Publications and Presentations
04/06/21 – Article
Brenda M. Maloney Shafer "To Be or Not to 340B: HHS Issues Advisory Opinion and New GAO Report Sheds Light on HRSA’s Enforcement Pullback" Pratt's Government Contracting Law Report By: Brenda M. Maloney Shafer, Richard B. Davis, David M. BlankMany drug manufacturers have decided that the Health Resources and Services Administration’s Office of Pharmacy Affairs guidance on contract pharmacy arrangements is no longer binding. Accordingly, some have curtailed selling 340B-priced drugs based on contract pharmacy encounters, causing a significant... Read More
01/05/21 – Blog
The End of a Wild Year for 340B: HHS Issues Advisory Opinion and New GAO Report Sheds Light on HRSA’s Enforcement Pullback To Be Or Not To 340B Brenda M. Maloney Shafer, Richard B. Davis, David M. Blank
08/20/20 – Newsletter
AstraZeneca to Cut Off 340B Pricing for Contract Pharmacies on October 1 Health & Life Sciences Alert Brenda M. Maloney Shafer, Richard B. Davis
07/10/20 – Newsletter
Notice to Covered Entities: Manufacturer Seeking 340B Claims Data To Be or Not to 340B Blog Brenda M. Maloney Shafer, Richard B. Davis
04/30/20 – Newsletter
CMS Publishes 340B Drug Acquisition Cost Survey: Respond by May 15, 2020 To Be or Not to 340B Blog Brenda M. Maloney Shafer, Richard B. Davis
03/23/20 – Newsletter
HRSA Unveils New 340B Flexibilities During COVID-19 Crisis To Be or Not to 340B Blog Brenda M. Maloney Shafer, Richard B. Davis
03/13/20 – Newsletter
USP Appeals Panel Grants Appeals to USP 795 and 797, Denies Appeal to USP 825 Health & Life Sciences Alert Cory J. Kopitzke, Brenda M. Maloney Shafer
02/03/20 – Newsletter
GAO Report Suggests Increased Oversight of 340B Program To Be or Not to 340B Blog Brenda M. Maloney Shafer, Richard B. Davis
11/06/19 – Newsletter
Answers to Questions About USP's Notice of Intent to Revise New Compounding Standards Health & Life Science Alert Sarah E. Coyne, Brenda M. Maloney Shafer, Cory J. Kopitzke
09/24/19 – Newsletter
USP Publishes Notice of Intent to Revise New Compounding Standards Health & Life Sciences Alert Brenda M. Maloney Shafer, Cory J. Kopitzke
09/18/19 – Newsletter
New PBM State Laws Indicate a Shifting Battlefront over 340B Program Drug Pricing To Be or to Not to 340B Blog Brenda M. Shafer, Richard B. Davis
08/06/19 – Newsletter
Interesting 340B Takeaways from 2020 OPPS Proposed Rule To Be or Not to 340B Blog Brenda M. Maloney Shafer, Richard B. Davis, Benjamin A. Lockwood
07/18/19
"The 340B Drug Pricing Program Year in Review: What's Smoke and What's Fire in a Changing Landscape" Quarles & Brady Pharmacy Law Symposium
07/09/19 – Blog
340B Litigation Updates and Other Program Developments To Be or Not to 340B Brenda M. Shafer, Richard B. Davis
03/19/19 – Newsletter
The President’s 2020 Budget Keeps 340B Program in the Spotlight To Be or Not to 340B Brenda Maloney Shafer, Richard Davis
02/25/19 – Blog
"CVS Caremark Reverses Planned Payment Cuts to 340B Providers" To Be or Not to 340B Brenda M. Shafer, Richard B. Davis
01/29/19 – Blog
"We're 340Back! Review of Major Developments to the 340B Program" To Be or Not to 340B Brenda M. Shafer and Richard B. Davis
09/15/16 – Newsletter
Arizona Supreme Court Clarifies Deadline By Which Non-Hospital Health Care Providers Must Record Liens Health Law Alert Scott Klundt, Christopher Dang, Brenda Maloney Shafer
10/01/15 – Newsletter
The 340B Program Mega Guidance: Muddying the Water for All Stakeholders Health Law Alert Alyce C. Katayama, Edward D. Rickert, Brenda M. Maloney Shafer, Elizabeth R. Gebarski
Brenda M. Maloney Shafer
