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The Senate passed legislation Monday that would bar PBMs or insurers from including gag clauses in their contracts with pharmacies, sending the bill to the House by a vote of 98-2. Read More
Lawmakers are hoping to quickly reconcile the Senate’s newly-passed Opioid Crisis Response Act (S. 2680) with the package the House passed as soon as Friday and vote through a final bill next week. Read More
The FDA Tuesday added immediate-release opioids to its risk evaluation and mitigation strategy (REMS) for opioid analgesics, saying the move will encourage “rational prescribing.” Read More
FDA Commissioner Scott Gottlieb announced a revised agreement between the agency and states on interstate distribution of compounded drugs, responding to concerns that the existing distribution limits are too low. Read More
FDA Commissioner Scott Gottlieb said the agency plans to scrap its existing guidance on developing new pain drugs and replace it with guidances designed to promote development of new opioid alternatives and improve benefit and risk assessments of new opioid drugs in the works. “Everything is on the table,” Gottlieb said in announcing the move aimed at driving innovation for fresh options to the potent, addictive pain meds. He noted the initiative will include at least four new guidances. Read More
The FDA released final guidance for drug sponsors on the content and formatting of physiologically-based pharmacokinetic (PBPK) analyses, including an expanded section on formatting and a simplified section on software. Read More
Drug sponsors may not have to prove that a proposed medicine-assisted therapy helps addicts completely kick opioids but they will have to detail how well it helps cut dependence to win FDA approval, the agency says in a new draft guidance. Read More