October 16, 2014—The Health Resources and Services Administration has told an undetermined number of orphan drug manufacturers that they are out of compliance with 340B statutory requirements and their pricing agreements with the government and must notify it of their plans to repay affected rural and freestanding cancer hospitals for overcharges. It is HRSA's most significant … [Read more...]
Archives for October 2014
HRSA Ramps Ups 340B Oversight of Centers, Clinics, and HIV/AIDS Programs
Grantees' site visits expanded to address 340B complianceOctober 16, 2014—The Health Resources and Services Administration has started asking its grantee health centers, specialized clinics, and Ryan White HIV/AIDS programs about their 340B compliance during site visits, and their answers could trigger "further investigation," HRSA's Office of Pharmacy Affairs announced in its latest monthly 340B program update. … [Read more...]
PhRMA Files New Suit to Dodge 340B Orphan Drug Discounts
HRSA's interpretative rule is "flawed," drugmakers argueOctober 9, 2014—Brand-name drug manufacturers filed suit in federal district court today seeking to invalidate the 340B orphan drug exclusion interpretative rule. … [Read more...]
Lawmakers Question Skyrocketing Generic Drug Prices
One common antibiotic's cost rose over 8,000% in just 6 months, they noteOctober 8, 2014—Sen. Bernie Sanders (I-Vt.) and Rep. Elijah E. Cummings (D-Md.) have sent letters to 14 pharmaceutical manufacturers asking them to explain why the prices of some of their generic drugs have risen so sharply. … [Read more...]
Hospitals Rebut 340B Study’s Conclusions
Hospitals groups have issued strong rebuttals of a new study in the journal Health Affairs that its authors say supports criticism by the drug industry and others that disproportionate share hospitals increasingly use 340B savings to help themselves at the expense of the poor. In a reply article published in Health Affairs, Safety Net Hospitals for Pharmaceutical Access says … [Read more...]
Hospitals Rebut Health Affairs Study’s 340B Conclusions
Researchers say their analysis backs arguments made by drug industry and other criticsOctober 7, 2014—Hospitals groups have responded forcefully to a new study in the journal Health Affairs that its authors say supports the position that disproportionate share hospitals increasingly use 340B savings to help themselves at the expense of the poor. … [Read more...]