meetings with drug review advisory committees.

In addition to drug-specific advice, the subcommittee will provide input into the development of new pharmacovigilance and risk management policies, Himmel said (see BioCentury, Nov. 12). "There has been a recognition over the last several years that the safety of a drug involves more than just the intrinsic safety of a molecule, that it also includes how it is used. And there has been a recognition that tools [FDA can] apply to risk management, such as 'Dear Doctor' letters and black box warnings, have limited effectiveness," Himmel noted. ...