The Consequences of Caronia: Impact On FDA’s Off-Label Regulation
• By Kate Rawson
The government has decided not to appeal the Second Circuit’s Caronia off-label promotion ruling – no doubt in part because of concerns about the broad reading of the First Amendment currently in favor at the Supreme Court. Officially, FDA has adopted a low-key response. Unofficially, agency officials – notably Bob Temple – are outraged by the ruling. What does Caronia mean for the future of FDA regulation and off-label prosecutions?
The Food & Drug Administration has made two public statements about the off-label promotion case United States v.Caronia since the Second Circuit Court of Appeals handed down its landmark (and controversial) decision
on
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.
The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.
MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.
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.
