1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

340B Drug Audits: HRSA Reviewing 51 Entities In 2012

 
• By Scott Steinke

In its first year of auditing 340B facilities for compliance with drug discount rules, the HHS agency is investigating 45 randomly selected entities and six “targeted” entities that are the subject of specific allegations of non-compliance. About 250 hospitals have been decertified from 340B and may have to pay back discounts to drug makers.

The HHS Office of Pharmacy Affairs has launched on-site audits of 51 health care facilities that receive the federal 340B program’s deep discounts on outpatient drugs to ensure that they are in compliance with program regulations.

“OPA this year has selected 51 sites for audit,” OPA Director Krista Pedley said at the Annual 340B Coalition Conference...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United States

Crosstalk On Drug Pricing: Conflicts In Trump Team Rhetoric And Policy

 
• By Michael McCaughan

The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.

Price Inflation Rebates: Biden Policies Add Teeth To Trump’s Pharma Tariff Threat

 
• By Cathy Kelly

Companies with significant exposure to Medicare and Medicaid have fewer options for passing along higher costs to consumers because of price controls in the programs.

US FDA Acting Drug Center Chief Corrigan-Curay Retiring, Senior Staff Remake Continues

 
• By Derrick Gingery

The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

More from North America

US FDA’s Elsa AI Platform Is Not Guiding Regulatory Decisions, Official Says

 
• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

Branch Chief Vijay Kumar Named Acting Head Of US FDA’s Cell, Gene Therapy Office

 
• By Derrick Gingery

Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.