- Center on Health Equity and Access
- Clinical
- Health Care Cost
- Health Care Delivery
- Insurance
- Policy
- Technology
- Value-Based Care
FDA Pushes Rule on Labeling by Generics to Next Year
With an aim to create parity between brand-name and generic drugs, the FDA was expected to pass a rule next month that would allow generic manufacturers to independently provide safety updates on their labels. The decision has now been pushed back by 9 months.
A controversial new rule for updating generic drug labeling that the FDA was expected to finalize next month will not be published until the fall of 2015, an agency spokeswoman says.
The rule, which the FDA proposed last year, would allow generic drug makers to independently update safety warnings, something that only brand-name drug makers can currently do before receiving FDA permission.
The agency proposed the rule in response to a 2011 U.S. Supreme Court decision that federal law does not permit generic drug makers to make such changes independently and, therefore, they should not be held accountable for a failure to warn against a risk.
The court ruling sparked an outcry that generic labeling would be insufficient to warn patients about the risks associated with numerous medications, especially at a time when 86% of all prescriptions filled are for generic drugs, according to the IMS Institute for Healthcare Informatics.
Complete article on The Wall Street Journal : http://on.wsj.com/1vqiSe2
Public Hospitals More Likely to Extend Unprofitable Services After 340B Participation, Study Finds
May 10th 2024Public hospitals were significantly more likely to sustain access to unprofitable services following 340B Drug Pricing Program participation, while nonprofit hospitals were mostly unaffected, according to a recent study.
Read More
Frameworks for Advancing Health Equity: Urban Health Outreach
May 9th 2024In the series debut episode of "Frameworks for Advancing Health Equity," Mary Sligh, CRNP, and Chelsea Chappars, of Allegheny Health Network, explain how the Urban Health Outreach program aims to improve health equity for individuals experiencing homelessness.
Listen
Persistence Pays Off With Zanubrutinib: A Challenging CLL Case With a Prior BTK Inhibitor Failure
May 10th 2024The case of a 77-year-old woman with a long chronic lymphocytic leukemia (CLL) history illustrates the novel use of zanubrutinib as a potential option for some patients who have failed first-generation Bruton tyrosine kinase (BTK) inhibitors and venetoclax.
Read More
CMS Medicare Final Rule: Advancing Benefits, Competition, and Consumer Protection
May 7th 2024On this episode of Managed Care Cast, we're talking with Karen Iapoce, senior director of government products and programs at ZeOmega, about the recent CMS final rule on Medicare Part D and Medicare Advantage.
Listen
