Via the Pink Sheet:
FDA could use more authority to bring negotiations over a drug's Risk Evaluation and Mitigation Strategy to a close, Principal Deputy Commissioner Joshua Sharfstein indicated during a House Energy and Commerce Health Subcommittee hearing on March 10.
The agency can require a REMS, but not specify its contents, he explained, noting the drug sponsor proposes a REMS and negotiates the final strategy with FDA.
"It's very important for us to work with companies to come up with something that works," Sharfstein said. "There's no question there's a lot we learn from the interchange with companies," but it sometimes can take a long time to come to agreement, and a level of consistency between REMS may be desirable if one approach makes sense.
The agency is open to discussions about how it can more effectively move to closure on these strategies designed to protect public health, he said.
Rep. John Shimkus, R-Ill., newly designed as the subcommittee's acting ranking member, suggested a limit on the time allowed for negotiations. Sharfstein noted that if an application is pending, companies have an incentive to finalize a plan; the problem arises particularly with drugs already on the market.
Another area that needs to be addressed, Sharfstein suggested, is the different treatment of brand and generic drugs when it comes to imposing a REMS with a communication plan for alerting health care professionals and patients about a drug's risk. Brand sponsors must implement such a plan, whereas FDA must pay for and operate a communication plan for generic drugs, he noted.
