HHS downplays latest attempt to predict “complex behavior changes to a broken system.”
The Congressional Budget Office estimates the HHS Office of Inspector General’s proposed rule to eliminate manufacturer rebates would increase federal spending on Medicare Part D by about $170bn from 2020-2029.
The proposed rule would revise the existing anti-kickback safe harbor for rebates and replace it with a safe harbor that protects upfront discounts that are passed through to beneficiaries at the point of sale through a new “chargeback” system
The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.
The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.
The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.
