US FDA’s Help May Get Charleston’s Hydexor Through Second Advisory Committee
After appealing FDA’s rejection, Charleston narrowly tailored the proposed indication for its emesis-reducing opioid to an in-patient population and crafted its own REMS to try and address advisors past safety concerns. Briefing documents indicate the FDA might have been learning towards approving the drug on the earlier review cycle, but the initial advisory committee vote shifted the agency’s thinking.
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US FDA advisory committee votes down Charleston’s emesis-reducing opioid once again, citing a poorly worded indication and REMS, along with a general lack of confidence that risk management plans can be successful in the real world.
Trump administration effort to reduce drug prices by curtailing agency program requiring new approvals for some old products undermines FDA’s role in policing the safety of prescription drugs, experts say.
Medicare actuaries indicate the ‘most-favored nations’ plan could limit patients’ access to medicine, though CMS’ Verma says she has confidence manufacturers won’t let that happen. Loss of access, combined with expected legal challenges, may make Democrats wary of embracing the Trump team’s last-minute rule, despite general agreement on the underlying policy idea. A Part D reference pricing policy is still in the works, CMS said.